The Decree of the President of the People's Republic of China (No.5)

The Drug Administration Law of the People's Republic of China was revised and adopted on February 28, 2001 at the Twentieth Session of the Standing Committee of the Ninth National People's Congress, and the revised version is hereby promulgated. This law shall enter into force as of December 1, 2001.

JIANG ZEMIN
President of the People's Republic of China
February 28, 2001
(Adopted at the Seventh Session of the Standing Committee of the Fifth National People's Congress on September 20, 1984.  Amended at the Twentieth Session of the Standing Committee of the Ninth National People's Congress on February 28, 2001.)

CONTENTS

CHAPTER  I  GENERAL PROVISIONS
CHAPTER  II ADMINISTRATION OF DRUG MANUFACTURING ENTERPRISES
CHAPTER  III  ADMINISTRATION OF DRUG DISTRIBUTING ENTERPRISES
CHAPTER  IX  ADMINISTRATION OF DRUGS AT MEDICAL INSTITUTIONS
CHAPTER  X  ADMINISTRATION OF DRUGS
CHAPTER  XI  ADMINISTRATION OF PACKAGING OF DRUGS
CHAPTER  XII  ADMINISTRATION OF PRICING AND ADVERTING OF DRUGS
CHAPTER  XIII SUPERVISION OVER DRUGS
CHAPTER  IX LEGAL RESPONSIBILITIES
CHAPTER  X SUPPLEMENTARY PROVISIONS 

CHAPTER I
GENERAL ROVISIONS

Article 1  This law is formulated with a view to enhancing the supervision and control of drugs, ensuring their quality, guaranteeing safety in medication and safeguarding the health of the people and their legal rights in medication.

Article 2  The organizations or individuals engaged in drug research, production, distribution, use and administration within the boundary of the People's Republic of China should comply with this law.

Article 3  The State shall develop both modern and traditional drugs, giving full play to their roles in the prevention and treatment of diseases as well as in the provision of health care.
      The State shall protect the resources of wild herbs and encourage the domestic cultivation of traditional Chinese medicinal herbs.

Article 4  The State shall encourage the research and innovation of new drugs and protect the legal rights of citizens, juridical persons and organizations engaged in the research and development of new drugs.

Article 5  The national drug regulatory authority shall take charge of the supervision and administration of drugs nationwide. The appropriate authorities under the State Council involve themselves in drug supervision and administration within their own terms of reference.
     The local drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the supervision and administration of drugs within their own jurisdictions. The relevant authorities of provinces, autonomous regions and municipalities directly under the central government involve themselves in drug supervision and administration within their own terms of reference.
     The national drug regulatory authority shall collaborate with the state economic management authority to implement development plan and policy of the nation's pharmaceutical industry.

Article 6  The drug control institutes established or authorized by the drug regulatory authorities shall take charge of the examination of drugs to exercise drug approval and quality control pursuant to the law.

CHAPTER II
ADMINISTRATION OF DRUG MANUFACTURING ENTERPRISES

Article 7  The establishment of a drug manufacturing enterprise must be sanctioned and require a Drug Manufacturing License to be issued by the local drug regulatory authority of the province, autonomous region or municipality directly under the central government. The place of issuance should be the place where the enterprise is located, and where it is registered at the administrative authority for industry and commerce. Without such a license, drug manufacturing is prohibited.
       The Drug Manufacturing License shall indicate a period of validity and manufacturing scale, upon expiration of which a new license may be issued after examination of its renewal application.
       The approval of establishing a drug manufacturing enterprise by the drug regulatory authorities shall conform to the provisions of Article 8 of this Law, and to the development plan and policy of the nation's pharmaceutical industry so as to prevent project duplications. 

Article 8  To establish a drug manufacturing enterprise, the following requirements must be met:
(1) It shall be staffed with necessary legally certificated pharmaceutical technicians, engineering technicians as well as appropriate skilled workers;
(2) It shall have factory premises, facilities and a sanitary environment suitable for drug production;
(3) It shall have a quality management and quality control system with competent personnel and necessary instrument and equipment for inspecting the quality of the drugs produced;
(4) It shall have rules and regulations to ensure the quality of the drugs produced.

Article 9  The production of a drug manufacturing enterprise shall be carried out in accordance with the Good Manufacturing Practice (GMP) formulated by the national drug regulatory authority based on this Law. The drug regulatory authorities shall verify drug manufacturing enterprises according to GMP, and certificates shall be granted to qualified enterprises.
       The national drug regulatory authority shall prescribe the procedures for implementing GMP.

Article 10  Drug production, except for the processing of pieces of traditional Chinese medicinal herbs, shall be carried out in accordance with the national drug standard and production process approved by the national drug regulatory authorities, making complete and accurate production records available. Any change in the production process shall be reported by the drug manufacturing enterprise for approval by the drug regulatory authorities which endorsed the production.
      The preparation of processed of pieces of traditional Chinese medicinal herbs shall follow the national drug standard, or if such standard is not available, the processing standard formulated by the local drug regulatory authorities of provinces, autonomous regions or municipalities directly under the central government. The processing standard formulated by the local drug regulatory authorities of the provinces, autonomous regions or municipalities directly under the central government shall be filed at the sate drug regulatory authority.

