In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council (Ting Zi [2017] No. 42) and the "Decision of the State Council on Canceling a Batch of Administrative Licensing Items" ( Guofa [2017] No. 46), cancel the examination and approval of pharmaceutical excipients and packaging materials and containers that directly contact drugs (hereinafter referred to as pharmaceutical packaging materials). APIs, pharmaceutical excipients and pharmaceutical packaging materials shall be examined and approved at the same time as the application for registration of pharmaceutical preparations. Review and approve. The relevant matters are hereby announced as follows:

1. The APIs used in the application for registration classifications 2.2, 2.3, 2.4, 3, 4, and 5 of drug preparations submitted by the drug registration applicant in the territory of the People’s Republic of China, as well as the pharmaceutical excipients and drugs used in various drug registration applications Packaging materials are applicable to the requirements of this announcement.

2. Since the date of this announcement, food and drug regulatory authorities at all levels will no longer individually accept registration applications for APIs, pharmaceutical excipients and pharmaceutical packaging materials. The Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Center for Drug Evaluation) ) Establish a registration platform (hereinafter referred to as the registration platform) and database for APIs, pharmaceutical excipients and pharmaceutical packaging materials. Relevant enterprises or units can submit registration materials for APIs, pharmaceutical excipients and pharmaceutical packaging materials through the registration platform according to the requirements of this announcement. Obtain the registration numbers of APIs, pharmaceutical excipients and pharmaceutical packaging materials, and review them together after the registration application is submitted for the related pharmaceutical preparations.

3. The main contents of the registration data of raw materials: basic information, production information, identification of characteristics, quality control of raw materials, reference substances, pharmaceutical packaging materials, stability, etc. The specific content should comply with the "Notice on the Publication of New Registration Classification and Application Data Requirements for Chemical Drugs (Trial)" (CFDA Circular 2016 No. 80).

4. The main contents of the registration materials of pharmaceutical excipients: basic information of the enterprise, basic information of excipients, production information, identification of characteristics, quality control, batch inspection reports, stability studies, pharmacology and toxicology studies, etc. The specific content should comply with the "Notice on Issuing the Requirements for the Application of Pharmaceutical Packaging Materials and Excipients (Trial)" (CFDA Circular 2016 No. 155).

5. The main contents of the registration materials of pharmaceutical packaging materials: basic information of the enterprise, basic information of pharmaceutical packaging materials, production information, quality control, batch inspection reports, stability studies, safety and compatibility studies, etc. The specific content should meet the requirements of the 2016 Announcement No. 155 of Chinese Medicine Packaging Materials.

6. During the transition period of the establishment of the registration platform, the Center for Drug Evaluation will publicize "API registration data", "pharmaceutical excipient registration data", and "pharmaceutical packaging materials" on the portal website (website: www.cde.org.cn) in a form to the society "Registration data", the public information mainly includes: registration number, product name, company name, company registration address, domestic/import, packaging specifications, registration date, update date, approval status of related pharmaceutical preparations, etc.

After the API, pharmaceutical excipients and pharmaceutical packaging materials companies fill in the basic information of the varieties on the "Applicant's Window" on the portal website of the Center for Drug Evaluation, they submit the registration materials (including the registration form, see Annex 1) to the Center for Drug Evaluation in the form of CD-ROM ( Mailing address: Business Management Office of the Drug Evaluation Center, No. 1 Fuxing Road, Haidian District, Beijing). The Center for Drug Evaluation shall conduct a completeness review of the registration materials within 5 working days after receiving the materials. If the information is incomplete, the registration information that needs to be supplemented and corrected will be notified at one time; if the information meets the requirements, the Center for Drug Evaluation will make public announcements.

7. For the registration applications for APIs, pharmaceutical excipients and pharmaceutical packaging materials that have been accepted and have not been approved for review, the Center for Drug Evaluation shall generate the registration numbers of APIs, pharmaceutical excipients and pharmaceutical packaging materials, and import the application information into the above-mentioned registration data After the form, it is publicized to the society. Applicants should submit the application and registration materials to the Center for Drug Evaluation in the form of CDs in accordance with the requirements of this announcement. Newly declared pharmaceutical preparations (including supplementary applications for changed APIs, pharmaceutical excipients and pharmaceutical packaging materials) use APIs, pharmaceutical excipients and pharmaceutical packaging materials with an approved document number. The APIs, pharmaceutical excipients and pharmaceutical packaging materials Packaging materials should also be registered as required.

8. APIs, pharmaceutical excipients and pharmaceutical packaging materials used by the applicant for pharmaceutical preparations only for their own use, or APIs, pharmaceutical excipients and pharmaceutical packaging materials used by the holder of a specific drug marketing authorization, may be submitted at the same time in the pharmaceutical preparation application Data on APIs, pharmaceutical excipients and packaging materials (data requirements refer to this announcement) will not be registered.

9. Applicants for pharmaceutical preparations can select APIs, pharmaceutical excipients and pharmaceutical packaging materials with existing registration numbers for research, and submit applications for marketing or change applications for APIs, pharmaceutical excipients and pharmaceutical packaging materials. If the pharmaceutical preparation is not the same applicant as the API, pharmaceutical excipients and pharmaceutical packaging materials, the applicant for pharmaceutical preparations shall provide in the application materials the authorization to use the API, pharmaceutical excipients and pharmaceutical packaging materials from the holder of the marketing authorization or the enterprise (Annex 2).

10. Enterprises of APIs, pharmaceutical excipients and pharmaceutical packaging materials that have obtained registration numbers shall be managed in strict accordance with relevant national requirements to ensure product quality, and submit product quality management reports annually after obtaining registration numbers; when product changes occur At the time, relevant information should be changed in the registration platform in a timely manner, and the applicant for pharmaceutical preparations using its products should be proactively notified before the implementation of the change.

Applicants for pharmaceutical preparations shall be responsible for the quality of the selected raw materials, pharmaceutical excipients and pharmaceutical packaging materials, and fully study and evaluate the impact of changes in raw materials, pharmaceutical excipients and pharmaceutical packaging materials on their product quality, in accordance with the State Food and Drug Administration Relevant regulations and relevant guiding principles shall be studied, and application for changes or filing shall be made as required.

11. After drug preparations are approved for marketing or after approved changes to APIs, pharmaceutical excipients and pharmaceutical packaging materials (including changes to API suppliers, pharmaceutical excipients and pharmaceutical packaging materials and suppliers), national food and drugs The General Administration of Supervision and Administration shall mark the public information of APIs, pharmaceutical excipients and pharmaceutical packaging materials. Other requirements for the simultaneous review and approval of APIs, pharmaceutical excipients and pharmaceutical packaging materials and pharmaceutical preparations will be implemented after the relevant management measures of the State Food and Drug Administration are issued.

The relevant registration requirements for APIs, pharmaceutical excipients and pharmaceutical packaging materials that have been approved before the issuance of this announcement will be notified separately after the registration platform is established.

12. The provincial food and drug supervision and administration departments are responsible for the daily supervision and management of the raw materials, pharmaceutical excipients and pharmaceutical packaging materials production enterprises within their administrative regions. During the review and approval process of drug preparation applications, the State Food and Drug Administration will organize on-site inspections and inspections of the raw materials, pharmaceutical excipients, and packaging materials involved as needed.

13. This announcement will be implemented as of the date of its release. If the originally issued related documents for the review and approval of the medical excipients and packaging materials are inconsistent with this announcement, this announcement shall prevail.

Special announcement.