synonymDrug Administration Law(Drug Administration Law) Generally refers to the Drug Administration Law of the People's Republic of China
The Drug Administration Law of the People's Republic of China is a law formulated to strengthen drug administration, ensure drug quality, safeguard the safety and legitimate rights and interests of the public in drug use, and protect and promote public health.[3]Adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and effective as of July 1, 1985.
On August 26, 2019, the newly revised Drug Administration Law of the People's Republic of China was adopted at the 12th meeting of the Standing Committee of the 13th National People's Congress and came into force on December 1, 2019.[1][3]
Chinese name
Drug Administration Law of the People's Republic of China
Adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984
Revised for the first time at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001
On December 28, 2013, the Sixth Meeting of the Standing Committee of the Twelfth National People's Congress amended the Decision on Amending Seven Laws Including the Marine Environment Protection Law of the People's Republic of China for the first time
The Decision on Amending the Pharmaceutical Administration Law of the People's Republic of China at the 14th Meeting of the Standing Committee of the Twelfth National People's Congress on April 24, 2015 was amended for the second time
Revised for the second time at the 12th Meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019[2]
Full text of law
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general provisions
Chapter II Drug Development and Registration
Chapter III Holders of Drug Marketing Licenses
Chapter IV Pharmaceutical Production
Chapter V Pharmaceutical Trading
Chapter VI Pharmacy Administration of Medical Institutions
Chapter VII Post marketing Management of Drugs
Chapter VIII Drug Prices and Advertising
Chapter IX Drug Reserve and Supply
Chapter X Supervision and Management
Chapter XI Legal Liability
Chapter XII Supplementary Provisions
general provisions
Article 1 This Law is formulated with a view to strengthening drug control, ensuring drug quality, safeguarding the safety and legitimate rights and interests of the public in drug use, and protecting and promoting public health.
Article 2 This Law applies to the research, production, trade, use, supervision and administration of drugs within the territory of the People's Republic of China.
The term "drugs" as used in this law refers to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions, and stipulate indications or main functions, usage and dosage, including traditional Chinese medicine, chemical drugs and biological products.
Article 3 Drug administration should focus on people's health, adhere to the principles of risk management, full process control and social co governance, establish a scientific and strict supervision and management system, comprehensively improve drug quality, and ensure the safety, effectiveness and accessibility of drugs.
Article 4 The State develops modern medicine and traditional medicine, giving full play to their roles in prevention, medical treatment and health care.
The State protects the resources of wild medicinal materials and varieties of traditional Chinese medicines, and encourages the cultivation of authentic traditional Chinese medicines.
Article 5 The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.
Article 6 The State implements a system of drug marketing license holders for drug administration.The holder of drug marketing license shall be responsible for the safety, effectiveness and quality controllability of drugs in the whole process of drug development, production, marketing and use according to law.
Article 7 Those engaged in drug research, production, marketing and use shall abide by laws, regulations, rules, standards and norms, and ensure the authenticity, accuracy, integrity and traceability of information throughout the process.
Article 8 The drug regulatory department under the State Council shall be in charge of drug supervision and administration throughout the country.The relevant departments under the State Council shall be responsible for the supervision and administration related to drugs within their respective functions and responsibilities.The drug regulatory department under the State Council shall cooperate with the relevant departments under the State Council to implement the national drug industry development plan and industrial policies.
The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of pharmaceuticals within their respective administrative areas.The departments responsible for drug supervision and administration under the people's governments of cities divided into districts and counties (hereinafter referred to as drug supervision and administration departments) are responsible for drug supervision and administration within their respective administrative areas.The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of drugs within the scope of their respective duties.
Article 9 The local people's governments at or above the county level shall be responsible for the drug supervision and administration within their own administrative areas, uniformly lead, organize and coordinate the drug supervision and administration within their own administrative areas and the response to drug safety emergencies, and establish and improve the drug supervision and administration mechanism and information sharing mechanism.
Article 10 People's governments at or above the county level shall incorporate drug safety work into their national economic and social development plans, include drug safety work funds into their government budgets, strengthen drug supervision and management capacity building, and provide guarantee for drug safety work.
Article 11 The pharmaceutical professional technical institutions set up or designated by the pharmaceutical supervisory and administrative departments shall undertake the review, inspection, verification, monitoring and evaluation work necessary for the implementation of pharmaceutical supervision and administration according to law.
Article 12 The State shall establish a sound drug traceability system.The drug regulatory department under the State Council shall formulate unified standards and specifications for drug traceability, promote the exchange and sharing of drug traceability information, and achieve drug traceability.
The State establishes a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other harmful reactions related to drug use.
Article 13 People's governments at all levels and their relevant departments, pharmaceutical industry associations, etc. shall strengthen the publicity and education of drug safety, and carry out the popularization of laws and regulations on drug safety.
The news media shall carry out public welfare publicity of knowledge such as drug safety laws and regulations, and supervise drug violations by public opinion.The publicity and report on drugs shall be comprehensive, scientific, objective and fair.
Article 14 The pharmaceutical industry association shall strengthen self-discipline in the industry, establish and improve industry norms, promote the construction of the industry's integrity system, guide and urge its members to carry out activities such as drug production and marketing according to law.
Article 15 The people's governments at or above the county level and their relevant departments shall, in accordance with the relevant regulations of the State, commend and reward the units and individuals that have made outstanding contributions to the development, production, trade, use, supervision and administration of drugs.
Chapter II Drug Development and Registration
Article 16 The State supports drug innovation that is guided by clinical value and has definite or special curative effects on human diseases, encourages the development of new drugs that have new therapeutic mechanisms, treat seriously life-threatening diseases or rare diseases, and have multiple targeted systemic regulatory and intervention functions on human beings, so as to promote the technological progress of drugs.
The State encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of traditional Chinese medicine, establish and improve a technical evaluation system consistent with the characteristics of traditional Chinese medicine, and promote the inheritance and innovation of traditional Chinese medicine.
The State takes effective measures to encourage the development and innovation of medicines for children, supports the development of new varieties, dosage forms and specifications of medicines for children that meet the physiological characteristics of children, and gives priority to the review and approval of medicines for children.
Article 17 Pharmaceutical research and development activities shall comply with the quality control standards for non clinical research and clinical trials of pharmaceuticals, so as to ensure that the whole process of pharmaceutical research and development continues to meet the statutory requirements.
The drug regulatory department under the State Council shall, together with the relevant departments under the State Council, formulate the quality control standards for non clinical drug research and the quality control standards for clinical drug trials.
Article 18 Non clinical drug research shall be carried out in accordance with the relevant provisions of the State, with personnel, sites, equipment, instruments and management systems appropriate to the research project, so as to ensure the authenticity of relevant data, materials and samples.
Article 19 To carry out clinical trials of drugs, relevant data, materials and samples, such as research methods, quality indicators, pharmacological and toxicological test results, shall be truthfully submitted in accordance with the provisions of the drug regulatory department under the State Council, and shall be approved by the drug regulatory department under the State Council.The drug regulatory department under the State Council shall decide whether to approve and notify the clinical trial applicant within 60 working days from the date of accepting the clinical trial application. If the applicant fails to notify within the time limit, it shall be deemed to have approved.The bioequivalence test shall be reported to the drug regulatory department under the State Council for the record.
Clinical trials of drugs shall be conducted in clinical trial institutions with appropriate conditions.Drug clinical trial institutions shall be put on record, and the specific measures shall be jointly formulated by the drug regulatory department under the State Council and the competent health department under the State Council.
Article 20 The clinical trial of drugs shall be carried out in accordance with ethical principles, and a clinical trial plan shall be formulated, which shall be examined and approved by the Ethics Committee.
The Ethics Committee shall establish an ethical review system to ensure that the ethical review process is independent, objective and fair, supervise and standardize the development of drug clinical trials, protect the legitimate rights and interests of subjects, and safeguard social and public interests.
Article 21 When carrying out a clinical trial of drugs, it is necessary to truthfully explain and explain the purpose, risks and other details of the clinical trial to the subjects or their guardians, obtain the informed consent signed voluntarily by the subjects or their guardians, and take effective measures to protect the legitimate rights and interests of the subjects.
Article 22 If safety problems or other risks are found during the clinical trial of drugs, the clinical trial sponsor shall timely adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the drug regulatory department under the State Council.When necessary, the drug regulatory department under the State Council may order adjustment of the clinical trial scheme, suspension or termination of the clinical trial.
Article 23 For drugs that are being used in clinical trials to treat diseases that seriously endanger lives and have no effective treatment means, if they may benefit from medical observation and conform to ethical principles, they can be used for other patients with the same condition in the institutions conducting clinical trials after examination and informed consent.
Article 24 Drugs listed in China shall be approved by the drug regulatory department under the State Council and obtain a drug registration certificate;However, the Chinese medicinal materials and prepared slices of Chinese medicinal materials that are not subject to examination and approval administration are excluded.The catalogue of Chinese medicinal materials and prepared slices under examination and approval administration shall be formulated by the drug regulatory department under the State Council in conjunction with the department in charge of traditional Chinese medicine under the State Council.
