People's Republic of China Drug Administration Law

(Adopted at the 7th meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and revised at the 20th meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001, according to December 28, 2013 The Decision of the Sixth Session of the Standing Committee of the 12th National People's Congress on the Amendment of the Seven Laws of the People's Republic of China on Marine Environmental Protection Law, and the Standing of the Twelfth National People's Congress on April 24, 2015 At its fourteenth meeting, the Committee adopted a decision to amend the Drug Administration Law of the People's Republic of China.

 

 

 

Chapter 1 General

 

  Article 1 This Law is enacted for the purpose of strengthening drug supervision and management, ensuring the quality of drugs, ensuring the safety of human drugs, and safeguarding the people's health and the legitimate rights and interests of drugs.

 

  Article 2 Units or individuals engaged in the research, production, operation, use, supervision and administration of drugs within the territory of the People's Republic of China must abide by this Law.

 

  Article 3 The State develops modern medicines and traditional medicines and gives full play to its role in prevention, medical care and health care. The state protects wild medicinal materials and encourages the cultivation of Chinese medicinal materials.

 

  Article 4 The State encourages the research and creation of new drugs to protect the legitimate rights and interests of citizens, legal persons and other organizations in researching and developing new drugs.

 

  Article 5 The drug regulatory department of the State Council shall be in charge of the national drug supervision and administration work. The relevant departments of the State Council are responsible for the supervision and administration of drugs in their respective areas of responsibility. The drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government shall be responsible for drug supervision and administration within its administrative region. The relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of drugs in their respective areas of responsibility. The drug regulatory department of the State Council shall cooperate with the competent economic department of the State Council to implement the development plan and industrial policy of the pharmaceutical industry formulated by the State.

 

  Article 6 The drug inspection agency set up or determined by the drug supervision and administration department shall undertake the drug inspection work required for drug approval and drug quality supervision and inspection according to law.

 

 

 

Chapter II Administration of Pharmaceutical Production Enterprises

 

  Article 7 The establishment of a pharmaceutical production enterprise shall be approved by the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government and issued to the Pharmaceutical Production License. If there is no "Production License", no drugs may be produced. The Pharmaceutical Production License shall indicate the validity period and production scope, and re-examine and issue the certificate upon expiration. The drug regulatory authority approves the establishment of a pharmaceutical production enterprise. In addition to the conditions stipulated in Article 8 of this Law, it shall also comply with the development plan and industrial policy of the pharmaceutical industry formulated by the State to prevent redundant construction.

 

  Article 8 To start a pharmaceutical production enterprise, the following conditions must be met:

 

  (1) Pharmacy technicians, engineering and technical personnel and corresponding skilled workers who have been qualified according to law;

 

  (2) having a plant, facility and sanitary environment compatible with its pharmaceutical production;

 

  (3) having institutions, personnel and necessary equipment and equipment capable of quality management and quality inspection of the produced drugs;

 

  (4) Rules and regulations that guarantee the quality of drugs.

 

  Article 9 A pharmaceutical production enterprise must organize production in accordance with the "Good Manufacturing Practices for Pharmaceutical Production" formulated by the drug regulatory authority under the State Council in accordance with this Law. The drug supervision and administration department shall, in accordance with the regulations, certify whether the drug production enterprise meets the requirements of the "Good Manufacturing Practices"; if it is qualified, it shall issue a certificate. The specific implementation methods and implementation steps of the "Good Manufacturing Practices" are prescribed by the drug regulatory department of the State Council.

 

  Article 10 In addition to the processing of Chinese medicine decoction pieces, the drugs must be produced in accordance with the national drug standards and the production process approved by the drug regulatory authority under the State Council. The production records must be complete and accurate. If a pharmaceutical production enterprise changes the production process that affects the quality of the drug, it must report to the original approval department for review and approval. Chinese Herbal Pieces must be prepared in accordance with national drug standards; if there are no provisions in the national drug standards, they must be processed in accordance with the processing regulations formulated by the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. The processing regulations formulated by the drug regulatory authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be reported to the drug regulatory department of the State Council for the record.

 

  Article 11 The raw materials and auxiliary materials required for the production of pharmaceuticals must meet the medicinal requirements.

 

  Article 12 A pharmaceutical production enterprise must carry out quality inspection on the medicines it produces; if it does not conform to the national drug standards or is not manufactured in accordance with the regulations of Chinese medicine decoctions formulated by the drug regulatory authorities of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government, it shall not leave the factory.

 

  Article 13 With the approval of the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government, a pharmaceutical production enterprise may accept the commissioning of pharmaceutical products.

 

 

 

Chapter III Administration of Pharmaceutical Enterprises

 

  Article 14 The establishment of a pharmaceutical wholesale enterprise shall be approved by the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government and issued to the Pharmaceutical Business License; for the establishment of a pharmaceutical retail enterprise, it shall be subject to the local drug supervision and administration at or above the county level. The department approves and issues the Drug License. If there is no "Pharmaceutical Business License", no drugs may be operated. The Pharmaceutical Business License shall indicate the validity period and business scope, and re-examine and issue the certificate upon expiration. The drug regulatory authority shall approve the establishment of a pharmaceutical trading enterprise. In addition to the conditions stipulated in Article 15 of this Law, it shall also follow the principle of rational distribution and convenience for the purchase of drugs by the masses.

 

  Article 15 The following conditions must be met for the establishment of a pharmaceutical business enterprise:

 

  (1) Pharmacists and technicians who have been qualified according to law;

 

  (2) having a business place, equipment, storage facilities and a sanitary environment that are compatible with the drugs to be operated;

 

  (3) having a quality management organization or personnel that is compatible with the drugs being operated;

 

  (4) It has rules and regulations to guarantee the quality of the drugs it operates.

