Laws & Regulations/
Drug Administration Law of the People's Republic of China

(No. 45)

The Drug Administration Law of the People’s Republic of China,revised at the 20th Meeting of the Standing Committee of the Ninth National People’sCongress on February 28, 2001, is hereby promulgated and shall go into effectas of December 1, 2001.

                                                 Jiang Zemin

                                                     President of the People’s Republic of China
                                                    February 28, 2001


DRUG ADMINISTRATION LAW OF THE PEOPLE’S REPUBLIC OF CHINA

  (Adopted at the 7th Meeting of the StandingCommittee of the Sixth National  Peoples Congress on September 20,1984, revised at the 20th Meeting of the Standing Committee of  the NinthNational Peoples Congress on February 28, 2001)

CONTENTS

Chapter I  General Provisions
ChapterII   Control over Drug Manufacturers
ChapterIII   Control over Drug Distributors
ChapterIV   Control over Pharmaceuticals in Medical Institutions
ChapterV    Control over Drugs
ChapterVI   Control over Drug Packaging
ChapterVII   Control over Drug Pricing and Advertising
Chapter VIII  Inspection of Drugs
ChapterIX    Legal Liabilities
ChapterX     Supplementary Provisions

Chapter I
General Provisions

Article 1 This Law is enacted to strengthen drugadministration, to ensure drug quality and safety for human beings, to protectthe health of people and their legitimate rights and interests in the use ofdrugs.

Article 2 All institutions and individualsengaged in research, production, distribution, use, or drug administration inthe People’s Republic of China shall abide by this Law.

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

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

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

Article 5 The drug regulatory department underthe State Council shall be responsible for drug administration nationwide. Therelevant departments under the State Council shall be responsible for therelated administrative work within the limits of their duties.

The drug regulatory departments of the people’s governments ofprovinces, autonomous regions, and municipalities directly under the CentralGovernment shall be responsible for drug regulation in their administrativeareas. The relevant departments of the said people’s governments shall beresponsible for the related regulatory work within the limits of their duties.

The drug regulatory department under the State Council shallcooperate with the competent departments for comprehensive economicadministration under the State Council in implementing pharmaceuticaldevelopment programs and policies formulated by the State for thepharmaceutical industry.

Article 6 The drug testing institutesestablished or designated by drug regulatory departments shall undertake theresponsibility for drug testing required for conducting drug review andapproval and controlling drug quality in accordance with law.

Chapter II
Control over Drug Manufacturers

Article 7 The establishment of a drugmanufacturer shall be subject to approval by the local drug regulatorydepartment of the people’s government of the province, autonomous region ormunicipality directly under the Central Government and be granted the DrugManufacturing Certificate, and, with the certificate, the manufacturer shall beregistered with the administrative department for industry and commerce. No onemay manufacturer drugs without the certificate.

The valid term and the scope of manufacturing shall beindicated in the Drug Manufacturing Certificate. For renewal of the certificateon expiration, reexamination is required.
When giving approval to the establishment of a new manufacturer, the drugregulatory department shall see to it that, apart from the requirementsspecified by the provisions in Article 8 of this Law that should be met, thepharmaceutical development programs and policies formulated by the State for thepharmaceutical industry are conformed to and prevent duplicate construction.

Article 8 A drug manufacturer to be establishedshall meet the following requirements:
(1) having legally qualified pharmaceutical and engineering professionals, andthe necessary technical workers;

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

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

(4) having rules and regulations to ensure the quality ofdrugs.

Article 9 Drug manufacturers shall conductproduction according to the Good Manufacturing Practice for PharmaceuticalProducts (GMP) formulated by the drug regulatory department under the StateCouncil on the basis of this Law. The drug regulatory department shall inspecta drug manufacturer as to its compliance with the GMP requirements and issue acertificate to the manufacturer passing the inspection.

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

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

Prepared slices of Chinese crude drugs shall be processed inconformity with the national drug standards. Those not covered by the nationaldrug standards shall be produced according to the processing proceduresformulated by the drug regulatory department of the people’s government of theprovince, autonomous regions, or municipality directly under the CentralGovernment. The said processing procedures shall be submitted to the drugregulatory department under the State Council for the record.

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

Article 12 Drug manufacturers shall performquality test of the drugs produced; no drugs that do not meet the national drugstandards or that are not produced according to the processing procedures forthe prepared slices of Chinese crude drugs formulated by the drug regulatorydepartment of the people’s government of the province, autonomous region, ormunicipality directly under the Central Government may be released.

Article 13 A drug manufacturer may accept contractproduction of drugs upon approval by the drug regulatory department under theState Council, or by the drug regulatory department of the people’s governmentof a province, autonomous region, or municipality directly under the CentralGovernment authorized by the drug regulatory department under the StateCouncil. ( More >> )