Acceptance and Examination of Chemical APIs - Trial Guidelines (Draft) Issued

Acceptance and examination of chemical APIs trial guidelines have had its first draft issued in April 2020. The trial guideline is expected to be finalized and come into effect soon. The guideline will improve the precision in preparing the dossier and reduce the time needed for the application.

On February 8, 2022, the CDE (Centre for Drug Evaluation) issued the second draft to supplement the Administrative Measures for Drug Registration (No.27-2020).

Highlights - Acceptance and examination of chemical APIs

• The scope is adjusted to be applicable for the registration of APIs only.

• Added supporting document requirements in terms of product design validation, product registration number, etc.

• Standardized format and size of the CD-Rom for submission and facilitation of data management.

By Yu Fang and Jacky Li. Contact Cisema if you would like to learn more.