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China’s SFDA Begins Inspections of Overseas Manufacturers

Nov 10th, 2011

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China’s State Food and Drug Administration (SFDA) is initiating inspections of pharmaceutical manufacturing facilities overseas that sell products in China as part of its ongoing effort to modernize and harmonize regulatory practices with international standards and ensure the quality and safety of medicines sold in its country.

The effort, beginning in November, will cover about ten companies in the US, EU, South Korea and India that manufacture vaccines, APIs, biologics, and oral solid dosage forms and have agreed to participate and help SFDA develop and hone its inspection procedures.

At the AAPS Annual Meeting in Washington, DC, in late October, Shanghai FDA (ShFDA) Chief Inspector and GMP Department Head Hua Zhang explained that SFDA has been developing the framework and resources for these inspections since 2008, and has trained “about 100” inspectors on how to perform them.  She stressed that SFDA is now ready to begin its foreign inspection effort.

In addition to the inspection update, Zhang provided an insider’s look at the history of GMPs in China and the specific provisions in the newest revision of its GMPs approved earlier this year, of which she was a primary author.

The ShFDA official covered: ● an introduction to GMPs in China ● the 1998 GMP framework ● promotion of GMPs in China ● the 2010 GMP revision and new requirements, and ● the implementation challenges for the Chinese regulators and the domestic and international industry manufacturing in China.

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the full story for $195 — or the series of four recent IPQ stories on China for $295 – by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

Also see recent related stories:

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

China’s CMC Harmonize Efforts Provide Opportunities for Industry Input

Draft “DMF” Regulation in China Draws Industry Association Attention

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