Article 11  Raw materials and adjuvant used for the production of drugs must conform to the requirements for medical use.

Article 12  The drug manufacturing enterprises must carry out quality control over their products; substandard drugs and processed pieces of traditional Chinese medicinal herbs that fail to meet the processing standard formulated by the local drug regulatory authorities of the provinces, autonomous regions or municipalities directly under the central government shall not be allowed to be dispatched from the factory.

Article 13  A drug manufacturing enterprise may accept toll manufacturing with the approval of the national drug regulatory authority or its designated local drug regulatory authorities of the provinces, autonomous regions or municipalities directly under the central government.  

CHAPTER III
ADMINISTRATION OF DRUG DISTRIBUTING ENTERPRISES

Article 14  The establishment of drug wholesale enterprises shall be sanctioned, and a Drug Distributing License is required which is to be issued by the local drug regulatory authorities of the provinces, autonomous regions or municipalities directly under the central government. The establishment of drug retail enterprises shall be sanctioned, and a Drug Distributing License is required which is to be issued by the local drug regulatory authorities above the county level. The said enterprises shall register at the administrative authority for industry and commerce on the strength of this license, without which, drug distribution is prohibited.
       A period of validity and distributing scale shall be indicated on the Drug Distributing License, upon expiration of which a new license may be issued after examination of its renewal application.
       The approval of establishing drug distributing enterprises by the drug regulatory authorities shall conform to the provisions of Article 15 of this law, and the principle of reasonable distribution of sales outlets and convenient access for people to buy drugs.

Article 15  To establish a drug distributing enterprise, the following requirements must be met:
(1) It shall be staffed with legally certificated pharmaceutical technicians;
(2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for distributing particular kinds of drugs;
(3) It shall have a quality management system or staff competent for distributing particular kinds of drugs;
(4) It shall have rules and regulations to ensure the quality of the drugs distributed.

Article 16  The drug distributing enterprise shall run business complying with the Good Supply Practice (GSP) formulated by the national drug regulatory authority based on this Law. The drug regulatory authority shall verify the drug distributing enterprise complying with GSP, and issue certificates for the qualified enterprises.
       The national drug regulatory authority shall prescribe the procedures for implementing GSP.

Article 17  Rules for inspection of drug purchasing shall be formulated and implemented by drug distributing enterprises. The examination of the quality certificates and appropriate labels must be carried out. Drugs that do not meet the required standards must not be purchased.

Article 18  Authentic and complete distributing records shall be reserved by drug distributing enterprises for purchasing and selling drugs. The records shall indicate the generic name, dosage, strength, lot number, shelf life, manufacturer, purchasing /selling company, purchasing /selling quantity, purchasing /selling price, purchasing /selling date and other items required by the national drug regulatory authority.

Article 19  It is imperative in the distribution of drugs to be accurate and free of errors, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Drugs listed in prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary, unless corrections have been made by the prescriber or re-signed by him.
Traditional Chinese medicinal herbs distributed by the drug distributing enterprise must have their origins indicated.

Article 20  Rules and regulations for storage of drugs shall be formulated and implemented by drug distributing enterprises, which must adopt necessary measures to facilitate cold storage and protection against moisture, insects and rodents, in order to guarantee the quality of drugs.
       An inspection system shall be carried out for drugs entering or leaving warehouses.

Article 21  The sale of traditional Chinese medicinal herbs on the market of town or country fairs is permitted with certain exceptions regulated by the State Council.
       The sale of drugs other than traditional Chinese medicinal herbs on the market of town or country fairs is prohibited, but the drug distributing enterprises holding a Drug Distributing Certificate may set up stalls on the market of town or country fairs, and sell drugs other than traditional Chinese medicinal herbs within the regulated distributing scale. Detailed measures shall be stipulate by the State Council.

CHAPTER IV
ADMINISTRATION OF DRUGS AT MEDICAL INSTITUTIONS

Article 22  Medical institutions must be staffed with legally certificated pharmaceutical technicians. Non-pharmaceutical technicians may not engage directly in drug-related technical work.

Article 23  To make medicinal preparations, a medical institution shall be examined by the health administrative authorities of provinces, autonomous regions or municipalities directly under the central government, in which such institutions are located. And a Drug Dispensing Permit will be issued on approval by the local drug regulatory authorities of provinces, autonomous regions or municipalities directly under the central government. Drug dispensing is prohibited without a Drug Dispensing Permit.
       The Drug Dispensing Permit shall indicate a period of validity, upon expiration of which a new permit may be issued after examination of its renewal application.

Article 24  Medical institutions making medicinal preparations must be equipped with facilities, management systems, inspection instruments and sanitary conditions capable of ensuring the quality of the preparations.