 

  Article 16 A pharmaceutical trading enterprise must operate drugs in accordance with the “Good Manufacturing Practices for Drugs” formulated by the drug regulatory authority under the State Council in accordance with this Law. The drug supervision and administration department shall, in accordance with the regulations, certify whether the drug business enterprise meets the requirements of the “Good Manufacturing Practices for Drug Administration”; if it is qualified, it shall issue a certificate. The specific implementation measures and implementation steps of the "Good Manufacturing Practices" are prescribed by the drug regulatory department of the State Council.

 

  Article 17 If a pharmaceutical business enterprise purchases drugs, it must establish and implement a purchase inspection and acceptance system, and verify the drug certification and other marks; if it does not meet the requirements, it may not be purchased.

 

  Article 18 A pharmaceutical business enterprise must have a true and complete record of purchase and sale of drugs purchased and sold. The purchase and sales records must indicate the generic name, dosage form, specification, batch number, expiration date, manufacturer, purchase (sales) unit, purchase (sales) quantity, purchase and sale price, purchase (sales) date of the drug, and the drug regulatory department of the State Council. Other content as specified.

 

  Article 19 Drug sales enterprises must accurately and accurately sell the drugs, and correctly explain the usage, dosage and precautions; the prescriptions must be checked, and the drugs listed in the prescriptions must not be altered or substituted. For prescriptions with incompatibility or overdose, the allocation should be refused; if necessary, the prescription should be corrected or re-signed by the prescribing physician. Pharmaceutical companies that sell Chinese herbal medicines must indicate the place of origin.

 

  Article 20 A pharmaceutical trading enterprise must formulate and implement a drug storage system and take necessary measures such as refrigeration, antifreeze, moisture proof, insect control, and rodent control to ensure the quality of drugs. The inspection system must be implemented for drug storage and delivery.

 

  Article 21 Chinese and Chinese medicines may be sold in the urban and rural market trade markets, unless otherwise stipulated by the State Council. The urban and rural market trade market may not sell drugs other than Chinese herbal medicines, but pharmaceutical retail enterprises holding the "Pharmaceutical Business License" may, within the prescribed scope, sell drugs other than Chinese herbal medicines in the urban and rural market trade market. The specific measures by the State Council.

 

 

 

Chapter IV Administration of Pharmacy in Medical Institutions

 

  Article 22 Medical institutions must be equipped with pharmacy technicians who have been qualified according to law. Non-pharmaceutical technicians may not directly engage in pharmaceutical technology work.

 

  Article 23 The preparation of preparations by medical institutions shall be subject to the examination and approval of the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government, and shall be issued by the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government, and issued to the Medical Device Preparation License. If there is no "medical institution preparation license", no preparations may be formulated. The Medical Device Preparation License shall indicate the expiration date and re-examine the issuance of the certificate upon expiration.

 

  Article 24 Medical institutions must have facilities, management systems, inspection instruments and sanitary conditions to ensure the quality of preparations.

 

  Article 25 The preparations formulated by medical institutions shall be those that are not in the market for clinical needs of the unit and must be approved by the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government. The formulated preparations must be tested for quality according to the regulations; if they are qualified, they should be used by the medical institution according to the doctor's prescription. Under special circumstances, the preparations formulated by medical institutions may be transferred between designated medical institutions after approval by the State Council or the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government. Preparations prepared by medical institutions shall not be sold in the market.

 

  Article 26 If a medical institution purchases drugs, it must establish and implement a purchase inspection and acceptance system to verify the drug certification and other marks; if it does not meet the requirements, it may not be purchased or used.

 

  Article 27 The dispensing of prescriptions by pharmacists in medical institutions must be checked and the drugs listed in the prescriptions may not be altered or substituted. For prescriptions with incompatibility or overdose, the allocation should be refused; if necessary, the prescription should be corrected or re-signed by the prescribing physician.

 

  Article 28 Medical institutions must formulate and implement drug storage systems, and take necessary measures such as refrigeration, antifreeze, moisture, insect, and rodent to ensure the quality of drugs.

 

 

 

Chapter V Drug Administration

 

  Article 29 In the development of new drugs, relevant materials and samples such as development methods, quality indicators, pharmacological and toxicological test results must be submitted in accordance with the provisions of the drug regulatory authority under the State Council, and only after approval by the drug regulatory authority under the State Council. Clinical Trials. The method for determining the qualification of a drug clinical trial institution shall be jointly formulated by the drug regulatory department of the State Council and the health administrative department of the State Council. The new drug that has completed the clinical trial and passed the examination and approval shall be approved by the drug regulatory department of the State Council and issued a new drug certificate.

 

  Article 30 The non-clinical safety evaluation research institutions and clinical trial institutions must separately implement the quality management norms for drug non-clinical research and the quality management specifications for drug clinical trials. The quality management norms for drug non-clinical research and the quality management regulations for drug clinical trials shall be formulated by the department determined by the State Council.

 

  Article 31 The production of new drugs or drugs with national standards shall be subject to the approval of the drug regulatory authority under the State Council and the drug approval number shall be issued; however, except for the production of Chinese herbal medicines and Chinese herbal medicines without the approval of the approval number management. The catalogue of Chinese herbal medicines and traditional Chinese medicine decoction pieces for the implementation of the approval number management shall be formulated by the drug regulatory department of the State Council in conjunction with the Chinese medicine administration department of the State Council. The pharmaceutical manufacturer can only produce the drug after obtaining the drug approval number.

 

  Article 32 Drugs must comply with national drug standards. Chinese Herbal Pieces are administered in accordance with the provisions of the second paragraph of Article 10 of this Law. The Pharmacopoeia of the People's Republic of China and the drug standard promulgated by the drug regulatory department of the State Council are national drug standards. The drug regulatory department of the State Council organizes the Pharmacopoeia Commission to be responsible for the formulation and revision of national drug standards. The drug inspection agency of the drug regulatory department of the State Council is responsible for the calibration of national drug standards and reference materials.

