The filing requirements China is proposing for active pharmaceutical ingredients (APIs) and pharmaceutical “auxiliary materials” – including their mandatory nature and the lack of clarity regarding how changes to the filings will be handled – are areas of concern in international pharma’s assessment of the country’s evolving CMC program.
A draft regulation on “Filing of APIs and Pharmaceutical Auxiliary Materials” was released for public comment by China’s State Food and Drug Administration (SFDA) in the fall of 2010. A second public consultation on the new reg is expected to begin soon as a result of the extensive comments submitted on the draft, including those by the R&D-based Pharmaceutical Association Committee (RDPAC), which represents international companies in China.
The concerns on the draft regulation received attention at sessions focused on the evolving CMC and GMP efforts in China at the AAPS annual meeting in Washington, DC, in late October, and at the ISPE annual meeting in Dallas, Texas, in early November.
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