中华人民共和国药品管理法（修订） Drug Control Law of the Peoples Republic of China

颁布日期：20010228 　实施日期：20011201 　颁布单位：全国人大常委会

　　Order of the President of The People's Republic of China

　　No.45

　　The Drug Control Law of the People's Republic of China, amended at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28,2001,is hereby promulgated and shall go into effect as of December 4,2001.

　　Jiang Zemin

　　President of the People's Republic of China

　　February 28,2001

　　(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People's Congress on September 20,1984,amended at 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28,2001)

　　Contents

　　Chapter I General Provisions

　　Chapter II Control over Drug Manufacturers

　　Chapter III Control over Drug Distributors

　　Chapter IV Control over Pharmaceuticals in Medical Institutions

　　Chapter V Control over Drugs

　　Chapter VI Control over Drug Packaging

　　Chapter VII Control over Drug Pricing and Advertising

　　Chapter VIII Inspection of Drugs

　　Chapter IX Legal Liabilities

　　Chapter X Supplementary Provisions

　　Chapter I

　　General Provisions

　　Article 1 This Law is enacted to tighten drug control, to ensure drug quality and safety for human beings, to protect the health of people and their legitimate rights and interests in the use of drugs.

　　Article 2 All institutions and individuals engaged in research, production, distribution, use, or control over drugs in the People's Republic of China shall abide by this Law.

　　Article 3 The State develops both modern and traditional medicines to give full play to their role in prevention and treatment of diseases and in maintenance of health.

　　The State protects the resources of natural crude drugs and encourages the cultivation of Chinese crude drugs.

　　Article 4 The State encourages research and development of new drugs and protects the legitimate rights and interests of citizens, legal bodies and other institutions engaged in this field of endeavor.

　　Article 5 The drug regulatory department under the State Council departments under the State Council shall be responsible for the related regulatory work within the limits of their duties.

　　The drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for drug regulation in their administrative areas. The relevant departments of the said people's governments shall be responsible for the related regulatory work within the limits of their duties.

　　The drug regulatory department under the State Council shall cooperate with the competent department for comprehensive economic administration under the State Council in implementing pharmaceutical development programs and policies formulated by the State for the pharmaceutical industry.

　　Article 6 The drug testing institutes established or designated by drug regulatory departments shall undertake the responsibility for drug testing required for conducting drug examination, granting approval and controlling drug quality in accordance with law.

　　Chapter II

　　Control over Drug Manufacturers

　　Article 7 The establishment of a drug manufacturer shall be subject to approval by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative department for industry and commerce. No one may manufacture drugs without the certificate.

　　The valid term and the scope of manufacturing shall be indicated in the Drug Manufactur

ing Certificate. For renewal of the certificate on expiration, reexamination is required.

　　When giving approval to the establishment of a new manufacturer, the drug regulatory department shall see to it that, apart from the requirements specified by the provisions in Article 8 of this Law that should be met, the pharmaceutical development programs and policies formulated by the State for the pharmaceutical industry are conformed to and prevent duplicate construction.

　　Article 8 A drug manufacturer to be established shall meet the following requirements:

　　（1）having legally qualified pharmaceutical and engineering professionals, and the necessary technical workers;

　　（2）having the premises, facilities, and hygienic environment required for drug manufacturing;

　　（3）having the institutions and personnel capable quality control and testing for drugs to be produced and the necessary instruments and equipment; and

　　（4）having rules and regulations ensure the quality of drugs.

　　Article 9 Drug manufacturers shall conduct production according to the Good Manufacturing Practice for Pharmaceutical Products（GMP）formulated by the drug regulatory department under the State Council on the basis of this Law. the drug regulatory department under the State Council on the basis of this Law. The drug regulatory department shall inspect a drug manufacturer as to its compliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection.

　　The specific measures and schedule for implementing the GMP shall be formulated by the drug regulatory department under the State Council.

　　Article 10 With the exception of processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity with the National Drug Standard and with the production processes approved by the drug regulatory department under the State Council, and the production records shall be complete and accurate. When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the matter for examination and approval to the original approval authority.

　　Prepared slices of Chinese crude drugs shall be processes in conformity with the national drug standards. Those not covered by the national drug standards shall be produced according to the processing procedures formulated by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government. The said processing procedures shall be submitted to the drug regulatory department under the State Council for the record.

　　Article 11 The drug substances and excipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal use.

　　Article 12 Drug manufacturers shall perform quality test of the drugs produced; no drugs that do not meet the national drug standards or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the drug regulatory department of the people's government of the province, autonomous region , or municipality directly under the Central Government may be released.

　　Article 13 A drug manufacturer may accept contract production of drugs upon approval by the drug regulatory department under the State Council, or by the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government authorized by the drug regulatory department under the State Council.

　　Chapter III

　　Control over Drug Distributors

　　Article 14 The establishment of a drug wholesaler shall be subject to approval of the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and be granted the

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