Article 25  The medicinal preparations dispensed in the medical institutions shall be the kinds that are out of supply in the market but needed by the medical institutions where they were dispensed, and shall be approved by the local drug regulatory authorities of provinces, autonomous regions or municipalities directly under the central government. The medicinal preparations dispensed in the medical institutions shall be examined to ensure compliance to appropriate regulations; qualified medicinal preparations shall be prescribed by a physician and used in medical institutions where they were dispensed. In special cases, the medicinal preparations dispensed in one medical institution may be used by other designated medical institutions with the approval of the national drug regulatory authority or authorities of provinces, autonomous regions and municipalities directly under the central government.
     Drug preparations dispensed in medical institutions shall not be distributed on the market.

Article 26  Medical institutions shall set up a system of quality inspection. When purchasing drugs, the drugs must be inspected for the qualification certificate and other indications; substandard drugs are prohibited to be purchased and used.

Article 27  Medicinal preparations dispensed in medical institutions must be checked by the dispensary. The drugs listed in the prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary, unless corrections have been made by the prescriber or re-signed by him.

Article 28  Rules for storage of drugs shall be formulated and implemented by medical institutions, which must adopt necessary measures to facilitate cold storage and protect against freezing, moisture,  insects and rodents so as to maintain the quality of drugs.

CHAPTER V
ADMINISTRATION OF DRUGS

Article 29  For the research and development of new drugs, it is necessary to submit authentic reports on the methods of production, quality standards, pharmacological and toxicological testing results, and other appropriate materials and samples, in accordance with the regulations stipulated by the national drug regulatory authority. Clinical trials can be carried out only with the approval by the national drug regulatory authority. The national drug regulatory authority and state health administrative authority shall jointly formulate the measures for qualification certification of the drug clinical trial institutions.
     The national drug regulatory authority shall give approval and issue the New Drug Certificate for the new drugs that have gone through clinical trials and passed the evaluation.

Article 30  The drug laboratory safety evaluation and research institutions and the drug clinical trials institutions shall implement Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) respectively.
    GLP and GCP shall be formulated by the authorities authorized by the State Council.

Article 31  With the exception of traditional Chinese medicinal herbs and its processed pieces which are not subject to approval numbering administration, a new drug or drug standardized by the state can be put into production only after the national drug regulatory authority has approved it and granted an approval number. The catalogue of the traditional Chinese medicinal herbs and their processed pieces subject to approval numbering administration shall be formulated collaboratively by the national drug regulatory authority and the national regulatory authority of traditional Chinese medicines.
     The drug manufacturing enterprises cannot produce any drugs unless it has been granted the approval number.

Article 32  Drugs must meet the national drug standards. The processed pieces of traditional Chinese medicinal herbs are subject to the provisions of Item 2 of Article 10 of this Law.
     The Pharmacopoeia of the People's Republic of China and the drug standards promulgated by the national drug regulatory authority shall be the national drug standards. 
     The national drug regulatory authority shall be responsible for organizing the Pharmacopoeia Commission, and for the formulation and revision of national drug standards.
The drug control institutes of the national drug regulatory authority are responsible for standardizing the national standard and reference samples. 

Article 33  The national drug regulatory authority shall organize experts in the field of pharmacology and medical science and other technical experts to carry out examination and evaluation of new drugs, and to re-evaluate the drugs already put into production.

Article 34  With the exception of the purchase of traditional Chinese medicinal herbs which are not subject to the approval numbering administration, drug manufacturing enterprises, drug distributing enterprises and medical institutions shall purchase drugs from qualified drug producers and distributors.

Article 35  The state exercises control of narcotics, psychotropics, toxics for medical use and radiopharmaceuticals. Provisions for the control of these drugs shall be formulated by the State Council.

Article 36  The state gives protection to traditional Chinese medicines. The detailed measures shall be formulated by the State Council.

Article 37  The state exercises classified administration of the prescribed and non-prescribed drugs. The detailed measures shall be formulated by the State Council.

Article 38  It is prohibited to import drugs with uncertain efficacy, or drugs that cause adverse reactions or have other harmful effects on human's health.

Article 39  Drugs shall not be allowed to be imported before they have been examined and evaluated by the national drug regulatory authority, and have been confirmed to be up to the quality standard, safe and effective for use and granted an Import Drug License.
Drugs to be imported for urgent needs by medical institutions for clinical treatment or for personal use in small quantities, shall go through the importation procedures in accordance with the appropriate provisions of the state.

Article 40  Drugs shall be imported via the designated ports, and each case shall be reported by the importer to the local drug regulatory authority for registration and documentation. The customs house releases the drugs on the strength of the Customs Clearance Notice of Imported Drugs; without the notice, the customs house shall not release the drugs.
      Upon the notification of the local drug regulatory authority in which the port is located, the drug control institute shall conduct a sampling examination of the import drugs based on the provisions formulated by the national drug regulatory authority, and charge an examination fee according to the provisions of Item 2 of Article 41of this Law.
The ports, via which the drugs are imported, shall be designated by the national drug regulatory authority in conjunction with the Customs General Administration, and approved by the State Council.

