Review and approval system for medical device review and approval:the State Council issued a document intended to resolve the core contradictions in the field of medicine,innovation and quality will become the core competitiveness of the investment tips:
Events:in August 18th,the State Council issued the"reform of the medical device review and approval system of the opinion".
The State Council issued a document intended to address the core contradictions in the field of medicine,innovation and quality will be the focus of policy support,domestic and foreign innovative medicine and clinical medicine will greatly shorten the review cycle,and the same effect will be more generic drug research and development only hard standards.
The opinions of the State Council issued on Reform of drug and medical device review approval system is a programmatic document for the reform of the field of medicine,some of the reform measures need to modify the current drug registration management,etc.,is expected to follow a number of heavy rules will be introduced.
Drug evaluation policy frequent,implementation details need to be further clear.The publication of the"opinions"clear all kinds of drugs and equipment review and approval principles,objectives and time nodes:1,to fight for the end of 2016 to resolve the backlog,in 2018 to achieve the standardization of the evaluation;2,2018 years before the completion of the consistency of the basic drug oral preparation;3,the pilot drug listing approval system;4.Details of the clear on the one hand shows the attitude of regulators,accelerate the policy of landing,on the other hand,the gradual advance of the measures and the time of the clear time to improve the market acceptance of policy.
By the end of 2016 to solve the backlog,the innovative drug benefit.The comments made a number of feasible measures to solve the existing backlog of more than 2 review,in the entrance:improve the registration fee standards,improve generic drug reporting threshold;increase the verification of clinical data;in the export side:to speed up the innovative drugs,clinical needs,in line with European and American Certification and other varieties,packaging and accessories and drug review,enrollment expansion,commissioned third party agencies to participate in technical review.These six measures to form a complementary with the previous self-examination policy,the CFDA must be resolved within 3 years to solve the problem of drug backlog,is expected to launch a follow-up policy is not reduced,good with research and development strength of innovative drug leading enterprises.
Comprehensive evaluation of the consistency of the agenda,the quality will continue to declare.Policy again focused on the evaluation of generic drugs and the consistency of the original research,based on the focus of the drug,the new declaration of the strict implementation of the principle of consistency.On the one hand to avoid the new low quality drugs,on the other hand,the impact of policies on the stock of the stock.Supervision of clinical reality enhancement,a declaration of the general problem given only a supplementary material opportunity,of false institutions directly cancel test qualifications.Evaluate the consistency and fraud punishment high standards are unprecedented,help to gradually resolve the general problems of low quality duplication of reporting and vicious competition.
The system and the efficiency of the system and the review of the system and the review of the system of the listed license holders of the pilot drugs.The listing system allows the development and production of new drugs,which is conducive to the development and production of the separation,the innovation of the existing system,the transfer of technology to the enterprise without duplication of technical review process,and improve the transparency of the review and guide the direction of new drug research and development,improve the operational efficiency of the review system.
Industry standardization continues to improve,innovation and quality will become the core competitive advantage.The comments continue in the direction of the policy,imitation product review more stringent,focus on improving the evaluation system and operational efficiency,a slight change in innovative product support:new medical devices and orphan drug policy,with a core patent or major clinical value of the device can be given priority review,cancer,rare diseases,medicine and other fields are also preferred review,and encourage international multi center clinical drug application.