Chinese FDA Unveils Plan for Regulatory Reform

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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.

Please see full alert below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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