Article 41  The national drug regulatory authority shall designate a drug control institute for  pre-marketing or importing examination of the following drugs; substandard drugs shall not be marketed and imported.
Item 1  biological products specified by the national drug regulatory authority;
Item 2  drugs initially distributed in China;
Item 3  other drugs specified by the State Council.
The items and rates of drug examination fees for the above-mentioned drugs are to be ratified and announced by the state finance authority in conjunction with the state pricing authority. The provisions for collecting drug examination fees shall be formulated by the state finance authority in conjunction with the national drug regulatory authority.

Article 42  The national drug regulatory authority shall organize investigations into the cases where drugs have been approved for production or importation. The Production Approval Number or Import Drug License shall be revoked for those drugs with uncertain efficacy, or those cause adverse reactions or have other harmful effects on human's health.
     The drugs, whose Production Approval Number or Import Drug License have been revoked, shall not be produced, imported, distributed or used; for those having been produced or imported, the drugs shall be destroyed or disposed of under the supervision of local drug regulatory authority.

Article 43  The state maintains a drug reserves system.
In the case of serious disasters, epidemic situations, or other emergencies, the authorities designated by the State Council may urgently dispatch drugs from drug manufacturing enterprises.

Article 44  The State Council is authorized to restrict or prohibit the exportation of the drugs in short supply domestically.

Article 45  Importers and exporters of narcotics and psychotropics on the national list of controlled drugs must hold an Import License and Export License granted by the national drug regulatory authority.

Article 46  Newly discovered herbs and herbs introduced from abroad shall not be distributed unless they have passed the examination and approval by the national drug regulatory authority.

Article 47  The provisions applicable to the regional habitually used folk herbs shall be formulated by the national drug regulatory authority in conjunction with the national regualtory authority of traditional Chinese medicines.

Article 48  The production (including making up) and distribution of counterfeit drugs are prohibited. Any of the following categories is considered a counterfeit drug:
* its components are different from those prescribed by the national drug standards;
* a non-medical substance is passed off as a drug, or one drug is passed off as another;
A drug shall be considered a counterfeit drug in any of the following cases:
* the use of the drug has been prohibited by the national drug regulatory authority;
* the production and import of the drug is carried out without approval according to this Law, or the distribution of the drug is carried out without examination according to this Law;
* the drug has deteriorated;
* the drug has been contaminated;
* the drug is produced with raw materials which must be granted an approval number according to this Law but has not been granted one;
* the efficacy or actions indicated outdo those approved by the appropriate authority.

Article 49  The production and distribution of substandard drugs are prohibited.
If the components of a drug do not conform in quantity to that required by the national standards, it is regarded as a substandard drug.
A drug shall be treated as a substandard drug in any of the following cases if :
* the expiry date is unmarked or modified;
* the lot number of production is unmarked or modified;
* the drug has passed its expiry date;
* the packaging materials and containers in direct contact with the drugs are not approved;
* the colorant, preserver, flavor, taste corrective and adjuvant are added presumptuously;
* there are other actions against the provisions of the national drug standards.

Article 50  The drug names included in the national drug standards shall be the generic name of the drugs. The names, which have been used as the generic names of drugs, shall not be used as the trademarks of drugs.

Article 51  Personnel of drug manufacturing and distributing enterprises and medical institutions who have direct contact with drugs must undergo an annual medical examination. Persons suffering from contracted contagious diseases or any other diseases that may contaminate drugs shall not be allowed to engage in any work in which persons have direct contact with drugs.

CHAPTER VI
ADMINISTRATION OF DRUG PACKAGING

Article 52  Drug packaging materials and containers in direct contact with drugs shall meet the requirements for medical use and the standard ensuring human safety, and shall be examined and evaluated together with the drug itself by the drug regulatory authority.
       The drug manufacturing enterprises are prohibited to use unapproved immediate packaging materials and containers.
       Substandard drug packaging materials and containers in direct contact with drugs should be withdrawn by the drug regulatory authority.

Article 53  Drug packaging shall meet the specific quality requirements of the drugs and facilitate their storage, transportation and medical use.
       Traditional Chinese medicinal herbs must be packaged before transportation. There must appear on the package the name of the drug, place of production, date, name of the consigner, and an indication that the quality of the drug is up to standard.

Article 54  The packages of drugs must be in accordance with provisions, be printed or stacked with a label and include package inserts.   
       The label or package insert must indicate the generic name, components, strength, producer, approval number, lot number of the product, producing date, shelf life, indications or actions, usage and dosage, contradictions, adverse reactions and precautions.
       Special indications must be printed as required on the labels of narcotics, psychotropic drugs, toxic drugs for medical use, radioactive drugs, OTC drugs and drugs for external use.

CHAPTER VII
ADMINISTRATION OF PRICING AND ADVERTISING OF DRUGS

Article 55  For drugs whose prices are established or supervised by the government according to law, the price control authorities shall establish and adjust prices in accordance with the Price Law of the People's Republic of China, taking into account the average cost, supply and demand on the market and the affordability of the general public, ensuring good value for money, barring exuberantly high prices so as to protect the lawful rights of drug consumers.
      Drug manufacturing enterprises, drug distributing enterprises and medical institutions must accept prices established and supervised by the government and may not raise drug prices in any way without consent.
      Drug manufacturing enterprises shall report the cost of production and distribution to the price control authority, and may not refuse to report, or report falsely or fraudulently.