When applying for drug registration, authentic, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of drugs.
Article 25 With regard to the drugs applied for registration, the drug regulatory department under the State Council shall organize pharmaceutical, medical and other technical personnel to review the safety, effectiveness and quality controllability of the drugs, as well as the applicant's quality management, risk prevention and control, liability compensation and other capabilities;If the conditions are met, a drug registration certificate shall be issued.
When examining and approving drugs, the drug regulatory department under the State Council reviews and approves chemical APIs, relevant excipients, packaging materials and containers in direct contact with drugs, and drug quality standards, production processes, labels and instructions.
The term "auxiliary materials" as used in this Law refers to excipients and additives used in the production and dispensing of drugs.
Article 26 For the treatment of diseases that seriously endanger lives and have no effective means of treatment, as well as drugs urgently needed in public health, if the clinical trial of drugs has data showing the efficacy and can predict its clinical value, it can be approved with conditions, and the relevant matters can be clearly stated in the drug registration certificate.
Article 27 The drug regulatory department under the State Council shall improve the drug review and approval system, strengthen capacity building, establish and improve communication, expert consultation and other mechanisms, optimize the review and approval process, and improve the efficiency of review and approval.
The conclusion and basis of the review of approved drugs for marketing shall be made public according to law and subject to social supervision.The business secrets learned in the review and approval shall be kept confidential.
Article 28 Drugs shall meet the national drug standards.If the drug quality standards approved by the drug regulatory department under the State Council are higher than the national drug standards, the approved drug quality standards shall prevail;If there is no national drug standard, it shall meet the approved drug quality standard.
The Pharmacopoeia of the People's Republic of China and drug standards promulgated by the drug regulatory department under the State Council are the national drug standards.
The drug regulatory department under the State Council, together with the competent health department under the State Council, shall organize a pharmacopoeia committee to be responsible for the formulation and revision of the national drug standards.
The drug inspection institutions set up or designated by the drug regulatory department under the State Council shall be responsible for the calibration of national drug standards and reference materials.
Article 29 The names of drugs listed in the national drug standards are the generic names of drugs.If it has been used as a generic name of a drug, the name shall not be used as a drug trademark.
Chapter III Holders of Drug Marketing Licenses
Article 30 The holder of a drug marketing license refers to an enterprise or a drug research and development institution that has obtained a drug registration certificate.
The holder of a drug marketing license shall, in accordance with the provisions of this Law, be responsible for the non clinical research, clinical trials, production and marketing, post marketing research, adverse reaction monitoring, reporting and handling of drugs.Other units and individuals engaged in drug research, production, marketing, storage, transportation, use and other activities shall bear corresponding responsibilities according to law.
The legal representative and main person in charge of the holder of the drug marketing license shall be fully responsible for the drug quality.
Article 31 A holder of a drug marketing license shall establish a drug quality assurance system and assign special personnel to independently take charge of drug quality management.
The holder of the drug marketing license shall regularly review the quality management system of the entrusted drug manufacturing enterprise and drug handling enterprise, and supervise their continuous quality assurance and control ability.
Article 32 The holder of a drug marketing license may produce drugs on his own or entrust a drug producing enterprise with the production.
If the holder of a drug marketing license manufactures drugs on his own, he shall obtain a drug production license in accordance with the provisions of this Law;Where production is entrusted, qualified drug producing enterprises shall be entrusted.The holder of the drug marketing license and the entrusted manufacturing enterprise shall sign the entrustment agreement and the quality agreement, and strictly perform the obligations agreed in the agreement.
The pharmaceutical supervisory and administrative department under the State Council formulates guidelines for quality agreements for entrusted drug production, and guides and supervises the holders of drug marketing licenses and entrusted manufacturing enterprises in fulfilling their obligations of drug quality assurance.
Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and drug like precursor chemicals shall not be commissioned for production;However, unless otherwise stipulated by the drug regulatory department under the State Council.
Article 33 The holder of a drug marketing license shall establish procedures for the release of drugs for marketing, examine the drugs released from the factory by the drug manufacturing enterprise, and release them only after they are signed by the quality authorized person.Those that do not meet the national drug standards shall not be released.
Article 34 A holder of a drug marketing license may sell the drugs for which he has obtained the drug registration certificate on his own, or may entrust a drug handling enterprise to sell the drugs.A holder of a drug marketing license who engages in drug retail activities shall obtain a drug trading license.
A holder of a drug marketing license who sells drugs on his own shall meet the conditions prescribed in Article 52 of this Law;In case of entrusted sales, qualified drug distributors shall be entrusted.The holder of the drug marketing license and the entrusted enterprise shall sign the entrustment agreement and strictly perform the obligations agreed in the agreement.
Article 35 Where a holder of a drug marketing license, a drug manufacturing enterprise or a drug trading enterprise entrusts the storage and transportation of drugs, it shall evaluate the quality assurance capability and risk management capability of the entrusted party, sign an entrustment agreement with the entrusted party, stipulate the drug quality responsibility, operating procedures and other contents, and supervise the entrusted party.
Article 36 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall establish and implement a drug traceability system, provide traceability information in accordance with regulations, and ensure the traceability of drugs.
Article 37 Holders of drug marketing licenses shall establish an annual reporting system, and report the production and sales of drugs, post marketing research, risk management, etc. to the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government in accordance with regulations.
Article 38 If the holder of a drug marketing license is an overseas enterprise, the designated enterprise legal person in China shall perform the obligations of the holder of the drug marketing license and bear joint and several liabilities with the holder of the drug marketing license.
Article 39 The production enterprises of prepared slices of traditional Chinese medicine shall fulfill the relevant obligations of the holders of drug marketing licenses, implement the whole process management of the production and sales of prepared slices of traditional Chinese medicine, establish a traceability system of prepared slices of traditional Chinese medicine, and ensure the safety, effectiveness and traceability of prepared slices of traditional Chinese medicine.
Article 40 With the approval of the drug regulatory department under the State Council, the holder of the drug marketing license may transfer the drug marketing license.The transferee shall have the capability of quality management, risk prevention and control and liability compensation to ensure the safety, effectiveness and quality controllability of the drug, and perform the obligations of the drug marketing license holder.
Chapter IV Pharmaceutical Production
Article 41 Pharmaceutical production activities shall be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located and a pharmaceutical production license shall be obtained.No drug shall be produced without a drug production license.
A drug production license shall indicate the period of validity and the scope of production, and the license shall be re examined and issued upon expiration.
Article 42 Pharmaceutical production activities shall meet the following conditions:
（1） There are legally qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers;
（2） There are factory buildings, facilities and sanitary environment suitable for drug production;
（3） There are institutions, personnel and necessary instruments and equipment capable of conducting quality management and quality inspection on the drugs produced;
（4） There are rules and regulations to ensure the quality of drugs, and they meet the requirements of the pharmaceutical production quality control standards formulated by the pharmaceutical supervisory and administrative department under the State Council in accordance with this Law.
Article 43 Those engaged in pharmaceutical production shall abide by the quality control standards for pharmaceutical production, establish and improve the quality control system for pharmaceutical production, and ensure that the whole process of pharmaceutical production continues to meet the statutory requirements.
The legal representative and main person in charge of the drug manufacturing enterprise shall be fully responsible for the drug production activities of the enterprise.
Article 44 Drugs shall be produced in accordance with the national drug standards and the production process approved by the drug regulatory department.Production and inspection records shall be complete and accurate and shall not be fabricated.
The prepared slices of traditional Chinese medicine shall be processed in accordance with the national drug standards;Where there are no provisions in the national drug standards, they shall be processed in accordance with the processing specifications formulated by the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.The processing specifications formulated by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be reported to the pharmaceutical supervisory and administrative department under the State Council for the record.Those that do not meet the national drug standards or are not processed in accordance with the processing specifications formulated by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall not leave the factory or be sold.
Article 45 The raw materials and excipients needed for the production of drugs shall meet the requirements for medicinal use and the relevant requirements of the quality control standards for drug production.
In the production of drugs, the suppliers of raw materials and auxiliary materials shall be examined in accordance with regulations to ensure that the raw materials and auxiliary materials purchased and used meet the requirements of the preceding paragraph.
Article 46 Packaging materials and containers in direct contact with drugs shall meet the requirements for medicinal use and meet the standards for safeguarding human health and safety.
The pharmaceutical supervisory and administrative department shall order the unqualified packaging materials and containers that are in direct contact with pharmaceuticals to stop using.
Article 47 Pharmaceutical producing enterprises shall conduct quality inspection of pharmaceuticals.Those failing to meet the national drug standards shall not leave the factory.
Drug manufacturing enterprises shall establish procedures for the release of drugs from the factory and specify the standards and conditions for the release from the factory.Those conforming to standards and conditions can be released only after being signed by the quality authorized person.
Article 48 Pharmaceutical packaging shall meet the requirements of pharmaceutical quality and facilitate storage, transportation and medical use.
