In order to further implement the relevant requirements of the Drug Administration Law, the regulations for the implementation of the Drug Administration Law, and the measures for the Administration of Drug Registration on the management of chemical raw materials, we hereby further clarify the issuance of approval notices for chemical raw materials and the management of re-registration. The announcement is as follows:

General 1. requirements

(I) chemical raw materials are managed in accordance with drugs, and their registration, supplementary applications and re-registration applications are administrative licensing matters. The drug regulatory authorities carry out review and approval in accordance with the relevant provisions of the Drug Administration Law, the Implementation Regulations of the Drug Administration Law, and the Measures for the Administration of Drug Registration. The registrant of domestic production of chemical raw materials shall be the actual production enterprise of chemical raw materials, and the registrant of overseas production of chemical raw materials shall entrust an enterprise legal person within the territory of China to register.

Issuance of Notification of Approval for 2. Chemical APIs

After the registration of (II) chemical bulk drugs, if they pass the related review or individual review, a notice of approval for the listing application of chemical bulk drugs and the approved production process, quality standards and labels shall be issued. The notice of approval and the original approval document for the registration of chemical bulk drugs shall be the approval documents for the listing application of chemical bulk drugs. If the review fails, a notice of disapproval shall be issued.

For chemical raw materials that are transferred to the registration platform in accordance with the requirements of the Announcement of the State Food and Drug Administration on Further Improving the Relevant Matters of Drug Related Review, Approval and Supervision (No. 56 of 2019), if there is already a drug approval number (including the registration number of imported drugs, the same below), no notice of approval of chemical raw materials will be issued.

The notice of approval of (III) chemical raw materials shall specify the registration number, name of chemical raw materials, registration standard number, validity period of chemical raw materials, manufacturer, production address, validity period of the notice and other information. The validity period of the notice of approval of chemical raw materials is 5 years, counting from the date of approval.

If the (IV) approves the supplementary application for chemical bulk drugs, it shall issue a notice of approval for the supplementary application for chemical bulk drugs, stating the registration number, original notification number or approval number, name of chemical bulk drugs, registration standard number, application content, approval conclusion, production enterprise, production address and other information, as well as the production process, quality standard and label (if any) approved by the supplementary application.

3. Chemical API Re-registration

(V) domestic production of chemical raw materials by the local provincial drug regulatory authorities to carry out re-registration, overseas production of chemical raw materials by the State Drug Administration Drug Evaluation Center (hereinafter referred to as the drug review center) to carry out re-registration. Chemical raw materials that have obtained the drug approval number shall be re-registered based on the original approval certificate; chemical raw materials that have not obtained the drug approval number and have passed the review and approval mark as "A" shall be re-registered based on the issued chemical raw material approval notice. The registrant of chemical raw materials shall apply to the provincial drug regulatory department (or drug examination center) for re-registration 6 months before the expiration of the drug approval number or the validity period of the chemical raw material approval notice. If the examination is passed, a re-registration approval notice shall be issued; if the examination fails, a notice of disapproval shall be issued.

The preparation is selected from the chemical raw material drug that has not been registered on the raw and auxiliary package registration platform and the relevant research data is submitted together with the application for registration of the drug preparation. After the approval of the related review, the re-registration of the chemical raw material drug is completed together with the related preparation.

(VI), in order to carry out the re-registration of chemical raw materials in an orderly manner, a certain transition period is given. From the date of this announcement, if the remaining validity period of the chemical bulk drug approval certificate is more than 6 months, apply for re-registration in accordance with the provisions of item (V) above; if the remaining validity period of the approval certificate is less than 6 months or has expired, the registrant shall Within one year from the date of this announcement, submit an application for re-registration to the provincial drug regulatory authority (or drug review center).

During the transitional period, the registrant may make a supplementary application or record for the post-marketing change of the chemical API.

If the (VII) passes the review of the application for re-registration of chemical bulk drugs, the original and auxiliary package registration platform will still retain the "A" mark; If the review fails, the identification of chemical bulk drugs shall be adjusted from "A" to "I"; For those who fail to apply for re-registration within the validity period of the approval certificate or the above-mentioned transition period, the identification of chemical bulk drugs shall be adjusted from "A" "; if the application has been made on schedule but the review has not been completed, and the approval documents have exceeded the validity period, a statement of" re-registration review "shall be added to the remarks column of the registration item of the chemical bulk drug.

(VIII) provincial drug regulatory authorities will timely push the re-registration declaration and approval information of domestic production of chemical raw materials and the filing information of changes after listing to the registration platform, which will be related to the registration information of the chemical raw materials, and the platform will timely update the validity period information of the approval certificate of the chemical raw materials.

4. on the cancellation of chemical bulk drug approval documents.

If the (IX) registrant voluntarily applies for cancellation of the approval documents of chemical bulk drugs that have passed the review and approval, the domestic production chemical bulk drug registrant shall submit the materials to the provincial drug regulatory department where it is located, and the provincial drug regulatory department shall submit a written letter to the drug examination center to apply for cancellation; The registrar of chemical bulk drugs produced abroad directly submits a written letter to the drug examination center to cancel the approval documents of the chemical bulk drugs according to the procedures.

For domestic production chemical bulk drugs that have not passed the re-registration review and approval, after the provincial drug regulatory department makes a decision not to re-register, the drug review center will timely adjust the identification as "I" according to the approval results pushed by the provincial drug regulatory department. At the same time, the provincial drug regulatory department will send a written letter to the drug review center to cancel the approval certificate of the chemical bulk drugs. Re-registration review and approval failed overseas production of chemical bulk drugs, after the drug examination center makes a decision not to re-register, it shall timely adjust the identification as "I" and cancel the approval certificate of the chemical bulk drug according to the procedure. After the cancellation is completed, it shall be marked as "canceled" on the registration platform of the original and auxiliary package ".

This announcement shall come into force as of the date of publication.

It is hereby announced.