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IPEC Americas backs new SFDA excipient regs; English translation available


IPEC Americas, SFDA, excipient, regualtions

The International Pharmaceutical Excipients Council (IPEC) Americas has welcomed new SFDA excipient quality and supervision regulations, which it says are largely consistent with its own guidelines.

The Chinese Food and Drug Administration (SFDA) published the new regulations earlier this monthEnglish version available here thanks to the translation efforts of IPEC China – setting out the responsibilities drugmakers, excipient suppliers and regulators have in ensuring excipient quality.

The new guidelines – which are due to come into effect on February 1 next year – are part of a wider overhaul of the SFDA’s excipient oversight that includes a revision of the excipients listed in the Chinese Pharmacopoeia.

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