 

  Article 33 The drug regulatory department of the State Council shall organize pharmacy, medical and other technical personnel to review new drugs and re-evaluate drugs that have been approved for production.

 

  Article 34 A pharmaceutical production enterprise, a pharmaceutical trading enterprise or a medical institution must purchase medicines from enterprises that have the qualifications for the production and operation of pharmaceuticals; however, except for the purchase of Chinese herbal medicines that are not subject to the approval number management.

 

  Article 35 The State exercises special management over narcotic drugs, psychotropic drugs, medical toxic drugs and radioactive drugs. The management measures shall be formulated by the State Council.

 

  Article 36 The State implements a system for the protection of Chinese medicine varieties. Specific measures shall be formulated by the State Council.

 

  Article 37 The State implements a classification management system for prescription drugs and non-prescription drugs for drugs. Specific measures shall be formulated by the State Council.

 

  Article 38 It is forbidden to import medicines with ineffective curative effects, large adverse reactions or other causes that endanger human health.

 

  Article 39 The import of pharmaceuticals shall be subject to the examination and examination by the drug regulatory authority under the State Council. If it is confirmed by inspection that it meets the quality standards, it is safe and effective before it can be approved for import and issued a certificate for the registration of imported drugs. A small amount of medicines urgently needed by medical units or imported by individuals for personal use shall be subject to import procedures in accordance with relevant state regulations.

 

  Article 40 Drugs must be imported from the ports where drugs are allowed to be imported, and the enterprises that import drugs should register with the drug regulatory authorities at the port. The Customs shall release the "Imported Drugs Customs Clearance Form" issued by the drug supervision and administration department. If there is no Customs Clearance Form for Imported Drugs, the Customs shall not release it. The drug supervision and administration department at the port of the port shall notify the drug inspection agency to conduct random inspections on imported drugs in accordance with the provisions of the drug regulatory authority under the State Council, and collect inspection fees in accordance with the provisions of paragraph 2 of Article 41 of this Law. The port that allows the import of drugs shall be submitted by the drug regulatory department of the State Council in conjunction with the General Administration of Customs and submitted to the State Council for approval.

 

  Article 41 The drug regulatory department of the State Council shall, in the case of pre-sale or import of the following drugs, designate the drug inspection agency to conduct inspections; if the inspection fails, it shall not be sold or imported:

 

  (1) Biological products prescribed by the drug regulatory department of the State Council;

 

  (2) drugs first sold in China;

 

  (3) Other drugs prescribed by the State Council.

 

  The inspection fee items and charging standards for the drugs listed in the preceding paragraph shall be verified and announced by the financial department of the State Council in conjunction with the competent pricing department of the State Council. The method for collecting inspection fees shall be formulated by the financial department of the State Council in conjunction with the drug regulatory department of the State Council.

 

  Article 42 The drug regulatory department of the State Council shall organize investigations on drugs that have been approved for production or import; for drugs that have ineffective effects, adverse reactions or other reasons that endanger human health, the approval number or the registration certificate for imported drugs shall be revoked. . Drugs that have been revoked the approval number or the import drug registration certificate may not be produced or imported, sold or used; those that have been produced or imported shall be destroyed or disposed of by the local drug supervision and administration department.

 

  Article 43 The State implements a drug reserve system.

 

When major disasters, epidemics and other emergencies occur in China, the departments designated by the State Council may urgently call for pharmaceuticals.

 

  Article 44 The State Council has the power to restrict or prohibit exports of drugs that are insufficiently supplied domestically.

 

  Article 45 Import and export of narcotic drugs and psychotropic drugs within the scope of state regulations must hold the "Import Permit" and "Export Permit" issued by the drug regulatory authority under the State Council..

 

  Article 86 If a drug inspection agency issues a false inspection report, which constitutes a crime, it shall be investigated for criminal responsibility according to law; if it does not constitute a crime, it shall be ordered to make corrections and give a warning, and the unit shall be imposed a fine of not less than 30,000 yuan but not more than 50,000 yuan; Responsible supervisors and other directly responsible personnel shall be given disciplinary actions for downgrading, dismissal, and expulsion, and a fine of not more than 30,000 yuan; if there is illegal income, the illegal income shall be confiscated; if the circumstances are serious, the qualification for inspection shall be revoked. If the inspection result issued by the drug inspection agency is untrue, and the loss is caused, it shall bear the corresponding liability for compensation.

 

  Article 87 The administrative penalties stipulated in Articles 73 to 87 of this Law shall be decided by the drug regulatory authority at or above the county level in accordance with the division of responsibilities prescribed by the drug regulatory authority under the State Council; the drug production license shall be revoked. The "drug business license, "medical institution preparation license", medical institution practice license or the withdrawal of the drug approval certificate shall be determined by the original license and approved department.

 

  Article 88 Anyone who violates the provisions of Articles 55 and 56 of this Law on the administration of drug prices shall be punished in accordance with the provisions of the Price Law of the People's Republic of China.

 

  Article 89 If a pharmaceutical production enterprise, a business enterprise or a medical institution secretly grants, receives or receives rebates or other interests in the purchase and sale of drugs, the pharmaceutical production enterprise, the operating enterprise or its agent shall give the person in charge of the medical institution using the drug. If the drug purchaser, doctor or other relevant personnel use property or other interests, the industrial and commercial administrative department shall impose a fine of not less than 10,000 yuan but not more than 200,000 yuan. If there is illegal income, it shall be confiscated; if the circumstances are serious, the industrial and commercial administration shall be The department revokes the business license of the pharmaceutical production enterprise and the pharmaceutical business enterprise, and informs the drug regulatory authority that the drug regulatory authority revokes its Pharmaceutical Production License and Drug Business License; if it constitutes a crime, it shall be investigated for criminal responsibility according to law.

