作者：Zeng-jun; Alex; XU
摘要：Although China is becoming one of the largest world market for drug sale and usage,new drug development has been behind the developed countries during the past decades.Many newly developed drugs approved in other countries cannot be easily accessed by patients in China.In addition,there were very few new drugs were approved domestically.To better protect the public health,Chinese government vowed to provide a better environment to encourage new drug development.These include a plan to reform the drug regulation system.As part of the reform,the Center of Drug evaluation(CDE)made great efforts to reform and improve the drug review systems so that new drugs may be go to the market quickly after thorough investigation.The goal of this reform is to establish a drug review system that may be in line with the international standards which are represented by the U.S.FDA,European EMA,and Japanese PDMA.During the past 2 years,great steps were taken on adoption and implantation of guidance released by international organizations,establishment of review teams based on clinical indications,application of advanced review concepts and theories,improvement of established communication system with the Sponsors,modifications on the priority review criteria,and shortening review time,etc.This presentation will focus on the impact of these reform measures on new drug development especially when the Sponsors plans to initiate their clinical studies.
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