SFDA To Speed Up Evaluation Of Registered Drugs
This article was originally published in PharmAsia News
Executive Summary
To solve the problem of evaluating a huge backlog of registered drugs, China's State FDA has begun a centralized drug evaluation strategy since January to handle approved but overdue applications before the revised Drug Registration Regulation becomes effective. The new approach is divided into two stages: January to April 2008 was the data comparison stage where SFDA sieved out registration applications with similar information, content or fabricated data to ensure authenticity; April to September 2008 is the technical evaluation stage where experts meet to adopt centralized review techniques and methods in new drug development. (Click here for more - Chinese Language)
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