 

  Article 90 If the pharmaceutical production enterprise, the person in charge of the business enterprise, the procurement personnel and other relevant personnel accept the property or other benefits granted by other production enterprises, operating enterprises or their agents in the purchase and sale of drugs, they shall be punished according to law and the illegal income shall be confiscated. ;Constitute a crime, be held criminally responsible.

 

  If the person in charge of the medical institution, the drug purchaser, or the physician accepts the property or other benefits granted by the pharmaceutical production enterprise, the pharmaceutical business enterprise or its agent, the health administrative department or the unit shall give disciplinary action and confiscate the illegal income; A practicing physician with a serious behavioral situation shall be revoked by the health administrative department for his practice certificate; if a crime is constituted, criminal responsibility shall be investigated according to law.

 

  Article 91 Anyone who violates the provisions on the administration of drug advertisements in this Law shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China, and the drug supervision and administration department that issues the approval number of the advertisement shall revoke the approval number of the advertisement, not within one year. Accept the application for advertisement approval of the variety; if it constitutes a crime, pursue criminal responsibility according to law.

 

  If the drug supervision and administration department fails to perform the review duties on drug advertisements, and the advertisements approved for publication are false or otherwise violate the laws and administrative regulations, the directly responsible persons and other directly responsible personnel shall be given administrative sanctions according to law; Criminal responsibility shall be investigated according to law.

 

  Article 92 If a pharmaceutical production enterprise, a business enterprise or a medical institution violates the provisions of this Law and causes damage to a drug user, it shall be liable for compensation according to law.

 

  Article 93 If a drug regulatory authority violates the provisions of this Law and has one of the following acts, its superior competent authority or supervisory organ shall order it to recover the certificate issued in violation of the law and revoke the drug approval certificate, and the person directly responsible shall Other directly responsible persons shall be given administrative sanctions according to law; if they constitute a crime, criminal responsibility shall be investigated according to law:

 

  (1) For enterprises that do not meet the "Good Manufacturing Practices" and "Good Manufacturing Practices", the enterprises that have obtained the certificates that meet the relevant standards, or the enterprises that have obtained the certificates fail to perform the follow-up inspections in accordance with the regulations, An enterprise that does not meet the certification requirements is not ordered to correct or revoke its certification;

 

  (2) issuing a Pharmaceutical Production License, a Pharmaceutical Business License or a Medical Device Preparation License to a unit that does not meet the statutory conditions;

 

  (3) issuing a certificate of registration for imported drugs for drugs that do not meet the import conditions;

 

  (4) Approving clinical trials, issuing new drug certificates, and issuing drug approval documents without clinical test conditions or production conditions.

 

  Article 94 If the drug regulatory authority or its drug testing agency or its designated professional drug testing institution participates in the drug production and management activities, its superior authority or the supervisory organ shall order it to make corrections, and the illegal income shall be confiscated; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law.

 

  Where the drug supervision and administration department or the drug inspection agency set up by it or the staff of the institution specialized in drug inspection determined by itself participate in the drug production and management activities, administrative sanctions shall be given according to law.

 

  Article 95 If the drug supervision and administration department or its established and determined drug inspection agency illegally collects the inspection fee during drug supervision and inspection, the relevant government department shall order it to be returned, and the directly responsible person in charge and other directly responsible personnel shall be given administrative power according to law. Disciplinary action. The drug inspection agency that violates the law and charges the inspection fee seriously shall revoke its inspection qualification.

 

  Article 96 The drug supervision and administration department shall perform the duties of supervision and inspection according to law, and supervise the enterprises that have obtained the "Pharmaceutical Production License" and "Pharmaceutical Business License" to engage in drug production and business activities in accordance with the provisions of this Law.

 

  If an enterprise that has obtained the "Pharmaceutical Production License" or "Pharmaceutical Business License" produces or sells counterfeit drugs or inferior drugs, it shall be directly responsible for the drug supervision and administration department that has dereliction of duty or misconduct, in addition to legally prosecuting the legal responsibility of the enterprise. The competent personnel and other directly responsible personnel shall be given administrative sanctions according to law; if they constitute a crime, they shall be investigated for criminal responsibility according to law.

 

  Article 97 The drug supervision and administration department shall order the administrative action of the lower-level drug supervision and administration department to violate this Law, and order it to make corrections within a time limit; if it fails to make corrections within the time limit, it shall have the right to change or revoke it.

 

  Article 98 If a drug supervision and management personnel abuses their powers, engages in malpractices for personal gains, or neglects their duties, and constitutes a crime, it shall be investigated for criminal responsibility according to law; if it does not constitute a crime, it shall be given administrative sanctions according to law.

 

  Article 99 The amount of goods stipulated in this Chapter shall be calculated at the price of illegally producing and selling drugs; if there is no price, it shall be calculated according to the market price of similar drugs.

 

 

 

Chapter X Supplementary Provisions

 

  Article 100 The meanings of the following terms in this Law are:

 

  Drugs refer to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiology and stipulate indications or functional indications, usage and dosage, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, and chemical raw materials. Medicines and their preparations, antibiotics, biochemicals, radiopharmaceuticals, serum, vaccines, blood products and diagnostics.

 

  Excipients refer to the excipients and additives used in the manufacture of pharmaceuticals and formulation.

 

  A pharmaceutical production enterprise refers to a franchised enterprise or a concurrent enterprise that produces drugs.

 

  A pharmaceutical business enterprise refers to a franchised enterprise or a concurrent enterprise that operates drugs.

 

  Article 101 The administrative measures for the cultivation, collection and rearing of Chinese herbal medicines shall be formulated separately by the State Council.

 

  Article 102 The State exercises special management over the circulation of preventive biological products. Specific measures shall be formulated by the State Council.

