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China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

Nov 13th, 2011

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The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing.

In the effort to modernize and harmonize its regulatory framework, SFDA has translated international regulations and guidelines into Chinese for its internal use, and has accelerated dialogue with industry associations with a presence in China, including the R&D-based Pharmaceutical Association Committee (RDPAC), the International Society of Pharmaceutical Engineering (ISPE) and the International Pharmaceutical Excipients Council (IPEC).

Formative sessions focusing on the evolving CMC and GMP efforts in China were held at the AAPS annual meeting in Washington, DC, in late October, and at the ISPE annual meeting in Dallas, Texas, in early November, where these opportunities were explored.

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 regulatory landscape in China.

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Also see the following recent related stories:

China’s SFDA Begins Inspections of Overseas Manufacturers

Current Review Policies and Staffing Levels at China’s SFDA at Odds with its ICH Q8-10 Objectives

Draft “DMF” Regulation in China Draws Industry Association Attention

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