The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic priorities:
1. To accelerate technical reviews and regulatory approvals for innovative drugs
- SFDA will reward drug R&D which delivers better therapeutic effects on critical diseases and leads to indigenous intellectual property by accelerated technical reviews and regulatory approvals for the resulting innovative drugs.
- Innovative drugs whose R&D is sponsored by Chinese government will be given high priority in technical reviews.
- Pre-clinical studies of innovative drugs should be risk-based and their technical evaluation should aim for better control of quality risks. SFDA may outsource the task of technical review for pre-clinical studies to designated third parties.
- SFDA will explore the feasibility of performing technical reviews for innovative drugs along with the ethics review and consider allowing transfer of clinical trial authorizations.
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