On February 8, 2022, the CDE (Centre for Drug Evaluation) issued the second draft guideline for the trial acceptance and examination of chemical APIs to supplement the Administrative Measures for Drug Registration (No.27-2020).
Since the first draft was 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.
Highlights
- 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.
