Study On Improvement Of Drug Administration System After Reform Of Drug Registration

The newly revised "Drug Administration Law" which based on Reform of Drug Registration experience has formally established the system of Marketing Authorization Holder.But after my research,I found that "Drug Administration Law" is not perfect and there are still omissions in various issues during the pilot process.At the same time,other regulatory for drug administration have not been updated until now and cannot match the Marketing Authorization Holder system.The quality of Drug Administration affects the controllability,safety and effectiveness of drug and the health and the safety of people so that there must be no slackness.What problems have Marketing Authorization Holder brought and how to solve them is the focus of this article.This article observes the problems of drug administration and the shortcomings of the Drug Administration Law again,points out the missing problems,analyze the reasons and the solutions.In the end,we find out a practical way to solve problems under the experience from the U.S.,Japan and Europe which has developed mature pharmaceutical industry and experienceThe article is divided into five chaptersThe first chapter mainly describes the changes of drug registration system in China,introduces the "bundled" double license system and Marketing Authorization Holder system,analyze the significance of the reform of the Marketing Authorization Holder.The second chapter points out three problems according to different link of administration.This part starts from the drug's entire life cycle,and elaborates the problems in the registration,production,and responsibility of the drug supervisionThe third chapter analyzes the causes and finds that it's the insufficient drug laws and regulations and inadequate communication cause these problems.And then we sum up the concept and solutions according to the focus of administrationThe forth chapter puts forward suggestions that we should improve the drug regulatory system and establish risk communication.The drug regulatory system and drug regulatory experience in the US,EU,and Japan are very mature.Based on the reference and comparative analysis of drug regulatory experience in these developed countries,this chapter finds concrete countermeasures.