SFDA publishes high-risk excipients list
pharmafile | February 5, 2013 | News story | Manufacturing and Production |Â Â China, GMP, SFDAÂ
China’s State Food and Drug Administration (SFDA) has published a list of 28 excipients which are considered high-risk and therefore will need a manufacturing license before they can be used in pharma products.
The SFDA published a new regulation on the production and use of pharmaceutical excipients last August as part of its updated Good Manufacturing Practice (GMP) legislation, and this introduced two routes for them to be approved for use.
For existing, low-risk excipients the regulation requires registration via a drug master file (DMF) system, while novel or high-risk excipients while have to be approved based on a registration dossier.
The preliminary list of high-risk excipients – and the definition of high-risk – has now been published on the SFDA website (in Chinese) and is open for comment until 15 February.
In broad terms the list covers excipients used in sterile injectable formulations, those derived from natural sources and those with specific toxicological concerns.
Included in the list (in a number of cases when specified for injection) are glycerin, propylene glycol, tea oil, various grades of polyethylene glycol, polysorbate 80, lecithin, gelatin capsules and hydroxypropyl-beta-cyclodextrin, amongst others.
According to China’s GMP rules, the new requirements for excipients were due to come into effect last Friday (1 February), so the implementation deadline has clearly slipped.
Moreover, given that the SFDA has not yet drawn up finalised rules for the registration process for novel excipients – and indeed the DMF process for low-risk counterparts – there could be several months’ delay before they come into force. The DMF process is due to be agreed in the first half of this year.
When implemented, excipient GMP will become mandatory in China, although at the present time the level of GMP that will be required has also not been established.
Phil Taylor
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