On 23 Jan, the first batch of 28 excipients for which registration permit is required has been released for public consultation until 15 Feb 2013. Along with the list, the official definition of new excipient is clarified as the excipients and additives used the first time in the drugs which have been placed on the market. For the excipients having been used, if it is the first time to change its route of administration or to increase the application amount, the excipient will be handled as a new excipient as well.

The manufacturers of excipients under registration approval management are required to submit related documents. Provincial FDA will conduct on-site inspection and random tests in accordance with the Good Manufacturing Practice for Drug Excipients. After the final review by the SFDA, the excipient will be approved. The supporting documents for excipient approval and record-keeping are yet to be released. The imported excipients are also required to follow this regulation, that is, to apply to the SFDA for registration permit or recording-keeping.

Table1. First Batch of Excipients under Registration Management (Draft)

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