lunes, 4 de febrero de 2013

China: Registro "fast-track para genéricos...


China's State Food and Drug Administration (SFDA) has announced proposals to fast-track the review of generic drugs for which there is high unmet clinical need, of innovative new products which involve Chinese intellectual property (IP) and of paediatric drug treatments. 

 The SFDA has now closed a public consultation on these proposals to reform the country's drug registration process. Its plans for reviewing generics include a fast-track process for high-priority drugs, measures to discourage applications for products which are of low clinical value and an emphasis on bioequivalence testing. These developments follow a report by the SFDA's Center for Drug Evaluation (CDE) at the end of last year which showed that nearly 60% of the 3,950 abbreviated new drug applications received by the Center during 2012 had involved products for which more than 20 generic versions had already been approved. (Más)
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