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China's SFDA Announces Major Reforms to Drug Regulatory Process

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By Louise Zornoza, RegLink

China’s State Food and Drug Administration (SFDA) has announced that it is implementing a series of reforms designed to improve the drug review and approval process, “and to promote the healthy development of China’s pharmaceutical industry.” 

Wang Lifeng, director of the SFDA’s drug registration department, said the plan provides incentives for the research and development of innovative clinical drugs, adding that the approval process will be shortened for these drugs.

The changes track four categories of reform, meant to address some of China's drug regulatory challenges from a number of different angles.

The first reform targets the creation of a favorable environment for the research and development of innovative new drugs through “independent” intellectual property rights and an expedited drug review process.  Impractical application requirements currently in place will be withdrawn, such as a requirement for determination of a new drug’s specifications and quality standards when applying for registration.

The second focuses on developing a revised national strategy for generic drugs.  The plans calls for the allocation of adequate review resources to generic drugs, with some getting priority in the approval process, and in particular those that are in short supply, lack a branded competitor or are used to treat rare diseases.

The third is to strengthen the quality and management of pharmaceutical clinical trials, and calls for evaluation of trials by an independent ethics committee in order to protect the rights and interests of test subjects.

The fourth and final reform announced by the agency is to encourage the development of medicines for children.




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