In August 18th,the State Council issued the opinions on the approval system for the review and approval of drug and medical devices.This is the official CFDA of the recent industry has been concerned about the medical device review and approval system reform key issues a comprehensive answer.
To speed up the review and approval system reform,the full range of registration applications to solve the problem:the National Drug Registration Center for drug registration application backlog.The views formally determine the objectives and important time of the reform of the class:1,the end of the year before the end of 2016 to digest the backlog of stock,in 2018 to achieve the approval by the prescribed time limit,2018 years ago to complete the work of oral preparation of basic drugs,2,improve the transparency of the review and approval;3,improve the quality of generic drugs,to encourage research and development of new drugs.We believe that the ability to promote high quality generic drug development,the strength of the development of innovative drugs,innovative medical device companies will eventually benefit from the review and approval of the reform.
Promote generic drug evaluation work,promote generic pharmaceutical industry upgrade:new drugs,generic drugs and other basic concepts will change,the current concept of the 3 types of new drugs may disappear.Reform proposals to promote the consistency of domestic generic drug evaluation work,has been approved and registered in the future of the application of generic drugs are required to carry out the same evaluation.Consistent evaluation of the work will be approved before 2007 listing of generic drugs,the focus will be on the basis of generic drugs in the list of generic drugs.The main body of the consistency evaluation is the enterprise,CDFA will be adopted in the clinical application,tender procurement,medical insurance reimbursement and other aspects of the company to provide support for the evaluation of the consistency of pharmaceutical companies.Generic competition environment will achieve the transition of high quality and low price.The domestic pharmaceutical companies have a mature pharmaceutical exports experience or high quality generic pharmaceutical production capacity of enterprises will be the first to benefit from the current round of reform.For example,Huahai sea Cisco and Kelun pharmaceutical;
Multi dimension to encourage innovation,and create a medical and healthcare industry innovation environment:the reform of the views put forward policies to promote industrial innovation.The first is to carry out the system of drug listing permit holders,the system can achieve research and development and production of separation,to encourage innovative drug research and development institutions and scientific research personnel to develop new drugs and to get economic benefits,reduce the burden on innovative drug development characteristics of enterprises.Second,opinions are encouraged to take the clinical value of drug innovation,optimize the approval process for innovative drug review,realize the balance between market value and clinical value.Third,opinions are intended to improve drug clinical trial approval,to encourage domestic clinical trial institutions to participate in international multi center clinical trial.It is a good news for domestic enterprises and foreign enterprises in the mature market.Fourth,opinions will reform the medical device approval,to encourage medical equipment research and development and innovation.Medical equipment domestic alternative trend of the trend is good policy,
Optimistic about the pharmaceutical and medical equipment innovation ability and high quality generic manufacturing capabilities of enterprises:the comments summary and refinement of the contents of the previous review and approval of the work,the policy level focus on improving the speed and quality of review and approval,and promote generic quality upgrade,encourage research and innovation.Has high quality generic pharmaceutical manufacturing capabilities,highly innovative pharmaceutical companies and enterprises and to provide high quality services for R&D enterprises will benefit from the CRO industry.We recommend Huahai,talph pharmaceutical and Hengrui medicine.
In August 2015,the State Council issued the opinions on the approval system for the review and approval of drug and medical devices.This is the official CFDA of the industry's concern over the recent reform of the key issues of drug review system,the general office of the State Council Information Office in August 18th invited the deputy director general of the CFDA administration of drug and medical device review approval system reform situation was introduced and answered reporters'questions.