Chinese medicinal materials shall be packaged when shipped.On each package, the product name, place of origin, date, supplier, and the mark of qualified quality shall be indicated.
Article 49 Drug packages shall be printed or pasted with labels and instructions in accordance with regulations.
The label or instruction manual shall indicate the generic name, ingredients, specifications of the drug, the holder of the marketing license and its address, the manufacturer and its address, the approval number, the batch number of the product, the date of production, the period of validity, the indications or main functions, usage, dosage, contraindications, adverse reactions and precautions.The words in the labels and instructions shall be clear, and the production date, validity period and other matters shall be clearly marked for easy identification.
The labels and instructions of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs shall bear the prescribed marks.
Article 50 The holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions who work in direct contact with drugs shall undergo annual health examinations.Those who suffer from infectious diseases or other diseases that may contaminate drugs may not engage in work that directly contacts drugs.
Chapter V Pharmaceutical Trading
Article 51 Pharmaceutical wholesale activities shall be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located and a pharmaceutical trading license shall be obtained.To engage in drug retail activities, the approval of the drug regulatory department of the local people's government at or above the county level shall be obtained, and a drug trading license shall be obtained.Without a drug trading license, no one may trade in drugs.
A drug trade license shall indicate the period of validity and the scope of business, and the license shall be re examined and issued upon expiration.
When implementing the drug trade license, the drug regulatory department shall follow the principle of facilitating the purchase of drugs by the masses in addition to the conditions specified in Article 52 of this Law.
Article 52 Pharmaceutical trading activities shall meet the following conditions:
（1） There are legally certified pharmacists or other pharmaceutical technicians;
（2） Having business premises, equipment, storage facilities and a hygienic environment suitable for the drugs handled;
（3） Having a quality management organization or personnel appropriate to the drugs handled;
（4） There are rules and regulations to ensure the quality of drugs and meet the requirements of the quality control standards for drug handling formulated by the drug regulatory department under the State Council in accordance with this Law.
Article 53 Pharmaceutical trading activities shall comply with the quality management standards for pharmaceutical trading, establish and improve the quality management system for pharmaceutical trading, and ensure that the whole process of pharmaceutical trading continues to meet legal requirements.
The State encourages and guides drug retail chain operation.The headquarters of enterprises engaged in drug retail chain business activities shall establish a unified quality management system and perform management responsibilities for the business activities of their retail enterprises.
The legal representative and main person in charge of the drug handling enterprise shall be fully responsible for the drug handling activities of the enterprise.
Article 54 The State implements a classified management system for prescription drugs and non prescription drugs.The specific measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
Article 55 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall purchase drugs from holders of drug marketing licenses or enterprises with drug production and trading qualifications;However, the purchase of Chinese medicinal materials without examination and approval administration is excluded.
Article 56 When purchasing drugs, pharmaceutical trading enterprises shall establish and implement a system of inspection and acceptance of purchased drugs, and verify the drug certificates and other marks;Those that do not meet the specified requirements shall not be purchased or sold.
Article 57 Pharmaceutical trading enterprises shall keep true and complete records of the purchase and sale of pharmaceuticals.The purchase and sale record shall indicate the generic name, dosage form, specification, product batch number, validity period, marketing license holder, manufacturer, purchase and sale unit, purchase and sale quantity, purchase and sale price, purchase and sale date of the drug, and other contents specified by the drug regulatory department under the State Council.
Article 58 When retailing drugs, drug distributors should be accurate, and correctly explain the usage, dosage and precautions;The prescription for dispensing shall be checked, and the drugs listed in the prescription shall not be changed or substituted without authorization.The prescription with incompatibility or excessive dosage shall be refused to be dispensed;When necessary, the prescription can be dispensed only after being corrected or re signed by the prescribing physician.
Pharmaceutical trading enterprises selling Chinese medicinal materials shall indicate the place of origin.
Pharmacists or other pharmaceutical technicians who have been legally certified shall be responsible for the drug management, prescription verification and dispensing, rational drug use guidance and other work of the enterprise.
Article 59 Pharmaceutical trading enterprises shall formulate and implement a pharmaceutical storage system and take necessary measures for cold storage, freezing prevention, moisture-proof, insect prevention and rat prevention to ensure the quality of pharmaceuticals.
The inspection system shall be implemented for the warehousing and ex warehousing of drugs.
Article 60 Chinese medicinal materials may be sold in urban and rural fairs, unless otherwise stipulated by the State Council.
Article 61 Holders of drug marketing licenses and drug distributors selling drugs through the Internet shall abide by the relevant provisions of this Law on drug distribution.The specific administrative measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council and other departments.
Vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, drug like precursor chemicals and other drugs under special control of the State shall not be sold on the Internet.
Article 62 The third-party platform provider of online drug trading shall, in accordance with the provisions of the drug regulatory department under the State Council, file with the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located.
The third-party platform provider shall, in accordance with the law, review the qualifications of the drug marketing license holders and drug distributors who apply for access to the platform for operation, ensure that they meet the statutory requirements, and manage the drug trading activities on the platform.
If the third-party platform provider finds that the drug marketing license holder or drug handling enterprise entering the platform for business has violated the provisions of this law, it shall stop it in time and report it to the drug regulatory department of the local county people's government immediately;If serious violations are found, the provision of online trading platform services shall be stopped immediately.
Article 63 Medicinal materials newly discovered or introduced from abroad may be sold only after being approved by the drug regulatory department under the State Council.
Article 64 Drugs shall be imported from the ports where drug import is allowed, and the enterprises importing drugs shall file a record with the drug regulatory department in the place where the port is located.The customs shall go through the customs formalities on the strength of the customs clearance form for imported drugs issued by the drug regulatory department.If there is no customs clearance form for imported drugs, the customs shall not release them.
The drug regulatory department in the place where the port is located shall notify the drug inspection institution to conduct spot check and inspection of imported drugs in accordance with the provisions of the drug regulatory department under the State Council.
The ports for drug import shall be proposed by the drug regulatory department under the State Council in conjunction with the General Administration of Customs and submitted to the State Council for approval.
Article 65 If a medical institution needs to import a small amount of drugs urgently in clinic, it may import them with the approval of the drug regulatory department under the State Council or the people's government of a province, autonomous region or municipality directly under the Central Government authorized by the State Council.Imported drugs shall be used for specific medical purposes in designated medical institutions.
A small amount of drugs brought into the country for personal use shall be handled in accordance with the relevant provisions of the State.
Article 66 The import and export of narcotic drugs and psychotropic drugs within the scope prescribed by the State shall be subject to the import license and export license issued by the drug regulatory department under the State Council.
Article 67 It is prohibited to import drugs whose efficacy is uncertain, whose adverse reactions are serious, or which endanger human health for other reasons.
Article 68 The pharmaceutical supervisory and administrative department under the State Council shall appoint a pharmaceutical inspection institution to inspect the following pharmaceuticals before they are sold or imported:;Those that have not been inspected or have not passed the inspection shall not be sold or imported:
（1） Drugs sold in China for the first time;
（2） Biological products specified by the drug regulatory department under the State Council;
（3） Other drugs prescribed by the State Council.
Chapter VI Pharmacy Administration of Medical Institutions
Article 69 A medical institution shall be staffed with legally qualified pharmacists or other pharmaceutical technicians, who shall be responsible for the drug administration, prescription examination and dispensing, rational drug use guidance, etc. of the unit.Non pharmaceutical technicians shall not be directly engaged in pharmaceutical technical work.
Article 70 When purchasing drugs, medical institutions shall establish and implement a system of inspection and acceptance of purchased drugs, and verify the drug certificates and other marks;Those that do not meet the specified requirements shall not be purchased or used.
Article 71 A medical institution shall have a place, equipment, storage facilities and a hygienic environment suitable for the drugs it uses, formulate and implement a drug storage system, and take necessary measures such as cold storage, freezing prevention, moisture-proof, insect prevention and rat prevention to ensure the quality of drugs.
Article 72 Medical institutions shall adhere to the principle of safe, effective, economical and reasonable drug use, follow the guiding principles for clinical application of drugs, clinical diagnosis and treatment guidelines, drug directions and other rational drug use, and review the suitability of doctors' prescriptions and drug orders.
Drug users other than medical institutions shall abide by the provisions of this Law on the use of drugs by medical institutions.
Article 73 When dispensing prescriptions, pharmacists or other pharmaceutical technicians who have been legally certified shall check them, and drugs listed in the prescriptions shall not be changed or substituted without authorization.The prescription with incompatibility or excessive dosage shall be refused to be dispensed;When necessary, the prescription can be dispensed only after being corrected or re signed by the prescribing physician.
Article 74 To make preparations, a medical institution shall obtain the approval of the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located and obtain a preparation license for the medical institution.No pharmaceutical preparations may be made without a pharmaceutical preparation license of a medical institution.
The period of validity of the pharmaceutical preparation license of a medical institution shall be indicated, and the license shall be reexamined and issued upon expiration.
Article 75 When making preparations, medical institutions shall have facilities, management systems, inspection instruments and a hygienic environment that can guarantee the quality of preparations.