 

  Article 103 The specific measures for the implementation of this Law by the Chinese People's Liberation Army shall be formulated by the State Council and the Central Military Commission in accordance with this Law.

 

  Article 104 This Law shall come into force on December 1, 2001.

 

  Article 46 New discoveries and drugs introduced from abroadThe materials can only be sold after being examined and approved by the drug regulatory department of the State Council.

 

  Article 47 The administrative measures for regional folk customary medicinal materials shall be formulated by the drug regulatory department of the State Council in conjunction with the Chinese medicine administrative department of the State Council.

 

  Article 48 Production (including preparation, the same below) and the sale of counterfeit drugs are prohibited.

 

  In one of the following circumstances, it is a counterfeit drug:

 

  (1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards;

 

  (2) pretending to be a non-pharmaceutical drug or pretending to be a drug with other drugs.

 

  A drug that has one of the following conditions is treated as a counterfeit drug:

 

  (1) The drug regulatory department of the State Council stipulates that it is prohibited from being used;

 

  (2) It must be approved in accordance with this Law and produced or imported without approval, or must be inspected in accordance with this Law and sold without inspection;

 

  (3) Deteriorating;

 

  (4) being polluted;

 

  (5) using the bulk drug that must obtain the approval number in accordance with this Law without obtaining the approval number;

 

  (6) The indicated indications or functional indications are beyond the prescribed scope.

 

  Article 49 It is forbidden to produce or sell inferior drugs. If the content of pharmaceutical ingredients does not meet the national drug standards, it is a bad drug.

 

  A drug that has one of the following conditions is treated as a bad drug:

 

  (1) failing to indicate the validity period or changing the validity period;

 

  (2) failing to indicate or change the production batch number;

 

  (3) exceeding the period of validity;

 

  (4) The packaging materials and containers that are in direct contact with the drug are not approved;

 

  (5) Adding coloring agents, preservatives, spices, flavoring agents and auxiliary materials without authorization;

 

  (6) Others that do not meet the requirements of the drug standard.

 

  Article 50 The name of a drug listed in the national drug standard is the generic name of the drug. Already a generic name for a drug, the name may not be used as a pharmaceutical trademark.

 

  Article 51 Workers who directly contact pharmaceuticals in pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions must conduct annual health checks. Those who suffer from infectious diseases or other diseases that may contaminate drugs shall not engage in direct contact with drugs.

 

 

 

Chapter VI Management of Pharmaceutical Packaging

 

  Article 52 Packaging materials and containers that are in direct contact with drugs must meet the requirements of medicinal requirements and meet the standards for safeguarding human health and safety. The drug regulatory authorities shall also examine and approve the drugs at the time of examination and approval. Pharmaceutical manufacturers must not use unapproved packaging materials and containers that are in direct contact with pharmaceuticals. The packaging materials and containers for unqualified direct contact with drugs shall be ordered to stop using by the drug regulatory authority.

 

  Article 53 Pharmaceutical packaging must be suitable for the quality of pharmaceuticals and convenient for storage, transportation and medical use. Chinese herbal medicines must be packaged. On each package, the name of the product, the place of origin, the date, and the unit to be transferred must be indicated, along with a mark of acceptable quality.

 

  Article 54 Pharmaceutical packaging must be printed or labelled and accompanied by instructions.

 

  The label or instructions must indicate the generic name, composition, specifications, manufacturer, approval number, product batch number, date of manufacture, expiration date, indications or indications, usage, dosage, contraindications, adverse reactions, and precautions.

 

  Labels for narcotic drugs, psychotropic substances, medical toxic drugs, radioactive drugs, topical drugs and over-the-counter drugs must be printed with the prescribed mark.

 

 

 

Chapter VII Drug Price and Advertising Management

 

  Article 55 For drugs that are subject to market-adjusted prices according to law, pharmaceutical production enterprises, operating enterprises and medical institutions shall, in accordance with the principles of fairness, reasonableness, honesty, credit, and quality, set prices to provide medicines with reasonable prices.

 

  Pharmaceutical production enterprises, operating enterprises and medical institutions shall abide by the regulations of the competent pricing department of the State Council on drug price management, formulate and mark the retail price of drugs, and prohibit price fraud and the price fraud that harms the interests of drug users.

 

  Article 56 Pharmaceutical production enterprises, operating enterprises and medical institutions shall provide the government price administration department with information on the actual purchase and sale prices and purchase and sales quantities of their drugs.

 

  Article 57 Medical institutions shall provide patients with a list of prices of drugs used; medical institutions designated by medical insurance shall truthfully announce the prices of their commonly used drugs in accordance with the prescribed methods and strengthen the management of rational drug use. The specific measures shall be prescribed by the health administrative department of the State Council.

 

  Article 58 Production enterprises, business enterprises and medical institutions that prohibit drugs shall secretly give, receive or receive rebates or other benefits in the purchase and sale of drugs.

 

  The manufacturer, the business enterprise or its agent of the banned drug shall, in any name, give the person in charge of the medical institution using the drug, the drug purchaser, the physician and other relevant personnel a property or other interest. It is forbidden for the person in charge of the medical institution, the drug purchaser, the physician, etc. to accept the property or other benefits granted by the manufacturer, business enterprise or agent of the drug in any name.

 

  Article 59 Drug advertisements shall be approved by the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government, and the drug advertisement approval number shall be issued; if the drug advertisement approval number is not obtained, it shall not be released.

 

  Prescription drugs can be introduced in medical and pharmaceutical professional publications jointly designated by the health administrative department of the State Council and the drug regulatory authority under the State Council, but advertisements may not be published in the mass media or otherwise targeted by the public.

 

  Article 60 The content of drug advertisements must be true and legal. The instructions approved by the drug regulatory authority under the State Council shall prevail and shall not contain false content.

