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CFDA Proposes Sweeping Action On Approvals, Poor Quality Submissions

This article was originally published in The Pink Sheet Daily

Executive Summary

From enforcing bioequivalence testing to punishing clinical data forgery, from requiring self-audits to forbidding simple formulation changes, the China FDA is proposing to strike hard against poor quality approval filings and meanwhile accelerate reviews for pediatric drugs and products submitted simultaneously with the US and EU.

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