Medical institutions shall make preparations in accordance with the approved process, and the raw materials, excipients and packaging materials needed shall meet the pharmaceutical requirements.
Article 76 The preparations made by a medical institution shall be the varieties that the unit needs clinically but are not available on the market, and shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located;However, unless the law provides otherwise for the preparation of traditional Chinese medicine preparations.
The quality of preparations made by medical institutions shall be inspected in accordance with regulations;Those qualified shall be used in the unit with doctor's prescription.With the approval of the drug regulatory department under the State Council or the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government, the preparations made by medical institutions may be used among designated medical institutions.
The preparations made by medical institutions shall not be sold on the market.
Chapter VII Post marketing Management of Drugs
Article 77 The holder of a drug marketing license shall formulate a post marketing risk management plan, take the initiative to carry out post marketing research on drugs, further verify the safety, effectiveness and quality controllability of drugs, and strengthen the continuous management of marketed drugs.
Article 78 For the drugs approved conditionally, the holder of the drug marketing license shall take corresponding risk management measures and complete relevant research within the specified time limit as required;If the drug regulatory department under the State Council fails to complete the research as required within the time limit or fails to prove that the benefits outweigh the risks, it shall deal with them according to law until the drug registration certificate is cancelled.
Article 79 Changes made in the course of drug production shall be classified and managed according to their risks and effects on drug safety, effectiveness and quality controllability.If it is a major change, it shall be approved by the drug regulatory department under the State Council. Other changes shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council.
The holder of the drug marketing license shall, in accordance with the provisions of the drug regulatory department under the State Council, comprehensively assess and verify the impact of the changes on the drug safety, effectiveness and quality controllability.
Article 80 The holder of a drug marketing license shall carry out post marketing ADR monitoring, take the initiative to collect, track and analyze information on suspected ADRs, and take risk control measures for drugs with identified risks in a timely manner.
Article 81 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall regularly inspect the quality, efficacy and adverse reactions of the drugs produced, handled and used by their own units.If any suspected adverse reaction is found, it shall be reported to the drug regulatory department and the competent health department in a timely manner.The specific measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
For drugs that have been confirmed to have serious adverse reactions, the drug regulatory department under the State Council or the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, according to the actual situation, take emergency control measures such as stopping production, sales, and use, and shall organize an appraisal within five days, and make an administrative decision within fifteen days from the date of the appraisal conclusion.
Article 82 Where a drug has quality problems or other potential safety hazards, the holder of the drug marketing license shall immediately stop selling the drug, inform the relevant drug handling enterprises and medical institutions to stop selling and using the drug, recall the sold drugs, make public the recall information in a timely manner, and immediately stop production when necessary, and report the recall and handling of the drug to the provinces, autonomous regionsReport by the drug regulatory department and the competent health department of the people's government of the municipality directly under the Central Government.Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions shall cooperate.
If the holder of the drug marketing license should recall the drugs according to law but fails to recall them, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order him to recall them.
Article 83 The holder of a drug marketing license shall regularly carry out post marketing evaluation on the safety, effectiveness and quality controllability of the listed drugs.When necessary, the drug regulatory department under the State Council may order the holders of drug marketing licenses to carry out post marketing evaluation or directly organize post marketing evaluation.
The drug registration certificate shall be cancelled for drugs whose efficacy is uncertain, whose adverse reactions are serious or which endanger human health for other reasons.
Drugs whose drug registration certificates have been cancelled shall not be produced, imported, sold or used.
Drugs whose drug registration certificate has been cancelled or whose validity period has expired shall be destroyed under the supervision of the drug regulatory department or other harmless treatment measures shall be taken according to law.
Chapter VIII Drug Prices and Advertising
Article 84 The State shall improve the drug procurement management system, monitor drug prices, carry out cost price investigations, strengthen drug price supervision and inspection, investigate and deal with drug price violations such as price monopoly and price gouging, and maintain drug price order.
Article 85 For drugs whose prices are regulated by the market according to law, the holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall set the prices in accordance with the principles of fairness, reasonableness, honesty and credibility, and consistency between quality and price, so as to provide drugs with reasonable prices to drug users.
Pharmaceutical marketing license holders, pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions shall abide by the provisions of the competent drug pricing department under the State Council on drug price control, formulate and mark the retail price of drugs, and prohibit such acts as profiteering, price monopoly and price fraud.
Article 86 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall, in accordance with the law, provide the competent drug pricing departments with information on the actual purchase and sale prices and quantities of their drugs.
Article 87 Medical institutions shall provide patients with price lists of the drugs they use, truthfully publish the prices of their commonly used drugs in accordance with regulations, and strengthen the administration of rational drug use.The specific measures shall be formulated by the competent department of health under the State Council.
Article 88 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions are prohibited from giving or receiving kickbacks or other illegitimate interests in the purchase and sale of drugs.
It is prohibited for holders of drug marketing licenses, drug producing enterprises, drug handling enterprises or agents to give money, property or other illegitimate interests to the responsible persons, drug purchasers, physicians, pharmacists and other relevant personnel of the medical institutions using their drugs in any name.Persons in charge of medical institutions, drug purchasers, physicians, pharmacists and other relevant personnel are prohibited from accepting property or other illegitimate benefits from holders of drug marketing licenses, drug producing enterprises, drug handling enterprises or agents in any name.
Article 89 Drug advertising shall be approved by the advertising examination organ designated by the people's government of the province, autonomous region or municipality directly under the Central Government where the advertiser is located;Those without approval shall not be released.
Article 90 The contents of a drug advertisement shall be true and lawful, and shall be subject to the drug directions approved by the drug regulatory department under the State Council, and shall not contain false contents.
Drug advertisements shall not contain assertions or guarantees of efficacy or safety;It is not allowed to use the name or image of state organs, scientific research institutions, academic institutions, trade associations or experts, scholars, doctors, pharmacists, patients, etc. as a recommendation or certification.
Non drug advertisements shall not involve drug publicity.
Article 91 The provisions of the Price Law of the People's Republic of China, the Anti monopoly Law of the People's Republic of China, the Anti Unfair Competition Law of the People's Republic of China, and the Advertising Law of the People's Republic of China shall apply to drug prices and advertisements that are not stipulated in this law.
Chapter IX Drug Reserve and Supply
Article 92 The State implements a drug reserve system and establishes drug reserves at the central and local levels.
In the event of a major disaster, epidemic situation or other emergencies, drugs may be urgently used in accordance with the provisions of the Emergency Response Law of the People's Republic of China.
Article 93 The State implements the system of essential drugs, selects an appropriate number of essential drugs, strengthens the organization of production and storage, improves the supply capacity of essential drugs, and meets the demand for basic drugs for disease prevention and control.
Article 94 The State shall establish a drug supply and demand monitoring system, collect, summarize and analyze information on the supply and demand of drugs in short supply in a timely manner, give early warning to drugs in short supply, and take countermeasures.
Article 95 The State implements a system of inventory control of drugs in short supply.The specific measures shall be formulated by the competent health department under the State Council in conjunction with the drug regulatory department under the State Council and other departments.
If the holder of a drug marketing license stops producing drugs in short supply, it shall report to the drug regulatory department under the State Council or the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with regulations.
Article 96 The State encourages the research, development and production of drugs in short supply, and gives priority to the review and approval of urgently needed drugs in short supply and new drugs for the prevention and treatment of major infectious diseases, rare diseases and other diseases.
Article 97 The State Council may restrict or prohibit the export of drugs in short supply.When necessary, the relevant departments of the State Council may take measures such as organizing production, price intervention and expanding imports to ensure the supply of drugs.
Holders of drug marketing licenses, drug producing enterprises and drug handling enterprises shall guarantee the production and supply of drugs in accordance with regulations.
Chapter X Supervision and Management
Article 98 The production (including preparation, the same below), sale and use of fake medicines and medicines of inferior quality are prohibited.
Under any of the following circumstances, it is a fake medicine:
（1） The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards;
（2） Pass a non drug off as a drug or pass another drug off as such a drug;
（3） Deteriorating drugs;
（4） The indications or functions indicated on the drug are beyond the specified scope.
Under any of the following circumstances, it is a drug of inferior quality:
（1） The content of drug ingredients does not meet the national drug standards;
（2） Contaminated drugs;
（3） Drugs that are not marked or whose validity period has been changed;
（4） Drugs without indicating or changing the product batch number;
（5） Drugs that have expired;
（6） Drugs that add preservatives and auxiliary materials without authorization;
（7） Other drugs that do not meet the drug standards.
It is prohibited to produce or import drugs without obtaining drug approval documents;It is prohibited to use APIs, packaging materials and containers that have not been reviewed and approved in accordance with regulations to produce drugs.
Article 99 The pharmaceutical supervisory and administrative department shall, in accordance with the provisions of laws and regulations, supervise and inspect the activities of pharmaceutical research, production, trade and the use of drugs by pharmaceutical users. When necessary, it may conduct extended inspections of the units and individuals that provide products or services for pharmaceutical research, production, trade and use, and the relevant units and individuals shall cooperate,No refusal or concealment is allowed.
