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China proposed Policies about Encouraging the Innovation of Drugs and Medical Devices and Reforming the Management of Clinical Trial

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China proposed Policies about Encouraging the Innovation of Drugs and Medical Devices and Reforming the Management of Clinical Trial

China Food and Drug Administration proposed policies aim to encourage the innovation of drugs and medical devices and accelerate the review and approval for the launching of new drugs and medical devices. The main content is as follows, accelerating the review and approval of drugs and medical devices which are urgent for clinical use; supporting the research and development of drugs and medical equipment for rare diseases treatment; stricting the review and approval of injection; adjusting the management model of the pharmaceutical raw materials, excipients and packaging materials; improving the review system of drugs and medical devices; supporting the clinical application of new drugs; as well as the inheritance and innovation of traditional Chinese medicine; establishing a preferential examination and approval system based on patent compulsory license etc.

Product cover: Drugs, Medical devices

HS code: 30, 9018

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: 25-11-2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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