On February 9th, CDE issued two registration acceptance review guidelines, involving chemical and biological drugs!

Let's learn about the above guidelines together.

In order to further standardize the requirements for the formal examination of chemical drug registration acceptance and better guide and serve applicants, under the deployment of the National Medical Products Administration, the Drug Evaluation Center has organized the revision of the "Guidelines for the Examination of Chemical Drug Registration Acceptance (Trial)" (see attachment). According to the Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedure for Issuing Drug Technical Guidance Principles (Drug Administration Comprehensive Drug Administration [2020] No. 9), and with the review and approval of the National Medical Products Administration, it is now issued and will come into effect on March 10, 2025.

This is to inform you.

Attachment: Guidelines for Acceptance and Review of Chemical Drug Registration (Trial)

National Medical Products Administration Drug Review Center

February 9, 2025

In order to further standardize the formal examination requirements for the registration and acceptance of biological products, and better guide and serve applicants, under the deployment of the National Medical Products Administration, the Drug Evaluation Center has organized the revision of the "Guidelines for Registration and Acceptance Examination of Biological Products (Trial)" (see attachment). According to the Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedure for Issuing Drug Technical Guidance Principles (Drug Administration Comprehensive Drug Administration [2020] No. 9), and with the review and approval of the National Medical Products Administration, it is now issued and will come into effect on March 10, 2025.

This is to inform you.

Attachment: Guidelines for Registration and Acceptance Examination of Biological Products (Trial)

National Medical Products Administration Drug Review Center

February 9, 2025