Article 56  For drugs whose prices are adjusted by the market, drug manufacturing enterprises, drug distributing enterprises and medical institutions shall establish prices according to the principle of impartiality, reasonableness, honesty and the match between price and quality, so as to supply drugs at reasonable prices to drug consumers.
      Drug manufacturing enterprises, drug distributing enterprises and medical institutions shall comply with the provisions of drug prices, establish and mark retailing prices of drugs. Profiteering and actions infringing the rights of drug consumers are prohibited.

Article 57  Drug manufacturing enterprises, drug distributing enterprises and medical institutions shall report to the price control authorities about actual purchasing/selling prices and quantity.

Article 58  Medical institutions shall offer price lists to drug consumers of the drugs they use; the designated medical institutions for medical insurance shall announce prices of drugs they commonly use, and strengthen rational use of drugs. The detailed measures shall be promulgated by the state health administrative authority.

Article 59  Giving and accepting rebates or other benefits out of the account by drug manufacturing enterprises, drug distributing enterprises and medical institutions are prohibited.
      Drug manufacturing enterprises, drug distributing enterprises and their agents may not give presents or other benefits to the persons in charge, drug buyers and physicians of medical institutions who use their drugs. The persons in charge, drug buyers and physicians of medical institutions are forbidden to accept presents or other benefits given by drug manufacturing enterprises, drug distributing enterprises and their agents.

Article 60  Advertisements of drugs must be examined, approved and granted approval numbers by the local drug regulatory authorities of provinces, autonomous regions or municipalities directly under the central government. Without the approval number, advertisements of any drugs may not be disseminated.
Prescription drugs may be advertised on professional medical and pharmaceutical journals jointly designated by the state health administrative authority and national drug regulatory authority. Disseminating advertisements on public media or through other forms of publicity to the general public is prohibited.

Article 61  Advertisements of drugs must be authentic and legitimate, without illusive directions, and based on the package insert approved by the national drug regulatory authority.
Advertisements of drugs may not include unscientific assertion and guarantee that promote efficacy; advertising in the name and visual images of the state government, medical and pharmaceutical academic institutions, experts, scholars, physicians and patients shall not be permitted.
Non-drug advertising may not involve itself in drug publicity.

Article 62  Local drug regulatory authorities of provinces, autonomous regions or municipalities directly under the central government shall censor the advertisements they approved, report to the advertising supervision authority and suggest the settlement for those who disobey the Advertising Law of the People's Republic of China, the advertising supervision authority shall dispose the illegal advertisements according to law.    

Article 63  All matters related to pricing and advertising of drugs which are not stipulated in this Law shall be governed by the provisions of the Price Law of the People's Republic of China and the Advertising Law of the People's Republic of China. 

CHAPTER VIII
SUPERVISION OVER DRUGS

Article 64  Drug regulatory authorities are authorized to exercise, in accordance with the law and administrative regulations, supervision and inspection over the research and development, manufacture, distribution and use in medical institutions of drugs they examined and evaluated. The enterprises, institutions and individuals may not refuse such requests or withhold appropriate data.
     When inspecting, the drug regulatory authority must show warrant documents and keep technical and business secrets for the inspected.

Article 65  Drug regulatory authorities shall conduct sampling examinations as regards the quality of drugs if necessary. The sampling examination shall be carried out according to relative regulations free of charge, the sampling examination expenditure shall be included in expenses according to the provisions of the State Council.
     Drug regulatory authorities may take compulsive administrative steps like sealing up and detaining drugs, which are proved to be harmful for human health. Decisions of administrative penalty should be made within 7days; for the drugs needing examination, decisions of administrative penalty shall be made in 15days from the issuing of examination report.

Article 66  The national drug regulatory authority, and the local drug regulatory authorities of provinces, autonomous regions, or municipalities directly under the central government shall timely announce the results of sampling examination. Improper announcement shall be corrected within the sphere of the original announcement.

Article 67  If the party concerned dose not accept the results of the sampling examination, they can apply for re-examination to the original drug control institute or to another of higher rank, or the drug control institute established or authorized by the higher drug regulatory authority within 7days from receiving the examination report, or directly to the drug control institute established or authorized by the national drug regulatory authority. The drug control institutes, which accept the application, must issue a re-examination report in time prescribed by the national drug regulatory authority.

Article 68  Drug regulatory authorities shall carry out follow-up examinations for the qualified drug manufacturing enterprises and drug distributing enterprises according to GMP and GSP.

Article 69  Local governments and drug regulatory authorities may not restrict or exclude drugs produced by drug manufacturing enterprises of other places complying to this Law to enter the local market, by means of subjecting outside products to examination and approval.

Article 70  Drug regulatory authorities, drug control institutes established by them, and institutions authorized by the drug regulatory authorities to professionally engage in drug examination, may not recommend or supervise the manufacture and distribution of drugs in their names.
      Personnel of drug regulatory authorities, drug control institutes established by them, and institutions authorized by the drug regulatory authorities to professionally engage in the examination of drugs may not engage in the production and distribution of drugs.