 

  Drug advertisements must not contain unscientific assertions or guarantees of efficacy; they should not be used as evidence in the name and image of state organs, medical research institutions, academic institutions or experts, scholars, physicians, or patients.

 

  Non-pharmaceutical advertisements may not have propaganda involving drugs.

 

  Article 61 The drug supervision and administration department of the people's government of a province, autonomous region or municipality directly under the Central Government shall examine the drug advertisements approved by it, and shall notify the advertising supervision and administration authority of the advertisements in violation of this Law and the Advertising Law of the People's Republic of China. The handling supervision proposal shall be handled by the advertising supervision and administration organ according to law.

 

  Article 62 Where the price and advertisement of drugs are not stipulated in this Law, the provisions of the Price Law of the People's Republic of China and the Advertising Law of the People's Republic of China shall apply.

 

 

 

Chapter VIII Drug Supervision

 

  Article 63 The drug supervision and administration department has the right to supervise and inspect the drug development and the production and operation of drugs and the use of drugs by medical institutions in accordance with the provisions of laws and administrative regulations. Relevant units and individuals may not refuse and hide.

 

  When the drug supervision and administration department conducts supervision and inspection, it must present the certification documents, and the technical secrets and business secrets of the inspected persons who are aware of the supervision and inspection shall be kept confidential.

 

  Article 64 The drug supervision and administration department may conduct spot checks on the quality of drugs according to the needs of supervision and inspection. Sampling inspections shall be sampled in accordance with regulations and no fees shall be charged. The required expenses are subject to the provisions of the State Council.

 

  The drug regulatory authority may take administrative enforcement measures for the seizure and seizure of drugs and related materials that may prove to be harmful to human health, and make administrative decisions within seven days; if the drugs need to be inspected, they must be issued from the date of the inspection report. The administrative decision was made within 15 days.

 

  Article 65 The drug regulatory department of the State Council and the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall regularly announce the results of random inspections of drug quality; if the announcement is improper, it must be corrected within the scope of the original announcement.

 

  Article 66 If a party has any objection to the inspection result of the drug inspection agency, it may apply to the drug inspection agency set up or determined by the original drug inspection agency or the superior drug regulatory authority within seven days from the date of receipt of the drug inspection result. The examination may also be directly applied to the drug inspection agency set up or determined by the drug regulatory authority under the State Council for re-inspection. The drug inspection agency that accepts the re-inspection must make a re-inspection conclusion within the time limit prescribed by the drug regulatory authority under the State Council.

 

  Article 67 The drug supervision and administration department shall, in accordance with the provisions, conduct follow-up inspections on the certification of pharmaceutical production enterprises and pharmaceutical enterprises that have passed the certification in accordance with the "Good Manufacturing Practices" and "Good Manufacturing Practices".

 

  Article 68 The local people's government and the drug regulatory authority shall not restrict or exclude drugs produced by non-local pharmaceutical production enterprises in accordance with the provisions of this Law from entering the region by means of drug testing, examination and approval.

 

  Article 69 The drug supervision and administration department and the drug inspection agency set up by it and the established institution specialized in drug inspection shall not participate in the drug production and operation activities, and may not recommend or supervise or supervise drugs in its name.

 

  The drug supervision and administration department and the drug inspection agency set up by it and the staff of the established professional drug inspection agency shall not participate in the drug production and operation activities.

 

  Article 70 The State implements a reporting system for adverse drug reactions. Drug manufacturers, drug companies and medical institutions must constantly check the quality, efficacy and response of the drugs produced, operated and used by their own units. Serious adverse reactions related to drug use may be reported to the drug regulatory authorities and health administrative departments of the local provinces, autonomous regions, and municipalities directly under the Central Government. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health administrative department of the State Council.

 

  For drugs that have confirmed serious adverse reactions, the State Council or the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may adopt emergency control measures to stop production, sale, and use, and shall organize the appraisal within five days. The administrative decision was made in accordance with the law within 15 days from the date of the day.

 

  Article 71 Pharmaceutical testing institutions or personnel of pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions shall accept the business guidance of the drug testing agencies set up by the local drug regulatory authorities.

 

 

 

Chapter IX Legal Liability

 

  Article 72 If a drug production license or a drug license is not obtained from the Pharmaceutical Production License or the Pharmaceutical License, the drug shall be banned according to law, and the illegally produced and sold drugs and illegal proceeds shall be confiscated. And the fines for the production and sale of illegal drugs (including sold and unsold drugs, the same below) are more than two times and five times the value of the goods; if a crime is committed, criminal responsibility shall be investigated according to law.

 

  Article 73 Whoever produces or sells counterfeit drugs shall be confiscated illegally produced and sold drugs and illegal gains, and shall be imposed a fine of not more than two times and five times the value of the drug produced or sold illegally; And ordered to suspend production, suspend business for rectification; if the circumstances are serious, the "drug production license", "drug business license" or "medical institution preparation license" shall be revoked; if a crime is constituted, criminal responsibility shall be investigated according to law.

 

  Article 74 Whoever produces or sells inferior drugs shall confiscate illegally produced and sold drugs and illegal gains, and impose a fine of more than one time and three times the value of illegally produced or sold drugs; if the circumstances are serious, order to suspend production or suspend business. To rectify or revoke the drug approval certificate, revoke the "drug production license", "drug business license" or "medical institution preparation license"; if it constitutes a crime, criminal responsibility shall be investigated according to law.

 

  Article 75 Enterprises or other units engaged in the production and sale of counterfeit medicines and the production or sale of inferior drugs shall not be allowed to engage in the production or operation of pharmaceuticals within 10 years. The raw and auxiliary materials, packaging materials and production equipment specially used by the producers for the production of counterfeit and inferior drugs shall be confiscated.

