The Chinese Food and Drug Administration (SFDA) published the new regulations earlier this month – English 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.