Article 71  The state sets up a reporting system on adverse reactions. Drug manufacturing enterprises, drug distributing enterprises and medical institutions must regularly review the quality, efficacy and reaction of the drugs they produced, distributed and used. Serious adverse reactions related to the use of drugs, once they are discovered, must be reported to drug regulatory authorities and health administrative authorities of provinces, autonomous regions, or municipalities directly under the central government. The detailed measures in this regard shall be jointly stipulated by the national drug regulatory authority and the state health administrative authority.
      The national drug regulatory authority or drug regulatory authorities of provinces, autonomous regions, or municipalities directly under the central government may take emergent measures to stop the production, distribution and use of drugs which are proved to be liable for serious adverse reactions, and appraisal should be carried out within 5 days, and an administrative disposal be taken in 15 days from the announcement of the result of the appraisal.

Article 72  Drug control institutes and their staff of drug manufacturing enterprises, drug distributing enterprises and medical institutions shall accept the professional guidance from the drug control institutes established by the local drug regulatory authority. 

CHAPTER IX
LEGAL RESPONSIBILITIES

Article 73  Any one engaged in the production or distribution of drugs without obtaining a Drug Manufacturing License, Drug Distributing License or Drug Dispensing Permit shall be deprived of the right of production or distribution of drugs according to law. The produced or distributed drugs (including drugs already sold, and not sold also applicable below) and the illegal gains shall be confiscated, and a floor fine two times and ceiling fine five times, respectively, the value of the drug shall be imposed, and for cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.

Article 74  Those who produce or distribute counterfeit drugs shall have their counterfeit drugs being produced or distributed together with their illegal gains confiscated, and a floor fine two times and ceiling fine five times, respectively, the value of the drug shall be imposed. The drug approval documents shall be withdrawn, and an order shall be made to suspend production and business operations pending rectification.  The Drug Manufacturing License, Drug Distributing License or Drug Dispensing Permit shall be revoked for serious cases; and for cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.

Article 75  Those who produce or distribute substandard drugs shall have their substandard drugs being produced or distributed together with illegal gains confiscated, and a floor fine one time and ceiling fine three times, respectively, the price of the drug shall be imposed; and for serious cases, they shall be ordered to suspend production and business operations pending rectification, their drug approval documents shall be withdrawn, or their Drug Manufacturing License, Drug Distributing License or Drug Dispensing Permit shall be revoked. For serious cases constituting a crime, they shall be prosecuted for criminal offence according to law.

Article 76  In serious cases of enterprises or other organizations going for producing or distributing counterfeit or substandard drugs, the persons directly in charge of and those directly involved in such activities shall be prohibited to be involved in drug production and distribution for 10 years.
      The raw materials, adjuvant, packaging materials and producing facilities used in producing counterfeit or inferior drugs shall be confiscated.

Article 77  Those who provide transportation, safe-keeping and storage facilities for the producer or distributor of counterfeit or substandard drugs and who know or ought to know that they are counterfeit or substandard drugs, shall have all their gains from transportation, safe-keeping and storage confiscated, and a floor fine half times and ceiling fine three times, respectively, the illegal gains shall be imposed; for serious cases constituting a crime, they shall be prosecuted for criminal offence according to law.

Article 78  The penalty notice for counterfeit or substandard drugs must indicate the examination result given by the drug control institutes; except for the conditions regulated by provisions of Term 1, 2, 5, and 6 of Item 3 of Article 48 and Item 3 of Article 49 of this Law.

Article 79  Drug manufacturing and distributing enterprises, drug laboratory safety evaluation and research institutions and drug clinical trials institutions, which do not implement GMP, GSP, GLP and GCP according to the regulations, shall be served a warning and ordered to put things right within a given time limit. Those who do not comply with the penalty within the time limit shall be ordered to suspend production or business operations pending rectification, and be penalized with a floor fine of 5,000 RMB yuan and a ceiling fine of 20,000 RMB yuan; for serious cases constituting a crime, the person (s) shall be prosecuted for criminal offence according to law.

Article 80  Drug manufacturing enterprises, drug distributing enterprises or medical institutions, which violate the provisions of Article 34 of this Law and purchase drugs from the enterprises without a Drug Manufacturing License or Drug distributing License, shall be ordered to put things right and have their purchased drugs confiscated, and a floor fine two times and ceiling fine five times, respectively, the price of the drug shall be imposed. Where there are illegal gains, these gains shall be confiscated. The Drug Manufacturing License or Drug distributing License shall be revoked for serious cases.

Article 81  Those who import drugs with Import Drug License but do not report for registration and documentation according to the provisions of this Law to the local drug regulatory authority in which the import port is located, shall be served a warning and ordered to put things right within a given time limit. For those who do not comply with the penalty within the time limit, their Import Drug License shall be revoked.

Article 82  Those who forge, convert, buy/sell, lease or lend licenses or drug approval documents shall have their illegal gains confiscated and a floor fine one time and ceiling fine three times, respectively, the illegal gains shall be imposed. For serious cases, the Drug Manufacturing License, Drug Distributing License, Drug Dispensing Permit or the drug approval documents of the buyers, releasers and lenders shall be revoked; for serious case constituting a crime, the persons shall be prosecuted for criminal offence according to law.