 

  Article 76 Anyone who knows or should know that it is a counterfeit and inferior drug and provides transportation, storage, warehousing and other convenient conditions shall confiscate all the income from transportation, storage and warehousing, and shall be at least 50% or less of the illegal income. a fine; if it constitutes a crime, it shall be investigated for criminal responsibility according to law.

 

  Article 77 The notice of punishment for counterfeit drugs and inferior drugs must state the quality inspection results of the drug inspection agency; however, Article 48, paragraph 3 (1), (2) and (5) of this Law Except as provided in paragraph (6) and paragraph 39 of Article 49.

 

  Article 78: Pharmaceutical production enterprises, operating enterprises, non-clinical safety evaluation research institutions, and drug clinical trial institutions fail to implement the "Good Manufacturing Practices", "Good Manufacturing Practices", and non-clinical studies of drugs in accordance with regulations. Quality management norms, drug clinical trial quality management norms, give warnings, order to correct within a time limit; if the overdue is not corrected, order to suspend production, suspend business for rectification, and impose a fine of 5,000 yuan or more and 20,000 yuan or less; if the circumstances are serious, the drug is revoked Qualifications for Production License, Drug Business License and Drug Clinical Trial Institutions.

 

  Article 79 If a pharmaceutical production enterprise, business enterprise or medical institution violates the provisions of Article 34 of this Law and purchases drugs from enterprises without the Pharmaceutical Production License or the Pharmaceutical Business License, it shall be ordered to make corrections. , confiscate illegally purchased drugs, and impose a fine of not less than two times and five times the value of the illegally purchased drugs; if there is illegal income, the illegal income shall be confiscated; if the circumstances are serious, the drug production license and the drug business license shall be revoked. Certificate or medical institution license.

 

  Article 80 If a drug that has obtained a drug import registration certificate has not been registered and filed with the drug regulatory authority at the port where the drug is imported in accordance with this Regulation, it shall be given a warning and ordered to make corrections within a time limit; if it is not corrected within the time limit, the registration of the drug shall be revoked. certificate.

 

Article 81 Anyone who forges, alters, trades, leases, lends a permit or a drug approval certificate shall confiscate the illegal income and impose a fine of more than one time and three times the illegal income; if there is no illegal income, the amount shall be 20,000 yuan. If the circumstances are serious, and the seller, the lessor, or the lender's "pharmaceutical production license", "drug business license", "medical institution preparation license" or the drug approval certificate shall be revoked; Constitute a crime, be held criminally responsible.

 

  Article 82: In violation of the provisions of this Law, provide false certificates, documents and documents or other deceptive means to obtain the "Pharmaceutical Production License", "Drug Business License", "Medical Agency Preparation License" or drug approval certificate The drug production license, the drug business license, the medical institution preparation license or the drug approval certificate shall be revoked, and the application shall not be accepted within five years, and a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed. .

 

  Article 83 If a medical institution sells its prepared preparations in the market, it shall be ordered to correct, confiscate the illegally sold preparations, and impose a fine of more than one time and three times the value of the illegally sold preparations; if there is illegal income, the confiscation is illegal. Income.

 

  Article 84 If a pharmaceutical business enterprise violates the provisions of Articles 18 and 19 of this Law, it shall be ordered to make corrections and be given a warning; if the circumstances are serious, the Pharmaceutical Business License shall be revoked.

 

  Article 85 If the drug identification does not comply with the provisions of Article 54 of this Law, it shall be ordered to correct and be given a warning, except for the case that it shall be treated according to the law of counterfeit or inferior drugs. If the circumstances are serious, the approval document for the drug shall be revoked..

 

  Article 86 If a drug inspection agency issues a false inspection report, which constitutes a crime, it shall be investigated for criminal responsibility according to law; if it does not constitute a crime, it shall be ordered to make corrections and give a warning, and the unit shall be imposed a fine of not less than 30,000 yuan but not more than 50,000 yuan; Responsible supervisors and other directly responsible personnel shall be given disciplinary actions for downgrading, dismissal, and expulsion, and a fine of not more than 30,000 yuan; if there is illegal income, the illegal income shall be confiscated; if the circumstances are serious, the qualification for inspection shall be revoked. If the inspection result issued by the drug inspection agency is untrue, and the loss is caused, it shall bear the corresponding liability for compensation.

 

  Article 87 The administrative penalties stipulated in Articles 73 to 87 of this Law shall be decided by the drug regulatory authority at or above the county level in accordance with the division of responsibilities prescribed by the drug regulatory authority under the State Council; the drug production license shall be revoked. The "drug business license, "medical institution preparation license", medical institution practice license or the withdrawal of the drug approval certificate shall be determined by the original license and approved department.

 

  Article 88 Anyone who violates the provisions of Articles 55 and 56 of this Law on the administration of drug prices shall be punished in accordance with the provisions of the Price Law of the People's Republic of China.

 

  Article 89 If a pharmaceutical production enterprise, a business enterprise or a medical institution secretly grants, receives or receives rebates or other interests in the purchase and sale of drugs, the pharmaceutical production enterprise, the operating enterprise or its agent shall give the person in charge of the medical institution using the drug. If the drug purchaser, doctor or other relevant personnel use property or other interests, the industrial and commercial administrative department shall impose a fine of not less than 10,000 yuan but not more than 200,000 yuan. If there is illegal income, it shall be confiscated; if the circumstances are serious, the industrial and commercial administration shall be The department revokes the business license of the pharmaceutical production enterprise and the pharmaceutical business enterprise, and informs the drug regulatory authority that the drug regulatory authority revokes its Pharmaceutical Production License and Drug Business License; if it constitutes a crime, it shall be investigated for criminal responsibility according to law.

