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CFDA will Require Pharmas to Self-Report any Drug Manufacturing Changes

publication date: Aug 15, 2016
China's FDA has released a draft of new rules that require drugmakers to self-report any changes to drug manufacturing procedures, followed by studies that show the drug's efficacy is not harmed by the changes. The self-reporting is similar to CFDA rules issued last year asking drugmakers to self-report any errors in submitted clinical trial data. If the CFDA finds unreported changes in manufacturing procedures, it will consider the product a counterfeit drug, with corresponding penalties. More details....

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