China’s SFDA to fast-track high-priority generics

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China’s SFDA to fast-track high-priority generics

Home/Guidelines | Posted 01/02/2013 0 Post your comment

China’s State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation and allowing the fast-track review of generic drugs which answer an unmet clinical need.

Innovative drugs that involve Chinese intellectual property and/or government-directed research and development will be encouraged through fast-track reviews and regulatory approvals. Pricing and reimbursement incentives will also be offered for companies developing paediatric drugs.

The decision comes as a result of the overwhelming number of applications the SFDA’s Center for Drug Evaluation (CDE) is currently trying to deal with, mainly due to repeat applications for generics already available on the Chinese market. A report by the CDE showed that 58% of the 3,950 abbreviated new drug applications received by the agency during 2012 involved products for which more than 20 generics had already been approved.

These measures, along with other measures that have been proposed to discourage applications for drugs of low clinical value or lacking in innovation, are intended to reduce CDE’s workload and reduce the time it takes for a drug to be registered in China. Currently, generics take on average four years for registration in China compared to only 2.5 years in the US.

SFDA has also committed to match international Drug Regulation Rules and is considering whether to allow data from clinical trials conducted overseas to be included in approval applications. Other proposals to reduce the CDE’s workload include increasing the involvement of China’s provincial authorities in the drug approval process.

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Source: IHS, SFDA