CFDA releases manufacturing guidance

In newly released draft guidance, China FDA said drug manufacturers will need to report to the agency any revisions to their approved manufacturing processes, then conduct studies showing that their new processes do not affect drug quality, according to Goldman Sachs analyst Richard Yeh. Those that cannot do so will face suspensions of production pending approval of their new processes, the analyst said.

Manufacturers of CFDA-approved drugs will have until Oct. 1 to conduct self-inspections before the agency begins unannounced inspections on Nov. 1, according to Yeh. After self-inspecting, those reporting revisions to their processes will have until June 30, 2017, to conduct studies showing that drug quality is unaffected by the changes. The deadline will be YE17 for manufacturers of drugs that are not in regular production. ...