Announcement of the General Administration of the People's Republic of China on Adjusting the Examination and Approval of Raw Materials, Pharmaceutical Excipients and Pharmaceutical Package Materials (No. 146 of 2017)

In order to implement the Opinions of the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices (HJ [2017] No. 42) and the Decision of the State Council on Canceling a Batch of Administrative Licensing Items (GF [2017] No. 46), and cancel the approval of pharmaceutical excipients and packaging materials and containers that directly contact with drugs (hereinafter referred to drug packaging materials), raw materials, pharmaceutical excipients and pharmaceutical packaging materials shall be reviewed and approved together with the application for registration of pharmaceutical preparations. The relevant matters are hereby announced as follows:

The bulk drugs used in the registration classification 2.2, 2.3, 2.4, 3, 4, and 5 drug preparation applications filed by the 1. drug registration applicant in the People's Republic of China, as well as the pharmaceutical excipients and drug packaging materials used in various drug registration applications The requirements of this announcement apply.

2. From the date of this announcement, the food and drug supervision and administration departments at all levels will no longer accept the registration applications of raw materials, pharmaceutical excipients and drug packaging materials separately, and the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Review Center) Establish a registration platform (hereinafter referred to as the registration platform) and database for raw materials, pharmaceutical excipients and drug packaging materials, relevant enterprises or units may submit the registration data of bulk drugs, pharmaceutical excipients and pharmaceutical packaging materials through the registration platform according to the requirements of this announcement, and obtain the registration numbers of bulk drugs, pharmaceutical excipients and pharmaceutical packaging materials, which shall be reviewed together after the registration application of related pharmaceutical preparations is submitted.

The main contents of 3. API registration data: basic information, production information, characteristic identification, quality control of API, reference substance, packaging material, stability, etc. The specific content shall comply with the requirements of the pharmaceutical application materials for raw materials in the Notice on Issuing the Requirements for Classification and Application Materials for New Registration of Chemical Drugs (for Trial Implementation) (Notice No. 80 of 2016 of the State Food and Drug Administration).

The main contents of the registration data of 4. pharmaceutical excipients: basic information of enterprises, basic information of excipients, production information, characteristic identification, quality control, batch inspection report, stability research, pharmacological and toxicological research, etc. The specific content shall comply with the "Notice on Issuing Requirements for Application Materials for Pharmaceutical Accessories for Drug Package Materials (Trial)" (china food and drug administration Notice No. 155 of 2016) requirements for application materials for traditional Chinese medicine.

The main contents of the registration data of 5. drug packaging materials: basic information of enterprises, basic information of drug packaging materials, production information, quality control, batch inspection report, stability study, safety and compatibility study, etc. The specific contents shall meet the requirements of the application materials for drug packaging materials in Circular No. 155 of 2016.

6. during the transition period of the establishment of the registration platform, the drug examination center publicized "bulk drug registration data", "pharmaceutical excipients registration data" and "drug packaging materials registration data" to the society in the form of tables on the portal website (website: www.cde.org.cn). The publicized information mainly includes: registration number, variety name, enterprise name, enterprise registered address, domestic/imported, packaging specification, registration date, update date, approval of related drug preparations, etc.
After filling in the basic variety information in the "Applicant's Window" on the portal website of the Drug Examination Center, the enterprises of bulk drugs, pharmaceutical excipients and pharmaceutical packaging materials will submit the registration data (including the registration form, see Annex 1) to the Drug Examination Center in the form of CD (mailing address: Business Management Office of Drug Examination Center, No.1 Fuxing Road, Haidian District, Beijing). The Drug Examination Center will conduct integrity review of the registration data within 5 working days after receiving the data. If the information is not complete, the registration information that needs to be supplemented shall be notified at one time; If the information meets the requirements, the drug examination center shall publicize it.

7. For applications for registration of APIs, pharmaceutical excipients and pharmaceutical packaging materials that have been accepted without review and approval, the Drug Examination Center will generate the registration numbers of APIs, pharmaceutical excipients and pharmaceutical packaging materials, and will import the application information into the above-mentioned registration data sheet and make it public to the public. The applicant shall submit the application and registration data to the drug examination center in the form of CD according to the requirements of this announcement. The newly declared pharmaceutical preparations (including supplementary applications for changing bulk drugs, pharmaceutical excipients and pharmaceutical packaging materials) use bulk drugs, pharmaceutical excipients and pharmaceutical packaging materials with approval numbers, and the bulk drugs, pharmaceutical excipients and pharmaceutical packaging materials shall also be registered as required.

The applicant for 8. pharmaceutical preparations is only for its own use of raw materials, pharmaceutical excipients and pharmaceutical packaging materials, or for specific drug marketing license holders to use raw materials, pharmaceutical excipients and pharmaceutical packaging materials, can submit the application for pharmaceutical preparations at the same time raw materials, pharmaceutical excipients and pharmaceutical packaging materials data (data requirements refer to this announcement), do not register.

Applicants for 9. pharmaceutical preparations may choose to use APIs, pharmaceutical excipients and pharmaceutical packaging materials with existing registration numbers for research, and apply for listing or change of 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 pharmaceutical preparation applicant shall provide the authorization for use of the API, pharmaceutical excipients and pharmaceutical packaging materials in the application materials (Annex 2).

10. API, pharmaceutical excipients and pharmaceutical packaging materials enterprises that have obtained the registration number shall be managed in strict accordance with the relevant requirements of the state to ensure the product quality, and submit the product quality management report on an annual basis after obtaining the registration number; when the product changes, the relevant information shall be changed in the registration platform in time, and the applicant of the pharmaceutical preparation using the product shall be informed of the change before the change is implemented.
The applicant for pharmaceutical preparation shall be responsible for the quality of the selected raw materials, pharmaceutical excipients and pharmaceutical packaging materials, fully study and evaluate the impact of the changes of raw materials, pharmaceutical excipients and pharmaceutical packaging materials on the quality of their products, conduct research in accordance with the relevant provisions of the State Food and Drug Administration and relevant guiding principles, and submit an application for change or put on record as required.

Eleven, after the drug preparation is approved for marketing or after the listed drug preparation approves the change of bulk drug, pharmaceutical excipients and drug packaging materials (including the change of bulk drug suppliers, types and suppliers of pharmaceutical excipients and drug packaging materials), the State Food and Drug Administration shall mark the public information of bulk drug, pharmaceutical excipients and drug packaging materials. Other requirements for the review and approval of raw materials, pharmaceutical excipients and pharmaceutical packaging materials together with pharmaceutical preparations shall be implemented after the relevant administrative measures of the State Food and Drug Administration are issued.
The relevant registration requirements for API, pharmaceutical excipients and pharmaceutical packaging materials that have obtained the approval number before the announcement will be notified separately after the establishment of the registration platform.

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. In the process of application for review and approval of pharmaceutical preparations, the State Food and Drug Administration shall organize on-site inspection and inspection of the raw materials, pharmaceutical excipients and pharmaceutical packaging materials involved as needed.

13, This announcement shall be implemented as of the date of promulgation. If the relevant documents for the related review and approval of pharmaceutical excipients are inconsistent with this announcement, this announcement shall prevail.

It is hereby announced.