The full text of the regulations on the administration of drug imports

The measures for the administration of imported drugs mainly include the following:

1. Classification and approval of imported drugs: Imported drugs are divided into three categories according to their safety, effectiveness and quality levels, namely special management drugs, general management drugs and general management drugs. Imported drugs need to go through an approval process before they can be sold and used in China;

2. Registration and filing of imported drugs: Imported drugs need to be registered or filed in China so that the regulatory authorities can supervise them. The requirements for registration and filing include the quality, safety, effectiveness, production process and quality control of drugs;

3. Quality control of imported drugs: Imported drugs need to meet China's drug quality standards and regulations, and at the same time, quality control and inspection are required. The quality control of imported drugs includes the production, packaging, storage and transportation of drugs;

4. Supervision and traceability of imported drugs: Regulatory authorities need to supervise and trace imported drugs to ensure their quality and safety. Regulatory and traceability requirements include aspects such as the production, sale, use and adverse reactions of drugs;

5. Reporting and punishment of imported drugs: When there are quality problems or adverse reactions of imported drugs, they need to report to the regulatory authorities in a timely manner and accept the corresponding penalties. Penalties can take the form of warnings, fines, suspension of sales, and revocation of registration.

The specific contents of imported drugs include:

1. APIs: Imported APIs are mainly used to manufacture drugs, including chemically synthesized drugs, biological products, natural medicines, etc.;

2. Preparations: Imported preparations refer to drugs that have been made, including tablets, capsules, injections, oral deficiency solutions, external drugs, etc.;

3. Traditional Chinese medicine decoction pieces: imported Chinese medicine decoction pieces refer to Chinese herbal medicines imported from abroad and processed Chinese medicine decoction pieces;

4. Biological products: imported biological products include vaccines, blood products, biological agents, etc.;

5. Chemicals: Imported chemicals are mainly used for cancer, cardiovascular diseases, nervous system diseases, etc.

To sum up, the implementation of the Measures for the Administration of Imported Drugs aims to ensure the quality and safety of imported drugs and promote the healthy development of the domestic drug market.

Legal basis]:

Article 8 of the Measures for the Administration of Imported Drugs.

The Port Drug Administration is responsible for the import filing of drugs. The import filing work undertaken by the Port Drug Administration is under the leadership of the State Food and Drug Administration, and its specific responsibilities include:

1) Accept the application for import filing and review the import filing materials;

2) Matters related to the handling of import filing or non-import filing;

3) Contact the Customs for matters related to import filing;

4) Notify the port drug inspection institute to carry out port inspection of imported drugs;

5) Supervise and deal with the problems found in the import filing and port inspection;

6) Other matters stipulated by the State Food and Drug Administration.