Improve China's Generic Drug Registration Management System

China is a major genetic drug production country and genetic drugs gain good market prospect,but not a powerful one,because the genetic drug registration management is not in line with the international advanced management mode and the registration requirements has certain gaps to the international advanced level.At present,the goal of the genetic drug registration management is to improve the quality of generic drugs and ensure consistency of generic drugs and innovator ones in quality safety,and efficacy so as to shorten the gap between our genetic drug registration management system and the international advanced level.Based on this goal,this article adopts literature method and comparison method, begins with how to perfect the generic drug registration management system and makes a research on the genetic drug registration management system from the perspectives of the legislation system,the organization establishment,the registration and approval procedures, the documents of registration appliction,etc.Through comparison and analysis of genetic drug registration management system in china,U,S,A,,and Europe,it points out the main problems currently existing in Chinese drug registration management system:lack of the clear legal definition and upper law for the genetic drug,imperfect legislation system;the SFDA lacks independent evaluation institutions,expert evaluation system is not perfect;registration procedures are complex; registration documents has a gap to the international CTD format.To solve these problems,combining Chinese the generic drug registration management development level,referring to the successful experience of the USA and the EU,this article puts forward proposals on perfecting the genetic drug registration management:in the aspect of laws and regulations setup,our country should build scientific approval strategies which is suitable for china,make a certain definition of generic drugs and construct the matching laws and regulations system and perfect generic drug sustainable system;in the aspect of management departments setup,we should set up a special institute to approval genetic drugs,strengthen group building of approval personnel,build an approval force with the perfect technical power and reasonable professional structures;in the aspect of registration management procedures,our country should simplify the approval procedure of the generic drug registration,combine spot examination before permitting production with drugs GMP authentication together,shorten the span of approval time,fasten the speed of the genetic drugs listed market;in the requirements of application registration documents,we should achieve the unification of ours and international CTD format,strengthen the management of drugs instruction and package tags,introduce the idea of"QbR",develop the in Vivo-in Vitro Correlation study, research out the approval documents format suitable for china.The suggestions put forward involve full consideration of actual conditions in China and establish a certain foundation for the further study of generic drug registration management system.