Overseas Pharmaceutical Manufacturers to Face On-site Inspection
标签:on-site inspection, onsite inspetion, overseas pharmaceutical manufacturers, pharmaceuticals and medicines, pharmaceuticals and medines • 2012年8月28日 • 0 条评论
The opinion draft of on-site inspection for overseas pharmaceutical manufacturers is open for public comments. According to the draft Measures, if failing the inspection, the drug will be blocked outside China until it passes the next on-site inspection.
August 24, 2012
The State Food and Drug Administration (SFDA) solicits opinions on the Measures for the Inspection of the Overseas Pharmaceutical Manufacturers (draft), hereafter referred as the Measures. This draft will be open for public comments until 8 October 2012. According to the Measures, any pharmaceutical manufacturers fail the on-site inspection will face a severe penalty that the drug registration application will be suspended and the drug export to China will be ordered to stop.