Life sciences partner Katherine Wang (Shanghai) was featured in articles published by Bloomberg BNA’s Life Sciences Law & Industry Report on May 19, Drug Industry Daily on May 16, and Pink Sheet on May 15 discussing China Food and Drug Administration (CFDA) issuing new policy and regulatory proposals on drug and medical device approvals and clinical trial processes. Drug Industry Daily cited a Ropes & Gray alert authored by Ms. Wang titled “China FDA Calls for Comments on Key Policy Proposals.”
In Pink Sheet and Bloomberg BNA, Ms. Wang explains CFDA 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 drug originator companies. The CFDA proposals are designed to encourage innovation, enhance post-market supervision throughout a product’s entire life cycle, and protect the rights of innovators.
She notes that the proposed CFDA measures are “historic and unprecedented.” For example, it is the first time that the CFDA has specifically outlined a 60-day waiting period for clinical trial authorizations and conditional approvals for urgently unmet medical needs and orphan drugs approved outside China.
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