Drug regulatory departments shall focus on the supervision and inspection of high-risk drugs.
If there is evidence to prove that there may be potential safety hazards, the drug regulatory department shall, according to the supervision and inspection, take such measures as warning, interview, rectification within a time limit, and suspension of production, sales, use, and import, and timely publish the inspection and handling results.
When conducting supervision and inspection, pharmaceutical supervisory and administrative departments shall produce supporting documents and keep confidential the trade secrets they have learned during supervision and inspection.
Article 100 Pharmaceutical supervisory and administrative departments may, according to the needs of supervision and administration, conduct spot checks on the quality of pharmaceuticals.Sampling inspection shall be carried out in accordance with regulations and no fees shall be charged;Samples shall be purchased for sampling.The necessary expenses shall be disbursed in accordance with the provisions of the State Council.
The drug regulatory department may seal up and detain the drugs and related materials that have evidence to prove that they may endanger human health, and make an administrative decision within seven days;If a drug needs to be inspected, an administrative decision shall be made within 15 days after the inspection report is issued.
Article 101 The drug regulatory departments of the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall regularly publish the results of the random inspection of drug quality;If the announcement is improper, it shall be corrected within the scope of the original announcement.
Article 102 If the party concerned disagrees with the results of drug inspection, it may, within seven days from the date of receiving the results of drug inspection, apply for re inspection to the original drug inspection institution or the drug inspection institution established or designated by the drug regulatory department at the next higher level, or directly apply for re inspection to the drug inspection institution established or designated by the drug regulatory department of the State Council.The drug inspection institution that accepts the re inspection shall make a conclusion on the re inspection within the time specified by the drug regulatory department under the State Council.
Article 103 Pharmaceutical supervisory and administrative departments shall abide by the GMP, GMPCheck the drug clinical trial quality management specifications and supervise their continuous compliance with legal requirements.
Article 104 The State establishes a professional and specialized team of drug inspectors.Inspectors shall be familiar with drug laws and regulations and have professional knowledge of drugs.
Article 105 The drug regulatory department shall establish drug safety credit files for the holders of drug marketing licenses, drug manufacturing enterprises, drug trading enterprises, drug non clinical safety evaluation and research institutions, drug clinical testing institutions and medical institutions, and record the licensing, daily supervision and inspection results, investigation and punishment of illegal acts, etc,Announce to the public according to law and update in time;For those with bad credit records, the frequency of supervision and inspection shall be increased, and joint punishment may be implemented according to national regulations.
Article 106 The drug regulatory department shall publish its e-mail address and telephone number, accept inquiries, complaints and reports, and timely reply, verify and deal with them according to law.If the report is verified to be true, the reporter shall be rewarded in accordance with relevant regulations.
The drug regulatory department shall keep confidential the information of the informant and protect the legitimate rights and interests of the informant.If the informant reports to his unit, the unit shall not retaliate against the informant by canceling or changing the labor contract or by other means.
Article 107 The State implements a system of unified publication of drug safety information.The general situation of the country's drug safety, drug safety risk warning information, major drug safety incidents and their investigation and handling information, and other information determined by the State Council to be uniformly announced shall be uniformly announced by the drug regulatory department under the State Council.Drug safety risk warning information, major drug safety incidents and their investigation and handling information may also be published by the drug regulatory department of the people's government of the relevant province, autonomous region, or municipality directly under the Central Government if their impact is limited to specific regions.The above information shall not be released without authorization.
The publication of drug safety information shall be timely, accurate and comprehensive, and necessary explanations shall be made to avoid misleading.
No unit or individual may fabricate or disseminate false drug safety information.
Article 108 People's governments at or above the county level shall formulate emergency plans for drug safety incidents.Pharmaceutical marketing license holders, pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises and medical institutions shall formulate their own disposal plans for pharmaceutical safety incidents, and organize training and emergency drills.
In case of a drug safety incident, the people's government at or above the county level shall immediately organize and carry out the response work in accordance with the emergency plan;The relevant units shall immediately take effective measures to deal with the situation and prevent the harm from spreading.
Article 109 If the drug regulatory department fails to discover the systemic risks of drug safety in time and eliminate the hidden dangers of drug safety in the supervision and administration area in time, the people's government at the same level or the drug regulatory department of the people's government at a higher level shall interview its main responsible person.
If the local people's government fails to perform its drug safety duties and eliminate major regional drug safety hazards in a timely manner, the people's government at a higher level or the drug regulatory department of the people's government at a higher level shall interview its main responsible person.
The department interviewed and the local people's government shall immediately take measures to rectify the drug supervision and administration.
The interview and rectification shall be included in the review and assessment records of the drug supervision and administration work of the relevant departments and local people's governments.
Article 110 The local people's government and its drug regulatory department shall not restrict or exclude the entry of drugs produced by non local drug marketing license holders or drug manufacturing enterprises into the region by means of requiring drug inspection, approval or other means.
Article 111 Pharmaceutical supervisory and administrative departments and their established or designated pharmaceutical professional and technical institutions shall not participate in pharmaceutical production and marketing activities, and shall not recommend or supervise the production and marketing of pharmaceuticals in their names.
Staff members of drug regulatory departments and their established or designated pharmaceutical professional technical institutions may not participate in drug production and marketing activities.
Article 112 Where the State Council has other special regulations on narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals, etc., such regulations shall prevail.
Article 113 If a drug regulatory department finds that an illegal drug act is suspected of committing a crime, it shall promptly transfer the case to the public security organ.
For those who do not need to be investigated for criminal responsibility or exempted from criminal punishment according to law, but should be investigated for administrative responsibility, the public security organ, the People's Procuratorate, and the People's Court shall promptly transfer the case to the drug regulatory department.
If the public security organ, the People's Procuratorate, the People's Court consult with the drug regulatory department, the competent ecological environment department and other departments to provide inspection conclusions, confirmation opinions, harmless treatment of the drugs involved and other assistance, the relevant departments shall provide timely assistance.
Chapter XI Legal Liability
Article 114 Anyone who violates the provisions of this Law and constitutes a crime shall be investigated for criminal responsibility according to law.
Article 115 Anyone who produces or sells drugs without obtaining a drug production license, drug trade license or pharmaceutical preparation license of a medical institution shall be ordered to close down, the drugs illegally produced or sold and the illegal income shall be confiscated, and a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced or sold (including the drugs already sold or unsold, the same below) shall be imposed;If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan.
Article 116 Those who produce or sell fake drugs shall have their illegally produced or sold drugs and illegal income confiscated, be ordered to stop production or business for rectification, have their drug approval documents revoked, and be fined not less than 15 times but not more than 30 times the value of the drugs illegally produced or sold;If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan;If the circumstances are serious, the drug production license, drug trade license or pharmaceutical preparation license of a medical institution shall be revoked, and the corresponding application shall not be accepted within ten years;If the holder of the drug marketing license is an overseas enterprise, the drug import shall be prohibited within ten years.
Article 117 Where inferior drugs are produced or sold, the drugs illegally produced or sold and the illegal income therefrom shall be confiscated, and a fine of not less than 10 times but not more than 20 times the value of the drugs illegally produced or sold shall be imposed;If the value of drugs illegally produced or wholesale is less than 100000 yuan, it shall be calculated as 100000 yuan; if the value of drugs illegally retailed is less than 10000 yuan, it shall be calculated as 10000 yuan;If the circumstances are serious, the company shall be ordered to suspend production or business for rectification, or even revoke the drug approval certificate, drug production license, drug trade license or pharmaceutical preparation license of medical institutions.
If the prepared slices of traditional Chinese medicine produced and sold do not meet the drug standards, but do not affect the safety and effectiveness, they shall be ordered to correct within a time limit and given a warning;May be fined not less than 100000 yuan but not more than 500000 yuan.
Article 118 If anyone produces or sells fake medicines or medicines of inferior quality and the circumstances are serious, the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be confiscated of the income they have earned from their own unit during the period when the violation occurred, and a fine of not less than 30 percent but not more than three times the income they have received shall be imposed, and drug production and marketing activities shall be prohibited for life,The public security organ may also impose a detention of not less than five days but not more than 15 days.
The raw materials, auxiliary materials, packaging materials and production equipment specially used by producers to produce fake and substandard drugs shall be confiscated.
Article 119 Drug users who use fake drugs or drugs of inferior quality shall be punished in accordance with the provisions on the sale of fake drugs or the retail sale of drugs of inferior quality;If the circumstances are serious, the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons who have medical and health personnel practice certificates shall also have their practice certificates revoked.
Article 120 If anyone knows or should know that a drug is fake, substandard or a drug specified in Items 1 to 5 of the first paragraph of Article 124 of this Law, and provides convenient conditions for its storage and transportation, all of its storage and transportation income shall be confiscated, and a fine of not less than one time but not more than five times the illegal income shall also be imposed;If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal income shall also be imposed;If the illegal income is less than 50000 yuan, it shall be calculated as 50000 yuan.
