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China struggles to speed up drug reviews

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China wants to prioritise new drugs and certain generics over more routine requests © Shutterstock

http://www.rsc.org/chemistryworld/2014/07/china-struggles-speed-drug-reviews

In an effort to accelerate slow regulatory drug reviews, the China Food and Drug Administration (CFDA) is attempting to outsource some reviewing processes and introducing fast-track priority reviews for selected generic drugs.

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Yin Li, deputy head of the CFDA, told the annual conference of medical information held in Beijing in May that the CFDA is planning to commission third-party organisations to share the overloaded reviewing responsibilities. In parallel, the agency is also revising regulations for drug registration, such that priority reviews can be given to generics with critical clinical value as well as brand new drugs.http://www.rsc.org/chemistryworld/2014/07/china-struggles-speed-drug-reviews

 

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