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Entry into Force of New Regulations for Pharmaceutical Excipients – Old Wine in a New Bottle?

China Insight - Lifesciences


On 1 August 2012, as a result of the toxic capsule scandal, the State Food and Drug Administration (“SFDA”) issued Provisions on Strengthening the Supervision and Administration of Pharmaceutical Excipients (the “Provisions”). The aim of the Provisions is to streamline the chaotic administration of pharmaceutical excipients and impose tighter regulations on excipient manufacturers. The Provisions, which will come into effect on 1 February 2013, are considered to be the most stringent pharmaceutical excipients regulations thus far and are likely to cause considerable debate within the pharmaceutical industry.

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China Insight - Lifesciences
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Portrait of Nicolas Zhu
Nicolas Zhu