China to Raise Access Threshold for Pharmaceutical Excipients
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.
China published regulations on pharmaceutical excipients supervision to realize full supervision of the pharmaceutical production and supply chain since 1 February 2013.
China approved 301 additives and 107 resin items for food packing materials under the “clear-up” procedures. Besides of the details specified in each list, the general requirements in GB 9685-2008 should be complied with. As for the new additives for food packing materials that have not been officially approved in the GB 9685-2008 or other MOH announcements, the Provisions on the Management of Administrative Approval for New Varieties of Food Related Products shall be met accordingly.US FDA Issues Alert on Reumofan Plus, a Health Food
US orders to recall a dietary supplement due to harmful API components that can cause NSAID toxicity and discontinuation of corticosteroidMOH Releases National Food Safety Standards Projects in 2012
China MOH has released 82 national food safety standards projects in 2012. Responsible units in charge of the certain project should achieve the task before deadline. The enactment or revise of national food safety standards will further promote food safety in China.MOH Released 71 National Food Safety Standards
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