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

Chapter 1 General Provisions Article 1 This law is formulated in order to strengthen drug supervision and management, ensure drug quality, ensure the safety of human drug use, and safeguard the people's legitimate rights and interests in health and drug use.

Article 2 Units or individuals engaged in the development, production, operation, use, supervision and management 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 their role in prevention, medical treatment and health care.

The state protects wild medicinal resources and encourages the cultivation of traditional Chinese medicinal materials.

Article 4: The state encourages the research and creation of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.

Article 5 The drug regulatory department of the State Council is responsible for the national drug regulatory work.

Relevant departments under the State Council are responsible for drug-related supervision and management within their respective scope of responsibilities.

The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and administration of drugs within their respective administrative regions.

Relevant departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for drug-related supervision and management within the scope of their respective responsibilities.

The drug regulatory department of the State Council shall cooperate with the comprehensive economic department of the State Council to implement the development plan and industrial policies for the pharmaceutical industry formulated by the state.

Article 6 The drug inspection institution established or determined by the drug regulatory department shall be responsible for the drug inspection work required to implement drug approval and drug quality supervision and inspection in accordance with the law.

Chapter 2 Management of Pharmaceutical Manufacturing Enterprises Article 7 To establish a pharmaceutical manufacturing enterprise, it must be approved by the pharmaceutical regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located and issued a "Drug Production License".

The management department handles registration.

Without a "Drug Production License", no drugs may be produced.

The "Drug Production License" should indicate the validity period and production scope, and the license will be re-examined and issued upon expiration.

When the drug regulatory department approves the establishment of a drug manufacturing enterprise, in addition to the conditions stipulated in Article 8 of this Law, it must also comply with the drug industry development plan and industrial policy formulated by the state to prevent duplication of construction.

Article 8 To establish a pharmaceutical manufacturing enterprise, the following conditions must be met: (1) Have pharmaceutical technicians, engineering technicians and corresponding technical workers who have been qualified in accordance with the law; (2) Have factories, facilities and sanitary facilities suitable for its pharmaceutical production

environment; (3) having institutions, personnel and necessary instruments and equipment capable of quality management and quality inspection of the drugs produced; (4) having rules and regulations to ensure the quality of drugs.

Article 9: Drug manufacturing enterprises must organize production in accordance with the "Good Manufacturing Practices for Drugs" formulated by the drug regulatory department of the State Council in accordance with this law.

The drug regulatory department shall certify whether drug manufacturers meet the requirements of the Good Manufacturing Practice for Drugs in accordance with regulations; and issue certification certificates to those that pass the certification.

The specific implementation methods and implementation steps of the "Good Manufacturing Practice for Drugs" shall be stipulated by the drug regulatory department of the State Council.

Article 10: Except for the processing of traditional Chinese medicine pieces, drugs must be produced in accordance with national drug standards and production processes approved by the drug regulatory department of the State Council, and production records must be complete and accurate.

If a pharmaceutical manufacturer changes the production process that affects drug quality, it must report to the original approval department for review and approval.

Traditional Chinese medicine pieces must be processed in accordance with national drug standards; if there are no national drug standards, they must be processed in accordance with the processing specifications formulated by the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.

The processing specifications formulated by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall be reported to the drug regulatory department of the State Council for filing.

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

Article 12 Drug manufacturers must conduct quality inspections on the drugs they produce; drugs that do not meet national drug standards or are not processed in accordance with the processing specifications of traditional Chinese medicine pieces formulated by the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall not leave the factory.

Article 13 With the approval of the drug regulatory department of the State Council or the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the State Council authorized by the drug regulatory department of the State Council, a pharmaceutical manufacturer may accept entrustment to produce drugs.

Chapter 3 Management of Pharmaceutical Business Enterprises Article 14 The establishment of a pharmaceutical wholesale enterprise must be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located and a "Pharmaceutical Business License" must be issued;

The local drug supervision and administration department at or above the county level approves and issues a "Pharmaceutical Business License", and you can go to the industrial and commercial administration department for registration with the "Pharmaceutical Business License".

Without a "Pharmaceutical Business License", no pharmaceuticals are allowed to be sold.

The "Pharmaceutical Business License" shall indicate the validity period and business scope, and the license shall be re-examined and issued upon expiration.

When approving the establishment of a drug trading enterprise, the drug regulatory department shall, in addition to complying with the conditions stipulated in Article 15 of this Law, also adhere to the principles of rational layout and convenience for the public to purchase drugs.