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.
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标签：excipient, pharmaceutical excipients, pharmaceuticals and medines • 2012年8月10日 • 0 条评论
China published regulations on pharmaceutical excipients supervision to realize full supervision of the pharmaceutical production and supply chain since 1 February 2013.
On 2 August 2012, China’s State Food and Drug Administration (SFDA) issued the Regulation on Strengthening Pharmaceutical Excipients Supervision in a press conference (hereinafter referred to as the “Regulation”), which will come into effect since 1 February 2013. Under the Regulation, the respective duties and obligations of pharmaceutical manufacturers and excipient manufacturers are specified accordingly. The pharmaceutical manufacturers will take the primary responsibility for illegal use of excipients in producing drugs and should assure the quality of excipients purchased from their excipient suppliers. So pharmaceutical manufacturers are required to fortify the quality management system and sign quality agreement with the main suppliers in the Regulation. The pharmaceutical excipient manufacturers should strictly comply with the Good Manufacturing Practice (GMP) for Pharmaceutical Excipients in the process of production, while which being effective since 2006 is only taken as a voluntary standard before the issue of the Regulation.
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