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China FDA Proposes Sweeping Reforms To Incentivize Innovation

 
• By Brian Yang

The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.

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China Proposes New Regulatory Overhaul • Source: Shutterstock

The China FDA has issued four major new policy and regulatory proposals that cover a wide range of topics related to review processes, clinical trials management, whole-process monitoring, and new incentives for innovation, including patent linkage and exclusivity periods to protect originator companies.

Many see the new policies, released May 11, as representing the most sweeping changes to date to be released by...

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