On August 20, 2012, the State Food and Drug Administration (“SFDA”) issued a draft version of the Measures for Administration of Inspection of Overseas Drug Manufacturing Enterprises (Trial). The public is allowed to submit comments on the draft until October 8, 2012. The draft measures apply to all overseas drug manufacturers that have obtained or are applying for a Registration Certificate for Imported Drugs or a Registration Certificate for Pharmaceutical Products issued by the SFDA. The SFDA will, according to the information obtained through registration review, day-to-day supervision, port inspection and public reporting, determine a list of overseas drug manufacturers and categories on which it needs to carry out an on-the-spot inspection. The inspection team will usually comprise of 2 to 5 members and they will examine the authenticity of application materials and the GMP (“Good Manufacturing Practice”) compliance of drug manufacture process when conducting the inspection. Manufacturers who fail the inspection will be ordered to suspend their drug imports to China and their drugs that have already been imported to China may also be ordered to be recalled. Overseas manufacturers who refuse to accept the inspection without a cause or do not coordinate for the inspection will be deemed to have failed the inspection.
The full Chinese text of the draft measures is available here.