Article 83  Those who violate the provisions of this Law to provide forged certificates, documents, data or samples, to adopt other fraudulent methods to obtain Drug Manufacturing License, Drug Distributing License, Drug Dispensing Permit or drug approval documents, shall have their Drug Manufacturing License, Drug Distributing License, Drug Dispensing Permit or drug approval documents revoked, and their applications shall not be accepted within 5 years, and they shall be penalized with a floor fine of 10,000 RMB yuan and a ceiling fine of 30,000 RMB yuan.

Article 84  The medical institutions which distribute the medicinal preparations dispensed by themselves shall be ordered to put things right with the illegally distributed medicinal preparations being confiscated, and shall be imposed a floor fine one time and ceiling fine three times, respectively, the price of the drug Where there are illegal gains, these gains shall be confiscated.

Article 85  Drug distributing enterprises, which violate the provisions of Article 18 and 19 of this Law, shall be ordered to put things right and be served a warning. The Drug Distributing License shall be revoked for serious cases.

Article 86  The labels and indications of drugs, which do not comply to the provisions of Article 54 this Law, should be corrected and served a warning in addition to being treated as counterfeit or substandard drugs according to law; and the drug approval documents shall be revoked.

Article 87  Drug control institutes issuing forged examination reports, which are serious cases constituting a crime, shall be prosecuted for criminal offence according to law. If the case dose not constitute a crime, the office shall be ordered to put things right and be served a warning, and shall be penalized with a floor fine of 30,000 RMB yuan and a ceiling fine of 50,000 RMB yuan. The persons directly in charge of and those directly involved in such activities shall be punished with a lowering of rank, removal from post, or dismissal, and penalized with a ceiling fine of 30,000 RMB yuan Where there are illegal gains, these gains shall be confiscated. The examination qualification shall be recalled for serious cases. Drug control institutes, which issue forged examination reports, shall assume appropriate liabilities for profit losses caused by the incorrect examination report they issued.

Article 88  The decision to mete out administrative penalties stipulated by the provisions from Article 73 to 87 of this Law shall be made by the drug regulatory authority above the county level according to the responsibilities specified by the national drug regulatory authority; The decision to revoke Drug Manufacturing License, Drug Distributing License, Drug Dispensing Permit or drug approval documents shall be made by the original organization, which issued the license or grant the approval.

Article 89  Those who violate the provisions of Article 55, 56, and 57 of this Law related to price control of drugs, shall be penalized according to the Price Law of the People's Republic of China.

Article 90  Drug manufacturing enterprises, drug distributing enterprises and medical institutions, who confer and accept brokerage in secret in drug purchasing/selling, as well as drug manufacturing, or distributing enterprises or their agents, who give presents and other benefits to the person (s) in charge, drug buyers and physicians of medical institutions who have used their drugs, shall be penalized with a floor fine of 10,000 RMB yuan and a ceiling fine of 200,000 RMB yuan by the administrative authorities for industry and commerce. Where there are illegal gains, these gains shall be confiscated. The administrative authorities for industry and commerce shall revoke the Business License of the drug manufacturing or distributing enterprise and notice the drug regulatory authority, which shall revoke Drug Manufacturing License or Drug Distributing License. For the serious cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.

Article 91  Personnel of drug manufacturing or distributing enterprises like the persons in charge or drug buyers, who accept presents or other benefits from other manufacturing or distributing enterprises or their agents in drug purchasing/selling, shall be penalized according to law and their illegal gains shall be confiscated. In serious cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.
          Personnel like the persons in charge, drug buyers and physicians of medical institutions, who accept presents or other benefits from drug manufacturing or distributing enterprises or their agents in drug purchasing/selling, shall be punished by the health administrative authority or the organization where the persons worked, and have the illegal gains confiscated. The physicians with serious offences shall have their practicing license revoked. For serious cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.
         
Article 92  Those who violate the provisions of this Law related to the control of drug advertising, shall be punished according to the provisions of the Advertising Law of the People's Republic of China, and their advertiseing approval numbers shall be revoked by the drug regulatory authority which issued the number. No application for the advertising of the said drug shall be accepted within 1 year. For serious cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.

      The person directly in charge and other persons directly involved in such activities as approving advertisements with forged contents or other factors against laws and administrative regulations without performing censoring duties for drug advertising control according to law, shall be given an administrative penalty by the drug regulatory authority. For the serious cases constituting a crime, the persons shall be prosecuted for criminal offence according to law.

Article 93  Drug manufacturing enterprises, drug distributing enterprises and medical institutions, who violate this Las by doing harm to drug users, shall be held liable for making up for the losses incurred.

