China to encourage innovative drug development

0 Comment(s)Print E-mail Xinhua, February 26, 2013
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China's drug safety watchdog on Tuesday issued a plan to reform the registration process for new drugs in order to encourage innovative research and development.

Wang Lifeng, director of the drug registration department of the State Food and Drug Administration (SFDA), 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The plan calls for impractical application requirements to be withdrawn for new drugs, as previous requirements called for the drugs' specifications and quality standards to be determined when applying for registration.

The new plan allows producers of new drugs to provide a draft version of their application when applying for registration, as well as calls for drug specifications to be clarified during the period between registration and mass production.

The plan says some generic drugs will be given priority in the approval process, particularly drugs that are in short supply, lack a branded competitor or that are used to treat rare diseases.

The plan also calls for an ethics committee to independently evaluate clinical drug trials in order to protect the rights and interests of test subjects. Endi

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