The National Medical Products Administration (NMPA) has released a draft proposal titled “Announcement of the National Medical Products Administration on Further Optimizing the Review and Approval of Clinically Urgently Needed Overseas Marketed Drugs,” and is soliciting public feedback until July 24.
The draft proposal indicates that clinically urgently needed overseas marketed drugs, including originator drugs, chemical generics, and biosimilars, may be eligible for priority review and approval. These drugs may also be exempt from clinical trials following consultation with the NMPA, potentially leading to direct marketing approvals. For drugs that require clinical trials, a clinical trial approval decision will be made within 30 days of acceptance. The Center for Drug Evaluation (CDE) will manage market filings for clinically urgent overseas marketed drugs with priority review status, providing full-process communication and guidance.
Applicants for rare disease drugs that are urgently needed in clinical practice and are already listed overseas but not in China are encouraged to apply for registration testing through a pre-testing process. The registration testing timeline is reduced from 60 days to 40 days for those conducting sample testing. For those conducting standard review and sample inspection simultaneously, the registration inspection timeline is reduced from 90 days to 70 days. The required sample quantity for registration inspection is set at one batch of commercial scale production, with each batch containing twice the quantity required for quality standard inspection items.
The CDE has released three batches of product lists, totaling 73 varieties. Of these, 48 are now approved and listed in China, with an average review time of one year.- Flcube.com
