Drugs that have already won approval and those that are still in development are both affected by the latest document. CFDA wants to make manufacturers of generics that have already come to market carry out the same conformity assessment it plans to put development-stage drugs through. Manufacturers who fail to perform the assessment by a certain deadline will lose their marketing approval. The requirement is intended to weed out drugs that fall short of the new standards.
CFDA is seeking feedback on this requirement and its draft advice on generic research processes, from the selection of the reference product through to tests for in vivo bioequivalence and in vitro dissolution. The regulator views actions to improve these processes as a way to make the Chinese generics industry more competitive globally, while also raising the quality of products that are sold locally.
Officials at CFDA plan to change their own activities to facilitate these improvements. The draft document includes sections on the need for CFDA to retool its operation to oversee the consistent evaluation of generic filings and a call for a government-wide shift in approach to the sector. Part of the goal is to strengthen coordination and cooperation between different government departments to promote the agenda of generic quality.
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