Drug Administration Law of the People's Republic of China (Revised in 2001)

Drug Administration Law of the People's Republic of China (Revised in 2001)

Drug Administration Law of the People's Republic of China (Revised in 2001)

Order of the President of the People's Republic of China No.45

February 28, 2001

Adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984
Revised at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001

Contents
Chapter I General Provisions
Chapter II Administration over Drug Manufacturers
Chapter III Administration over Drug Distributors
Chapter IV Administration over Pharmaceuticals in Medical Institutions
Chapter V Administration over Drugs
Chapter VI Administration over Drug Packaging
Chapter VII Administration over Prices and Advertisements of Drugs
Chapter VIII Supervision over Drugs
Chapter IX Legal Liabilities
Chapter X Supplementary Provisions

Chapter I General Provisions

Article 1 The Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Law") is enacted to strengthen drug supervision and administration, to ensure drug quality and safety for human beings, and to protect the health of the people and their legitimate rights and interests in the use of drugs.

Article 2 All entities and individuals engaged in research, production, distribution and use of, and supervision and administration over, drugs within the territory of the People's Republic of China shall abide by the 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 traditional Chinese drugs.

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

Article 5 The drug regulatory department under the State Council is responsible for drug supervision and administration nationwide. The relevant departments under the State Council are responsible for the supervision and administrative work related to drugs within the limits of their duties.
The drug regulatory departments of the people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government are responsible for drug supervision and administration in their respective administrative areas. The relevant departments of the said people's governments are responsible for the supervision and administrative work related to drugs 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 institutions established or designated by drug regulatory departments undertake the responsibility for drug testing required for conducting drug review and approval and supervising and inspecting drug quality in accordance with the law.

Chapter II Administration over Drug Manufacturers

Article 7 The establishment of a drug manufacturer shall be subject to the approval from the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the manufacturer to be established is located and be granted a Drug Manufacturing Certificate, on the strength of which the manufacturer shall get registered with the administrative department for industry and commerce, and without which no one is allowed to manufacture drugs.
The valid term and the scope of manufacturing shall be indicated in a Drug Manufacturing Certificate. For renewal of the certificate upon expiration, reexamination is required.
When giving approval to the establishment of a drug manufacturer, the drug regulatory department shall see to it that, apart from the requirements specified by the provisions in Article 8 of the Law that shall be met, the pharmaceutical development programs and policies formulated by the State for the pharmaceutical industry are complied with so as to 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 corresponding technical workers;
2. having the premises, facilities, and hygienic environment required for drug manufacturing;
3. having the institutions and personnel capable of quality management and testing for drugs to be produced thereby and the necessary instruments and equipment; and
4. having rules and regulations to ensure the quality of drugs.

Article 9 Drug manufacturers shall conduct production in accordance with the Good Manufacturing Practice for Drugs formulated by the drug regulatory department under the State Council based on the Law. The drug regulatory departments shall inspect a drug manufacturer for its compliance with the requirements of the Good Manufacturing Practice for Drugs in accordance with the relevant provisions and issue a certificate to the manufacturer passing the inspection.
The specific measures and schedule for implementing the Good Manufacturing Practice for Drugs shall be formulated by the drug regulatory department under the State Council.

Article 10 With the exception of the processing of prepared slices of traditional Chinese drugs, a drug shall be produced in conformity with the national drug standards 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 change for examination and approval to the original approval authority.
Prepared slices of traditional Chinese drugs shall be processed in conformity with the national drug standards. Those not covered by the national drug standards shall be processed in accordance with the processing norms formulated by the drug regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government. The said processing norms shall be submitted to the drug regulatory department under the State Council for the record.

Article 11 The crude materials and accessories for manufacturing drugs shall meet the requirements for medicinal use.

Article 12 Drug manufacturers shall perform quality test of the drugs produced thereby; no drugs that do not meet the national drug standards or that are not produced in accordance with the processing norms for the prepared slices of traditional Chinese drugs formulated by the drug regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government may be released from the plants.

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 Administration over Drug Distributors

Article 14 The establishment of a drug wholesaler shall be subject to approval from and be granted a Drug Distribution Certificate by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the wholesaler to be established is located; the establishment of a drug retailer shall be subject to approval from and be granted a Drug Distribution Certificate by the local drug regulatory department at or above the country level. With a Drug Distribution Certificate, the wholesaler and the retailer shall get registered with the administrative department for industry and commerce. No one is allowed to distribute drugs without a Drug Distribution Certificate.
The valid term and the scope of business shall be indicated in a Drug Distribution Certificate. For renewal of the certificate upon expiration, reexamination is required.
When giving approval to the establishment of a drug distributor, the drug regulatory departments shall see to it that, apart from the requirements specified by the provisions in Article 15 of the Law that shall be met, the principles of appropriate location and convenient purchase of drugs by the people are adhered to.

Article 15 A drug distributor to be established shall meet the following requirements:
1. having legally qualified pharmaceutical professionals;
2. having the business premises, equipment, warehouses and hygienic environment required for drug distribution;
3. having the institutions or personnel for quality management for the drugs to be distributed; and
4. having rules and regulations to ensure the quality of the drugs to be distributed.

Article 16 Drug distributors shall conduct drug distribution in accordance with the Good Distribution Practice for Drugs formulated by the drug regulatory department under the State Council based on the Law. The drug regulatory departments shall inspect a drug distributor for its compliance with the requirements of the Good Distribution Practice for Drugs, and issue a certificate to the distributor passing the inspection.
The specific measures and schedule for implementing the Good Distribution Practice for Drugs shall be formulated by the drug regulatory department under the State Council.

Article 17 For purchase of drugs, drug distributors shall establish and apply an examination and acceptance system for the drugs to be purchased, and check the certificate of drug quality and other marks; no drug that fails to meet the prescribed requirements may be purchased.

Article 18 When purchasing and selling drugs, drug distributors shall keep authentic and complete records of purchase and sale, wherein the common name, dosage form, specification, batch number, term of validity, manufacturer, purchaser (or seller), amount of the drugs purchased (or sold), purchase or sale price, date of purchase (or sale), and other items about the drugs specified by the drug regulatory department under the State Council shall be indicated.

Article 19 Drug distributors shall sell drugs correctly without errors and make a correct description of usage, dosage and cautions; prescriptions being dispensed shall be checked, and no drugs listed therein may be changed or substituted without authorization. They shall refuse to dispense incompatible or over-dose prescriptions; when necessary, they may do so only after corrections or re-signing by the prescribing physicians.
Drug distributors shall indicate the origin of the traditional Chinese drugs to be sold.

Article 20 A drug distributor shall establish and apply a system for drug storage, and take necessary measures to ensure the quality of drugs, such as cold storage, protection against freeze and humidity and avoidance of insects and rodents.
An examination system shall be applied for placing drugs in and releasing them from storage.

Article 21 Traditional Chinese drugs may be sold on urban and rural trade markets, except as otherwise specified by the State Council.
No drugs other than the traditional Chinese drugs may be sold on urban and rural trade markets, but drug retailers holding a Drug Distribution Certificate may, within the specified scope, sell such drugs at stores they set up on the urban and rural trade markets.
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