Each port (border port) drug supervision and management department:

According to the "Notice of the General Office of the General Office of the General Administration of Food and Drug Administration on Issuing the Appraisal and Assessment Program for the Establishment of Additional Ports Allowed for Drug Imports" (Food and Drug Administration (2015) No. 134), the General Office of the General Administration of Food and Drug Administration The Notice on the Implementation of Evaluation and Assessment Implementation Plan for the Establishment of Additional Drug Import Ports (Food and Drug Administration and Drug Huaguan [2016] No. 150) and other relevant regulations were issued. The State Drug Administration organized the drafting of the "First Drug Import Port Evaluation Standard". To be issued. The port drug supervision and administration department may submit the first drug import port application to the State Drug Administration based on drug import requirements.

National Food and Drug Administration

December 30, 2019

The first drug import port evaluation standard

1. The application for adding the first import port of drugs (excluding medicinal materials) should match the demand. Where a free trade zone has been established in the region or the local government has set up a biomedical industry park, there is a clear plan involving the biomedical industry, and the biomedical enterprises in the region have proposed a clear first-time drug import demand.

2. The port drug inspection agency applying for the first import of drugs should have no less than 3 domestic and foreign experts who can understand and master the latest foreign drug technical standards (such as the World Health Organization, the United States Pharmacopoeia, European EDQM experts, etc., domestic Pharmacopoeia committee members, International GMP inspectors, etc.).

3. The port drug inspection agency applying for the first import of drugs should have research experience in scientific research projects related to national standards. Have research work experience in international drug standards (foreign pharmacopoeia standards) and at least 50 domestic drug standards research work experience (including national pharmacopoeia standards and national drug registration standards).

4. The port drug inspection agency applying for the first import of drugs has participated in the proficiency verification and comparison test organized by domestic authoritative institutions (China National Accreditation Service for Conformity Assessment, China Food and Drug Control Institute, etc.) at least 10 times in the past three years, and participated in international authoritative institutions (World Health Organization, International Pharmaceutical Federation, European Medicines Quality Agency, etc.) organized proficiency testing tests at least 2 times, and all should be satisfactory.

5. The inspection and testing capabilities of the port drug inspection agency applying for the first import of drugs should meet the requirements of drug port inspection and have the ability to cover all items included in the domestic and foreign pharmacopoeia standards. In the past five years, the number of domestic and foreign standards that involved full inspection of various drug inspection tasks was not less than 100, of which the number of imported drug standards was not less than 30 (including port inspection of imported drugs, supervision and sampling, and drug standard review work).

6. The port drug inspection agency applying for the first import of drugs should have independent scientific research capabilities, and the agency should have undertaken relevant research projects at or above the provincial and ministerial level.