Article 94  Any drug regulatory authority committing one of the following acts violating the provisions of this Law shall be ordered by the superior authority or the supervising organ to withdraw the illegally issued certificates and drug approval documents. The person directly in charge and other persons directly involved shall be given an administrative penalty according to law. For the serious cases constituting a crime, the person (s) shall be prosecuted for criminal offence according to law:
(1) issuing certificates to the enterprises which are not qualified for GMP and GSP, or not carrying out follow-up examinations of the enterprises which have obtained the certificates according to regulations;
(2) issuing Drug Manufacturing License, Drug Distributing License or Drug Dispensing License to the organizations which do not have qualifications according to law;
(3) issuing Import Drug License for the drugs which do not pass importing qualifications;
(4) approving clinical trails, granting New Drug Approval Document or Drug Approval Number to the organizations not qualified for clinical trials or production.
     
Article 95  Drug regulatory authorities, drug control institutes established by them, or drug examination organization authorized by the drug regulatory authority which engage in drug producing or distributing activities, shall be ordered to put things right by the superior authority or the supervising organ. Where there are illegal gains, these gains shall be confiscated. The person directly in charge and other persons directly involved shall be given an administrative penalty according to law if the cases are serious.
      Staff of drug regulatory authorities, drug control institutes established by them, or drug examination organization authorized by them, which are involved in drug producing or distributing activities, shall be given an administrative penalty according to law.

Article 96  Drug regulatory authorities or drug control institutes established and authorized by them, which illegally overcharge examination fees in supervising and examining exercises, shall be ordered to return the charge by the appropriate authority of the government. The person directly in charge and other persons directly involved shall be given an administrative penalty according to law. The examination qualification of the drug control institutes shall be recalled in serious cases of illegal overcharging examination fees.

Article 97  The drug regulatory authority shall perform supervising and inspecting duties according to law, and supervise the drug producing and distributing activities of the enterprises which have obtained Drug Manufacturing Licenses or Drug Distributing Licenses.
     Drug manufacturing or distributing enterprises with Drug Manufacturing Licenses or Drug Distributing Licenses, who engage in producing or distributing counterfeit or substandard drugs, shall be imposed an administrative penalty on the person directly in charge and other persons directly involved according to law. For the serious cases constituting a crime, the person (s) shall be prosecuted for criminal offence according to law.

Article 98  The drug regulatory authority shall order the subordinate drug regulatory authorities to correct their illegal administrative activities against this Law within a given time limit; and the drug regulatory authority shall have the rights to change or recall administrative activities of the subordinate drug regulatory authorities, when the corrections can not be made within the time limit.

Article 99  Drug administrators and supervisors, who go in for abusing authority, embezzling and scrimshanking constituting a crime, shall be prosecuted for criminal offence according to law. Those who do not commit a crime shall be given an administrative penalty according to law.

Article 100  The cases of Drug Manufacturing License or Drug Distributing License being revoked shall lead to the alteration or logging out of registration by the administrative authority of commerce and industry after receiving notice from the drug regulatory authority.

Article 101  The drug prices discussed in this chapter refer to the marked prices of the illegally produced or distributed drugs; and shall be calculated on the basis of the market price of the same products when there is no marked price for reference. 

CHAPTER X
SUPPLEMENTARY PROVISIONS
 
Article 102  For the purpose of this Law, the definitions of the some terms are explained as follows:
"Drugs" mean articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposed regulation of human physiological functions, for which indications, actions, usage and dosage are prescribed, including traditional Chinese medicinal herbs, its processed pieces and preparations, chemical ingredients and their preparations, antibiotics, biochemical drugs, radiopharmaceuticals, sera and vaccines, blood products and diagnostic aids, etc.
       "Adjuvant" means the excipients and additives used for the production and dispensing of drugs.
"Drug manufacturing enterprise" means an enterprise exclusively or partly engaged in the production of drugs.
       "Drug distributing enterprise" means an enterprise exclusively or partly engaged in the distributing of drugs.

Article 103  The measures for managing the cultivation, collection and breeding of traditional Chinese medicinal herbs shall be enacted by the State Council separately.

Article 104  The circulation of biological products for preventing diseases shall be controlled by the state. The detailed measures shall be enacted by the State Council.

Article 105  The provisions for the implementation of this Law by the People's Liberation Army of China shall be enacted by the State Council and the Central Military Committee.

Article 106  This Law shall come into force on December 1, 2001.

Explanations on Major Articles of the Detailed Rules of Drug Administration Law

(from http://ccpie.haoyisheng.com)

Deutsche Ausführung

Pharmazeutisches Verwaltung Gesetz die VolksRepublik von China

Der Erlaß des Präsidenten von der VolksRepublik von China (Nr.5)

Das Pharmazeutische Verwaltung Gesetz die VolksRepublik von China wurde revidiert und angenommen am 28. Februar 2001 an der Zwanzigsten Sitzung des Stehenden Komitees vom der Neunten Nationale Volks Congress, und die revidierte Ausführung ist hiermit verkündt. Dieses Gesetz wird in Kraft am 1. Dezember  2001 eintragen.

JIANG ZEMIN
Präsident die VolksRepublik von China
28. Februar 2001
(Angenommen an der Siebten Sitzung dem Stehenden Komitee vom Fünften Nationale Leute Congress am 20. September 1984. Ergänzt an der Zwanzigsten Sitzung dem Stehenden Komitee vom Neunten Nationale Leute Congress am 28. Februar 2001.)