Article 121 The decision on punishment for fake or substandard drugs shall, in accordance with law, state the conclusion of the quality inspection of the drug inspection institution.
Article 122 Anyone who forges, alters, leases, lends or illegally trades in licenses or drug approval documents shall have his illegal income confiscated and be fined not less than one time but not more than five times his illegal income;If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal gains shall also be imposed, the drug production license, drug trade license, pharmaceutical preparation license of medical institutions or drug approval documents shall be revoked, and the legal representative, main responsible person, directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan,It is prohibited to engage in drug production and marketing activities for ten years, and may be detained by the public security organ for not less than five days but not more than 15 days;If the illegal income is less than 100000 yuan, it shall be calculated as 100000 yuan.
Article 123 Those who provide false certificates, data, materials, samples or take other means to defraud clinical trial licenses, drug production licenses, drug trade licenses, pharmaceutical preparation licenses of medical institutions or drug registration and other licenses shall revoke the relevant licenses, ignore their corresponding applications within 10 years, and be fined between 500000 yuan and 5 million yuan;If the circumstances are serious, the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan, and drug production and marketing activities shall be prohibited for ten years, and the public security organ may detain them for not less than five days but not more than 15 days.
Article 124 Whoever, in violation of the provisions of this Law, commits one of the following acts shall have his unlawfully produced, imported or sold drugs and illegal income, as well as raw materials, auxiliary materials, packaging materials and production equipment specially used for illegal production confiscated, be ordered to suspend production or business for rectification, and be concurrently fined not less than 15 times but not more than 30 times the value of the drugs unlawfully produced, imported or sold;If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan;If the circumstances are serious, the drug approval certificate shall be revoked, or even the drug production license, drug trade license or pharmaceutical preparation license of a medical institution shall be revoked. The legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be confiscated of their income during the period when the illegal act occurred, and a fine of not less than 30% but not more than three times the income shall be imposed,It is forbidden to engage in drug production and marketing activities for ten years or even for life, and may be detained by the public security organ for not less than five days but not more than 15 days:
（1） Manufacturing and importing drugs without obtaining drug approval documents;
（2） Produce and import drugs using the drug approval certificate obtained by deception;
（3） Using raw materials that have not been reviewed and approved to produce drugs;
（4） Sales of drugs that should be inspected without inspection;
（5） Producing and selling drugs prohibited by the drug regulatory department under the State Council;
（6） Compile production and inspection records;
（7） Make major changes during drug production without approval.
If a drug user sells the drugs specified in items 1 to 3 of the preceding paragraph or uses the drugs specified in items 1 to 5 of the preceding paragraph, he shall be punished in accordance with the provisions of the preceding paragraph;If the circumstances are serious, the legal representative, principal responsible person, directly responsible person in charge and other responsible persons of the drug using unit who have medical and health personnel practice certificates shall also have their practice certificates revoked.
If a small amount of drugs that have been legally listed abroad are imported without approval and the circumstances are relatively minor, they may be mitigated or exempted from punishment according to law.
Article 125 Whoever, in violation of the provisions of this Law, commits one of the following acts shall have his unlawfully produced and sold drugs and illegal income as well as packaging materials and containers confiscated, be ordered to stop production and business for rectification, and be concurrently fined not less than 500000 yuan but not more than 5 million yuan;If the circumstances are serious, the drug approval certificate, drug production license and drug trade license shall be revoked, and the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan, and the drug production and trade activities shall be banned for ten years or even for life:
（1） Conducting drug clinical trials without approval;
（2） Use packaging materials or containers that have not been reviewed and are in direct contact with drugs to produce drugs, or sell such drugs;
（3） Use unapproved labels and instructions.
Article 126 Except as otherwise provided for in this Law, holders of drug marketing licenses, drug producing enterprises, drug handling enterprises, drug non clinical safety evaluation and research institutions, drug clinical trial institutions, etc., fail to comply with the quality control standards for drug production, drug handling and drug non clinical researchIf the quality control standards for drug clinical trials are met, they shall be ordered to make corrections within a time limit and given a warning;If it fails to make corrections within the time limit, it shall be fined not less than 100000 yuan but not more than 500000 yuan;If the circumstances are serious, a fine of not less than 500000 yuan but not more than 2 million yuan will be imposed, and the company will be ordered to suspend production and business for rectification, or even revoke the drug approval certificate, drug production license, drug trading license, etc. The drug non clinical safety evaluation and research institutions, drug clinical trial institutions, etc. will not carry out drug non clinical safety evaluation and research, drug clinical trials within five years,The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons shall be confiscated of the income obtained from the unit during the period of the illegal act, and a fine of 10% to 50% of the income shall be imposed, and the drug production and marketing activities shall be prohibited for ten years or even for life.
Article 127 Whoever, in violation of the provisions of this Law, commits one of the following acts shall be ordered to make corrections within a time limit and given a warning;If it fails to make corrections within the time limit, it shall be fined not less than 100000 yuan but not more than 500000 yuan:
（1） The bioequivalence test was not filed;
（2） During the clinical trial of drugs, if safety problems or other risks are found, the clinical trial sponsor fails to timely adjust the clinical trial scheme, suspend or terminate the clinical trial, or fails to report to the drug regulatory department under the State Council;
（3） Failing to establish and implement a drug traceability system as required;
（4） Failing to submit the annual report as required;
（5） Failing to record or report changes in the process of drug production as required;
（6） No post marketing risk management plan has been formulated;
（7） Failure to carry out post marketing research or post marketing evaluation of drugs in accordance with regulations.
Article 128 In addition to the penalties that should be imposed on fake or substandard drugs according to law, if the drug package does not have labels or instructions printed or affixed in accordance with the regulations, and if the labels or instructions do not indicate relevant information or have specified marks, the drug packaging unit shall be ordered to make corrections and be given a warning;If the circumstances are serious, the drug registration certificate shall be revoked.
Article 129 Anyone who, in violation of the provisions of this Law, fails to purchase drugs from the holder of the drug marketing license or from an enterprise qualified for drug production or marketing, the holder of the drug marketing license, the drug producing enterprise, the drug handling enterprise or the medical institution shall be ordered to make corrections, and the illegally purchased drugs and the illegal income shall be confiscated,It shall also impose a fine of not less than two times but not more than ten times the value of the illegally purchased drugs;If the circumstances are serious, a fine of not less than 10 times but not more than 30 times the value of the goods shall also be imposed, and the drug approval certificate, drug production license, drug trade license or medical institution practice license shall be revoked;If the value of goods is less than 50000 yuan, it shall be calculated as 50000 yuan.
Article 130 If a drug handling enterprise, in violation of the provisions of this Law, fails to keep records of the purchase and sale of drugs in accordance with the provisions, fails to correctly explain the usage, dosage and other matters of retail drugs, or fails to dispense prescriptions in accordance with the provisions, it shall be ordered to make corrections and be given a warning;If the circumstances are serious, the drug trade license shall be revoked.
Article 131 If a third-party platform provider of drug online trading fails to perform its obligations of qualification examination, report, and stop providing online trading platform services in violation of the provisions of this Law, it shall be ordered to make corrections, its illegal income shall be confiscated, and it shall also be fined not less than 200000 yuan but not more than 2 million yuan;If the circumstances are serious, it shall be ordered to suspend business for rectification and shall be fined not less than 2 million yuan but not more than 5 million yuan.
Article 132 Those who import drugs for which drug registration certificates have been obtained but fail to file with the drug regulatory department of the place where the port where the drugs are allowed to be imported according to regulations, shall be ordered to make corrections within a time limit and given a warning;If it fails to make corrections within the time limit, its drug registration certificate shall be revoked.
Article 133 If a medical institution, in violation of the provisions of this Law, sells its preparations on the market, it shall be ordered to make corrections, the preparations illegally sold and the illegal income shall be confiscated, and a fine of not less than two times but not more than five times the value of the preparations illegally sold shall be imposed;If the circumstances are serious, a fine of not less than five times but not more than fifteen times the value of the goods shall also be imposed;If the value of goods is less than 50000 yuan, it shall be calculated as 50000 yuan.
Article 134 If a holder of a drug marketing license fails to monitor adverse drug reactions or report suspected adverse drug reactions in accordance with the provisions, he shall be ordered to make corrections within a time limit and given a warning;If it fails to make corrections within the time limit, it shall be ordered to suspend production and business for rectification, and shall be fined not less than 100000 yuan but not more than one million yuan.
If a drug handling enterprise fails to report suspected adverse drug reactions according to regulations, it shall be ordered to make corrections within a time limit and be given a warning;If it fails to make corrections within the time limit, it shall be ordered to suspend production and business for rectification, and shall be fined not less than 50000 yuan but not more than 500000 yuan.
If a medical institution fails to report the suspected adverse drug reactions according to the regulations, it shall be ordered to make corrections within a time limit and be given a warning;If it fails to make corrections within the time limit, it shall be fined not less than 50000 yuan but not more than 500000 yuan.
