Current Staffing Levels at China’s SFDA May Hinder QbD Submissions; Investigational-Stage Changes and Timelines Also at Issue

International pharma is expressing concern that the ability to put ICH Q8-10 principles into practice in China is hampered by significant limitations in its current review manpower.

As a result of the lack of resources and experience with QbD filings, there is no assurance from China’s State Food and Drug Administration (SFDA) that a QbD submission to its Center for Drug Evaluation (CDE) would not extend already lengthy review and approval timelines.

Also problematic for international pharma are SFDA filing policies that do not accommodate manufacturing and formulation improvements while clinical trial and marketing applications are being reviewed.

The concern about the ability of the current SFDA processes to accommodate QbD-based filings and application-phase changes was in the spotlight 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.

At both meetings, Pfizer Global CMC Executive Director Chi-Wan Chen and Shanghai FDA (ShFDA) Chief Inspector and GMP Department Head Hua Zhang provided their insights on the rapidly-changing Chinese regulatory landscape.

Before joining Pfizer in 2008, Chen was the deputy director of FDA’s Office of New Drug Quality Assessment and now chairs the ISPE Asia Pacific Focus Group and serves as an ad hoc CMC advisor to RDPAC.  Zhang was a primary author of China’s 2010 GMP rewrite.

Chen focused primarily on CMC issues, providing an overview of China’s evolving drug registration system.  Along with the hurdles to the acceptance of QbD in China, she covered: ● issues with an API/pharmaceutical auxiliary materials draft regulation (IPQ “In the News” November 12, 2011), and ● China’s efforts to modernize and harmonize its filing regulations and the role industry and associations can play (IPQ “In the News” November 13, 2011).  Her presentation at the AAPS and ISPE sessions was co-authored by her Pfizer Global CMC colleague Charles Tong, who chairs the RDPAC CMC Focus Group.

Zhang, in turn, covered GMP developments, including China’s new overseas inspection initiative and the implications of the GMP rewrite, which was approved earlier this year (IPQ “In the News” November 10, 2011).

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