 

  Article 90 If the pharmaceutical production enterprise, the person in charge of the business enterprise, the procurement personnel and other relevant personnel accept the property or other benefits granted by other production enterprises, operating enterprises or their agents in the purchase and sale of drugs, they shall be punished according to law and the illegal income shall be confiscated. ;Constitute a crime, be held criminally responsible.

 

  If the person in charge of the medical institution, the drug purchaser, or the physician accepts the property or other benefits granted by the pharmaceutical production enterprise, the pharmaceutical business enterprise or its agent, the health administrative department or the unit shall give disciplinary action and confiscate the illegal income; A practicing physician with a serious behavioral situation shall be revoked by the health administrative department for his practice certificate; if a crime is constituted, criminal responsibility shall be investigated according to law.

 

  Article 91 Anyone who violates the provisions on the administration of drug advertisements in this Law shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China, and the drug supervision and administration department that issues the approval number of the advertisement shall revoke the approval number of the advertisement, not within one year. Accept the application for advertisement approval of the variety; if it constitutes a crime, pursue criminal responsibility according to law.

 

  If the drug supervision and administration department fails to perform the review duties on drug advertisements, and the advertisements approved for publication are false or otherwise violate the laws and administrative regulations, the directly responsible persons and other directly responsible personnel shall be given administrative sanctions according to law; Criminal responsibility shall be investigated according to law.

 

  Article 92 If a pharmaceutical production enterprise, a business enterprise or a medical institution violates the provisions of this Law and causes damage to a drug user, it shall be liable for compensation according to law.

 

  Article 93 If a drug regulatory authority violates the provisions of this Law and has one of the following acts, its superior competent authority or supervisory organ shall order it to recover the certificate issued in violation of the law and revoke the drug approval certificate, and the person directly responsible shall Other directly responsible persons shall be given administrative sanctions according to law; if they constitute a crime, criminal responsibility shall be investigated according to law:

 

  (1) For enterprises that do not meet the "Good Manufacturing Practices" and "Good Manufacturing Practices", the enterprises that have obtained the certificates that meet the relevant standards, or the enterprises that have obtained the certificates fail to perform the follow-up inspections in accordance with the regulations, An enterprise that does not meet the certification requirements is not ordered to correct or revoke its certification;

 

  (2) issuing a Pharmaceutical Production License, a Pharmaceutical Business License or a Medical Device Preparation License to a unit that does not meet the statutory conditions;

 

  (3) issuing a certificate of registration for imported drugs for drugs that do not meet the import conditions;

 

  (4) Approving clinical trials, issuing new drug certificates, and issuing drug approval documents without clinical test conditions or production conditions.

 

  Article 94 If the drug regulatory authority or its drug testing agency or its designated professional drug testing institution participates in the drug production and management activities, its superior authority or the supervisory organ shall order it to make corrections, and the illegal income shall be confiscated; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law.

 

  Where the drug supervision and administration department or the drug inspection agency set up by it or the staff of the institution specialized in drug inspection determined by itself participate in the drug production and management activities, administrative sanctions shall be given according to law.

 

  Article 95 If the drug supervision and administration department or its established and determined drug inspection agency illegally collects the inspection fee during drug supervision and inspection, the relevant government department shall order it to be returned, and the directly responsible person in charge and other directly responsible personnel shall be given administrative power according to law. Disciplinary action. The drug inspection agency that violates the law and charges the inspection fee seriously shall revoke its inspection qualification.

 

  Article 96 The drug supervision and administration department shall perform the duties of supervision and inspection according to law, and supervise the enterprises that have obtained the "Pharmaceutical Production License" and "Pharmaceutical Business License" to engage in drug production and business activities in accordance with the provisions of this Law.

 

  If an enterprise that has obtained the "Pharmaceutical Production License" or "Pharmaceutical Business License" produces or sells counterfeit drugs or inferior drugs, it shall be directly responsible for the drug supervision and administration department that has dereliction of duty or misconduct, in addition to legally prosecuting the legal responsibility of the enterprise. The competent personnel and other directly responsible personnel shall be given administrative sanctions according to law; if they constitute a crime, they shall be investigated for criminal responsibility according to law.

 

  Article 97 The drug supervision and administration department shall order the administrative action of the lower-level drug supervision and administration department to violate this Law, and order it to make corrections within a time limit; if it fails to make corrections within the time limit, it shall have the right to change or revoke it.

 

  Article 98 If a drug supervision and management personnel abuses their powers, engages in malpractices for personal gains, or neglects their duties, and constitutes a crime, it shall be investigated for criminal responsibility according to law; if it does not constitute a crime, it shall be given administrative sanctions according to law.

 

  Article 99 The amount of goods stipulated in this Chapter shall be calculated at the price of illegally producing and selling drugs; if there is no price, it shall be calculated according to the market price of similar drugs.

 

 

 

Chapter X Supplementary Provisions

 

  Article 100 The meanings of the following terms in this Law are:

 

  Drugs refer to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiology and stipulate indications or functional indications, usage and dosage, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, and chemical raw materials. Medicines and their preparations, antibiotics, biochemicals, radiopharmaceuticals, serum, vaccines, blood products and diagnostics.

 

  Excipients refer to the excipients and additives used in the manufacture of pharmaceuticals and formulation.

 

  A pharmaceutical production enterprise refers to a franchised enterprise or a concurrent enterprise that produces drugs.

 

  A pharmaceutical business enterprise refers to a franchised enterprise or a concurrent enterprise that operates drugs.

 

  Article 101 The administrative measures for the cultivation, collection and rearing of Chinese herbal medicines shall be formulated separately by the State Council.

 

  Article 102 The State exercises special management over the circulation of preventive biological products. Specific measures shall be formulated by the State Council.

 

  Article 103 The specific measures for the implementation of this Law by the Chinese People's Liberation Army shall be formulated by the State Council and the Central Military Commission in accordance with this Law.

 

  Article 104 This Law shall come into force on December 1, 2001.