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CFDA Surprises Industry With Clinical Data Self-Audit Notice

This article was originally published in PharmAsia News

Executive Summary

Drug makers have 34 days to self-audit the clinical data submitted in their clinical trial or new drug filings, and to submit an authentication report bearing legal representatives’ signatures. Those failing to do so will face unannounced inspections and may have to voluntarily withdraw their regulatory filings, the China FDA has warned.

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