Article 135 If the holder of a drug marketing license refuses to recall the drug after being ordered to do so by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, he shall be fined not less than five times but not more than ten times the value of the drug to be recalled;If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan;If the circumstances are serious, the drug approval certificate, drug production license and drug trade license shall be revoked, and the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan.If a drug producing enterprise, drug handling enterprise or medical institution refuses to cooperate with the recall, it shall be fined not less than 100000 yuan but not more than 500000 yuan.
Article 136 If the holder of the drug marketing license is an overseas enterprise, and the designated enterprise legal person in China fails to perform the relevant obligations in accordance with the provisions of this Law, the provisions of this Law on the legal liability of the holder of the drug marketing license shall apply.
Article 137 Whoever commits one of the following acts shall be given a heavier punishment within the range of punishment prescribed in this Law:
（1） To pass off narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, drug like precursor chemicals as other drugs, or pass off other drugs as the above drugs;
（2） Produce and sell fake and substandard drugs mainly used by pregnant women and children;
（3） The biological products produced and sold belong to fake medicines and inferior medicines;
（4） Production and sales of fake and substandard drugs, resulting in personal injury consequences;
（5） Produce and sell fake and substandard drugs, and commit again after treatment;
（6） Refusing or evading supervision and inspection, forging, destroying or hiding relevant evidence materials, or using sealed up or detained articles without authorization.
Article 138 If a drug inspection institution issues a false inspection report, it shall be ordered to make corrections, given a warning, and fined not less than 200000 yuan but not more than 1 million yuan;The directly responsible person in charge and other directly responsible persons shall be demoted, dismissed or dismissed according to law, their illegal gains shall be confiscated, and they shall also be fined not more than 50000 yuan;If the circumstances are serious, the inspection qualification shall be revoked.If the inspection results issued by a drug inspection institution are untrue and cause losses, it shall bear the corresponding liability for compensation.
Article 139 The administrative penalty provided for in Articles 115 to 138 of this Law shall be decided by the drug regulatory department of the people's government at or above the county level according to the division of responsibilities;The revocation of a permit or a permit shall be decided by the department that originally approved or issued the permit.
Article 140 Where a holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or a medical institution employs personnel in violation of the provisions of this Law, the drug regulatory department or the competent health department shall order him to dismiss and impose a fine of not less than 50000 yuan but not more than 200000 yuan.
Article 141 Where a holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or a medical institution gives or receives kickbacks or other illegitimate interests in the purchase and sale of drugs, the holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or its agent gives or accepts kickbacks or other illegitimate interests to the person in charge, drug purchasers, physiciansWhere the property or other illegitimate interests of pharmacists and other relevant personnel are involved, the market supervision and administration department shall confiscate the illegal gains and impose a fine of not less than 300000 yuan but not more than 3 million yuan;If the circumstances are serious, the holder of the drug marketing license, the business license of the drug producing enterprise or the drug handling enterprise shall be revoked, and the drug regulatory department shall revoke the drug approval certificate, the drug production license or the drug handling license.
If a holder of a drug marketing license, a drug producing enterprise or a drug trading enterprise offers bribes to a state functionary in the course of drug research, production or trading, the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons shall be prohibited from engaging in drug production or trading activities for life.
Article 142 Where a holder of a drug marketing license, a person in charge of a drug producing enterprise, a drug handling enterprise, a purchaser or other relevant personnel accepts money, property or other illegitimate interests from another holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or an agent in the purchase and sale of drugs, their illegal income shall be confiscated and they shall be punished according to law;If the circumstances are serious, drug production and marketing activities shall be prohibited for five years.
If the responsible person, drug purchaser, physician, pharmacist and other relevant personnel of a medical institution accept property or other illegitimate interests from the holder of the drug marketing license, drug manufacturing enterprise, drug handling enterprise or agent, the competent health department or the unit shall give them sanctions and confiscate their illegal income;If the circumstances are serious, his practice certificate shall also be revoked.
Article 143 Whoever, in violation of the provisions of this Law, fabricates or disseminates false drug safety information, which constitutes a violation of the administration of public security, shall be given a public security administration punishment by the public security organ according to law.
Article 144 Where a holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or a medical institution violates the provisions of this Law and causes damage to the drug user, it shall bear the liability for compensation according to law.
If the damage is caused by the quality problem of a drug, the victim may claim compensation from the holder of the drug marketing license or the drug manufacturing enterprise, or from the drug trading enterprise or medical institution.If a claim for compensation is received from the victim, the first responsibility system shall be implemented and compensation shall be paid first;After compensation is made in advance, compensation can be recovered according to law.
Where fake medicines or medicines of inferior quality are produced or are still sold or used while clearly knowing that they are fake medicines or medicines of inferior quality, the victim or his close relatives may, in addition to claiming compensation for the losses, also claim compensation of ten times the price or three times the losses;If the amount of additional compensation is less than 1000 yuan, it shall be 1000 yuan.
Article 145 If a pharmaceutical supervisory and administrative department or a pharmaceutical professional technical institution set up or designated by it participates in pharmaceutical production and marketing activities, its superior competent authority shall order it to make corrections and confiscate its illegal income;If the circumstances are serious, the persons directly in charge and other persons directly responsible shall be given sanctions according to law.
Any staff member of a pharmaceutical supervisory and administrative department or of a pharmaceutical professional technical institution set up or designated by it who participates in pharmaceutical production and marketing activities shall be given a sanction according to law.
Article 146 If a drug regulatory department or a drug inspection institution set up or designated by it illegally collects inspection fees during drug supervision and inspection, the relevant government departments shall order it to return the fees, and the directly responsible person in charge and other directly responsible persons shall be punished according to law;If the circumstances are serious, the inspection qualification shall be revoked.
Article 147 If a drug regulatory department, in violation of the provisions of this law, commits one of the following acts, it shall revoke the relevant license, and the directly responsible person in charge and other directly responsible persons shall be punished according to law:
（1） Approval of drug clinical trials if the conditions are not met;
（2） Issue drug registration certificates to unqualified drugs;
（3） A pharmaceutical production license, a pharmaceutical trading license or a pharmaceutical preparation license for a medical institution shall be issued to a unit that does not meet the requirements.
Article 148 Where a local people's government at or above the county level, in violation of the provisions of this Law, commits one of the following acts, the person directly in charge and the other persons directly responsible shall be given a sanction of recording a demerit or a major demerit;If the circumstances are serious, they shall be demoted, dismissed or dismissed:
（1） Concealed, false, delayed or omitted drug safety incidents;
（2） Failing to eliminate major regional potential drug safety hazards in a timely manner, resulting in particularly serious drug safety incidents within the administrative region, or continuous major drug safety incidents;
（3） Inadequate performance of duties, resulting in serious adverse effects or heavy losses.
Article 149 If a drug regulatory department, in violation of the provisions of this law, commits one of the following acts, the directly responsible person in charge and other directly responsible persons shall be given a sanction of recording a demerit or a major demerit;If the circumstances are relatively serious, they shall be demoted or removed from office;If the circumstances are serious, they shall be dismissed:
（1） Concealed, false, delayed or omitted drug safety incidents;
（2） Failing to investigate and deal with drug safety violations found in a timely manner;
（3） Failing to discover systemic risks of drug safety in a timely manner, or failing to eliminate hidden dangers of drug safety in the supervision and management area in a timely manner, resulting in serious impact;
（4） Other failures to perform drug supervision and management duties, resulting in serious adverse effects or heavy losses.
Article 150 Pharmaceutical supervisory and administrative personnel who abuse their power, engage in malpractices for personal gain, or neglect their duties shall be punished according to law.
In case of dereliction of duty or dereliction of duty in investigating and dealing with illegal acts of counterfeit or substandard drugs, the persons directly in charge of the drug regulatory department and other persons directly responsible shall be given heavier punishment according to law.
Article 151 The value of goods specified in this Chapter shall be calculated on the basis of the marked price of drugs illegally produced or sold;If there is no marked price, it shall be calculated according to the market price of similar drugs.
Chapter XII Supplementary Provisions
Article 152 The cultivation, collection and breeding of Chinese medicinal materials shall be managed in accordance with the provisions of relevant laws and regulations.
Article 153 Measures for the control of local folk medicinal materials shall be formulated by the drug regulatory department under the State Council in conjunction with the department in charge of traditional Chinese medicine under the State Council.
Article 154 Specific measures for the implementation of this Law by the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be formulated by the State Council and the Central Military Commission in accordance with this Law.
Article 155 This Law shall come into force as of December 1, 2019.[3]
Content interpretation
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On August 26, 2019, the 12th meeting of the Standing Committee of the 13th National People's Congress closed in Beijing, and the meeting voted to pass the amendment to the Drug Administration Law of the People's Republic of China.The newly revised Drug Administration Law will come into force on December 1, 2019.This is the second systematic and structural major revision of the Drug Administration Law since its promulgation in 1984, which has turned the reform achievements and effective practices in the drug field into laws, providing more powerful legal protection for public health.
