Healthcare: Pharmaceutical medical device industry upgrade in the hope of recommending 3 shares

　　On August 18, the State Council issued an announcement on the Opinions on the Review and Approval System for medical devices Pharmaceuticals
and Medical Devices This is a comprehensive answer to the c.I.A formal response to the key issues of the recent drug medical device review and approval system reform in the industry This opinion formally determines the objectives and important time points of this reform: 1, strive to digest the backlog by the end of 2016, 2018 to achieve the prescribed time limit approval, 2018 to complete the consistency evaluation of oral preparations of basic drugs; We believe that companies with the ability to advance the development of high-quality generic drugs and have the ability to develop innovative drugs and innovative medical devices will ultimately benefit from this review and approval reform.　　Promote the evaluation of the consistency of generic drugs, promote the upgrading of the generic drug industry : new drugs, generic drugs and other basic concepts will change, the current three types of new drug concepts may disappear The reform opinion is intended to promote the consistency evaluation of domestic generic drugs, and the approved and future registration applications for generic drugs need to be evaluated in a consistent way The consistency evaluation will begin with the listed generics approved prior to 2007, with a focus on the evaluation of oral generic formulations in the base drug catalogue The main body of this consistency evaluation is the enterprise, CDFA will be in clinical application, bidding procurement, medical insurance reimbursement and other aspects of the enterprise through the conformity evaluation of generic drugs The competitive environment of generic drugs will realize the transformation of high quality and high price Domestic mature drug market generic drug preparationexport experience or high-quality generic production capacity of enterprises will be the first to benefit from this round of reform For example, Huahai Pharmaceuticals (600521, stock bar), Hesco (002653, stock bar) and Collum Pharmaceuticals (002422, stock bar
); The first is to carry out a pilot system of drug licensing holders, which can achieve the separation of research and development and production, encourage research and development institutions and researchers at important sources of innovative drugs to develop new drugs and obtain economic benefits, and reduce the burden of enterprise assets characterized by innovative drug development Second, the opinion encourages clinical value-oriented drug innovation, optimizes the innovative drug review and approval process, and achieves a balance between market value and clinical value Third, the opinion is intended to improve the approval of drug clinical trials and encourage domestic clinical trial institutions to participate in international multi-center clinical trials This is a good for domestic enterprises and foreign enterprises in the forefront of internationalization in mature markets Fourth, the opinion will reform the way medical device approval, encourage medical device research and development innovation The policy of domestic substitution trend of medical devices is favorable, and it is optimistic that enterprises with innovative capability of pharmaceutical devices and high-quality generic manufacturing capacity are optimistic: the summary of this opinion and the content of the previous review and approval of the class, the policy level focuses on improving the speed and quality of the review and approval, promoting the quality of generic drugs
upgrading , encouraging research and innovation Enterprises with high-quality generic manufacturing capacity, enterprises with high pharmaceutical innovation and development capabilities, and the CRO industry, which provides high-quality services to research and development enterprises, will benefit We recommend Huahai Pharmaceuticals, Tailong Pharmaceuticals (600222, Stock Bar) and Hengrui Pharmaceuticals (600276, sharebar) (Responsible Editor: HF056)