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

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.... Share this with colleagues: // //