Summarize the achievements of reform, comprehensively and systematically revise
The Drug Administration Law is the basic law of drug supervision in China.The current Drug Administration Law was formulated in 1984, comprehensively revised for the first time in 2001, and partially revised in 2013 and 2015.The promulgation and implementation of the Drug Administration Law has played a huge role in standardizing drug production and operation activities, strengthening drug supervision and management, ensuring public drug safety, and promoting the development of the drug industry.However, with the development of the social economy and the pharmaceutical industry, there is a certain gap between the current Drug Administration Law and the new requirements of the CPC Central Committee and the State Council for drug safety, the new expectations of the people for drug safety, and the new situation faced by drug supervision and industrial development. There are not many measures to encourage innovation, and the punishment for illegal acts is not enough,Scientific supervision means are relatively backward.In order to adapt to the current new requirements, new expectations and new situations, further improve the drug safety governance system and enhance the drug safety governance capability, the 12th and 13th NPC Standing Committees incorporated the revision of the Drug Administration Law into the five-year legislative plan and accelerated the revision work.
In October 2018, the Drug Administration Law (Revised Draft) was submitted to the sixth meeting of the Standing Committee of the 13th National People's Congress for initial deliberation, and public opinions were solicited after the meeting.During the review, some comments were made that the current Drug Administration Law has not been greatly revised since its revision in 2001. It is suggested that the reform achievements and effective practices in the drug field over the years should be upgraded to law and the revised draft should be changed into the revised draft.In April 2019, the 10th meeting of the 13th NPC Standing Committee reviewed the Drug Administration Law (Revised Draft).On August 26, 2019, the 12th Meeting of the Standing Committee of the 13th National People's Congress deliberated for the third time and voted for approval.
The newly revised Drug Administration Law fully implements the "four strictest" requirements of the CPC Central Committee on drug safety, clarifies the drug management mission of protecting and promoting public health, establishes the basic principles of taking people's health as the center, adhering to risk management, full process control, and social governance, and requires the establishment of a scientific and strict supervision and management system to comprehensively improve drug quality,Ensure the safety, effectiveness and accessibility of drugs.These fully reflect the revision of the Drug Administration Law, adhering to the people-oriented, problem oriented, law respecting, international perspective, reform and innovation, and scientific development.
Encourage research and innovation to ensure supply accessibility
In August 2015, the State Council issued the Opinions on Reforming the Review and Approval System of Pharmaceutical and Medical Devices (GF [2015] No. 44). In October 2017, the Central Office and the State Office issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices (TZ [2017] No. 42), focusing on the five themes of "innovation, quality, efficiency, system, and capability",A series of historic and innovative major reform measures were proposed, such as encouraging drug R&D innovation, carrying out the pilot project of drug marketing license holder system, reforming clinical trial management, and speeding up the market review and approval.Over the past few years, the reform and innovation of drug regulation has been vigorously promoted and achieved remarkable results.The newly revised Drug Administration Law solidified the effective reform measures into legal achievements, encouraged the development and innovation of new drugs, and laid a more solid legal foundation for deepening the reform in the drug field.
Support clinical value oriented drug innovation with clear or special effects on human diseases.We will encourage the development of new drugs with new therapeutic mechanisms, treatment of diseases or rare diseases that are seriously life-threatening, and multi-target systemic regulation and intervention functions for the human body, and encourage the development and innovation of drugs for children.
Establish and improve the drug review and approval system.Improve the efficiency of review and approval and optimize the review and approval process through a series of measures.For example, establish systems for communication and expert consultation, change the approval system of clinical trials to the implied licensing system upon expiration, and implement the record management for bioequivalence trials and drug clinical trial institutions.
At the same time, priority shall be given to the review and approval of urgently needed drugs, new drugs for prevention and treatment of major infectious diseases, rare diseases and other diseases, and drugs for children;For the treatment of diseases that seriously endanger lives and have no effective treatment means, as well as drugs urgently needed in public health, they can be approved for marketing with conditions attached.
All sectors of the society pay close attention to the shortage of commonly used drugs and emergency (rush) drugs in China. The newly revised Drug Administration Law stipulates a special chapter on "drug storage and supply", which specifies that the country implements a drug storage system, establishes a drug supply and demand monitoring system, implements a list management system for drugs in short supply, and implements a priority review system for drugs in short supply,Multi departments work together to strengthen drug supply security.
Adhere to the whole process control and implement the responsibilities of all parties
Drug safety is related to public life and health. On the basis of carefully summarizing the international drug management experience, the newly revised Drug Administration Law further clarifies that drug safety work should follow the basic principles of "risk management, full process control, and social governance", and take the implementation of the drug marketing license holder system as the main line,Further clarify the quality and safety responsibilities throughout the life cycle of drugs, and firmly hold the bottom line of public safety.
The holder of the drug marketing license shall be responsible for the drug safety, effectiveness and quality reliability in the whole process of drug development, production, marketing and use according to law.The newly revised "Drug Administration Law" has set up Chapter III "Drug Marketing License Holders", which comprehensively and systematically stipulates the conditions, rights, obligations and responsibilities of the holders.
The newly revised Drug Administration Law strengthens the information requirements of the whole process of drugs.To engage in drug research, production, marketing and use activities, laws, regulations, rules, standards and specifications shall be followed to ensure that the information in the whole process is true, accurate, complete and traceable.
The newly revised Drug Administration Law also strictly controls the links of drug development, production and circulation.It is stipulated that engaging in drug development shall comply with the quality management standards for non clinical drug research and drug clinical trials, and ensure that the whole process of drug development continues to meet legal requirements.It stipulates that the holders shall establish a drug quality assurance system and strictly control the release of drugs on the market.The holder shall comprehensively evaluate and verify the impact of the changed items on the drug safety, effectiveness and quality controllability in accordance with national regulations.At the same time, the holder shall establish and implement a traceability system to ensure the traceability of drugs.
The newly revised Drug Administration Law also puts forward clear requirements for post marketing management of drugs.It is required to establish an annual reporting system, and the holders shall report the production and sales of drugs, post marketing research, risk management and other information to the drug regulatory authorities in accordance with the regulations every year.At the same time, the holder shall actively carry out post marketing research on drugs, further verify the safety, effectiveness and quality controllability of drugs, and take risk control measures for drugs with identified risks in a timely manner.If damage is caused to the drug users, they shall be liable for compensation according to law.
In addition, the newly revised Drug Administration Law also strengthened the implementation of the concept of full life cycle management of drugs from aspects of drug vigilance, supervision and inspection, credit management, emergency disposal, etc., refined and improved the treatment measures of drug regulatory authorities, and improved the regulatory effectiveness.
This revision also strengthened the concept of "social co governance" of drug safety, strengthened the responsibilities of local governments, relevant departments, drug industry associations, news media and other aspects, and worked together to ensure drug safety.
Strictly punish and severely punish those who violate the law
The newly revised "Drug Administration Law" comprehensively increased the punishment for illegal acts, and specifically stipulated that those who violate the provisions of this law and constitute a crime shall be investigated for criminal responsibility according to law, and clearly maintain a high pressure on drug safety crimes.
The range of property penalties has been increased.For illegal acts such as unlicensed production and operation, production and sales of counterfeit drugs, the amount of fines will increase from two to five times the value of the goods to fifteen to thirty times. If the value of the goods is less than 100000 yuan, the amount of fines will be 100000 yuan, which is the minimum fine of 1.5 million yuan.The fines for illegal acts of producing and selling substandard drugs have also increased from one to three times the value of the goods to ten to twenty times.
The qualification punishment was strengthened.The qualification punishment of the person responsible for the illegal act of fake and substandard drugs has been raised from a 10-year ban to a lifelong ban. For enterprises whose licenses for producing and selling fake drugs have been revoked, their corresponding applications will not be accepted within 10 years.
Added the means of free punishment.If the circumstances of producing and selling fake drugs and producing and selling inferior drugs are serious, as well as the illegal acts such as forging and fabricating licenses and obtaining licenses by fraud, the public security organ may detain the relevant responsible persons for five to fifteen days.
For enterprises that have seriously violated the law, the newly revised Drug Administration Law implements the principle of "punishing individuals". While punishing enterprises according to law, the legal representatives, main responsible persons, directly responsible executives and other responsible persons of enterprises will also be punished, including confiscation of their income during the illegal act, fines, a certain period of time or even lifetime prohibition.
The newly revised Drug Administration Law also improved the civil liability system.Including clarifying the compensation liability of drug marketing license holders and drug manufacturing and trading enterprises;To stipulate that the agent of the holder of the overseas drug marketing license in China shall bear joint and several liabilities with the holder;Implement the first responsibility system for civil compensation;Where fake and inferior medicines are produced or sold and used with the knowledge that they are still fake and inferior medicines, the victim may demand punitive compensation, etc.
When significantly improving the punishment for illegal acts, the newly revised Drug Administration Law strictly implements the principle of "equal punishment for excessive acts", distinguishes between ordinary illegal acts and serious illegal acts that cause serious consequences, and focuses on increasing the punishment for subjective intent or serious illegal acts.[4]
