On Oct. 14, 2022, China National Medical Products Administration (NMPA) announced it would temporarily extend the deadlines for drug registration applicants to submit supplemental documents.
If finding applications deficient, NMPA will issue deficiency letters that require relevant applicants to submit supplemental documents.
Here are the detailed extensions:
Provisional Extensions of Deadlines for Submitting Drug Registration Applications' Supplemental Documents | ||
Date of the Deficiency Letter Issuance by NMPA | Whether the Current Date Is Before the Previous Deadline | Extended Deadline |
Before Oct. 14, 2022 | No | 80 workdays after Oct. 14, 2022 |
Before Oct. 14, 2022 | Yes | 80 workdays after the previous deadline |
Between Oct. 14, 2022 and Dec. 31, 2022 | / | 160 workdays after the deficiency letter issuance date |
*Drug registration application in China includes:
Investigational new drug (IND) application / clinical trial application (CTA)
New drug application (NDA)
Abbreviated new drug application (ANDA)
Re-registration application (for license renewal)
Supplemental application.
If you have any questions on drug registration in China, please contact BaiPharm for professional answers and regulatory compliance solutions.
