Since the reform of medical reform，The pharmaceutical industry is turbulent，The so -called medicine does not separate，The tightness of the policy is also self -evident。2016 is the first year of the 13th Five -Year Plan & RDQUO;，I have introduced a lot of policies，And related medical treatment、Drug、The policy of medical equipment is heavyweight。Whether it is in the management of the enterprise，It is still given stricter standards in the quality inspection of the medicine，and also affect the development of the industry as a whole。

 

  1、"Opinions of the General Office of the State Council on the Evaluation of the Consistency of the Quality and Consistency of the Make Drugs"

 

 

  The consistency evaluation of quality and efficacy is to require imitation drugs that have been approved for listing，It is necessary to be consistent with the original research medicine in terms of quality and efficacy，Clinically with the original drugs can replace each other，Medical costs that are beneficial to society。On February 20th, the General Office of the State Council issued the "Opinions on Promoting the Evaluation of the Consistency of the Quality and Effect of Photics"。

 

  "Opinions" Requirements，New registration of chemical drugs is approved before the implementation of the publication of the publicity，Approves that it has not been approved in accordance with the principles of the quality and efficacy of the original drug，All consistency evaluations must be carried out。Emphasizing that drug production enterprises are the main body of consistency evaluation，It should be actively purchased by the participation preparation to carry out related research，Make sure the quality and efficacy of the drug are consistent with the reference preparations。Clarifying the node of time: completed the new drug registration method on October 1, 2007 before the end of 2018。At that time，No evaluation，Logged out the drug approval number。For other drugs that have been approved for market，Since the first variety passes the consistency evaluation，The same variety of other manufacturers has not passed the evaluation within 3 years，Logged out the drug approval number。

 

  2、"Opinions of the General Administration on Solving the Pharmaceutical stake betting appMy stake betting appRegistration Application of Revolutionary Examination and Approval"

 

  The State Food and Drug Administration issued the "Opinions of the General Administration on Solving the Perception of Pharmaceutical stake betting appMy stake betting appRegistration Application for Reconstruction Approval" on February 26，The purpose is to strengthen drug registration management，Speed ​​up new drugs with clinical value and research and development of new drugs and clinical urgent need for generic drugs，Conflict on the backlog of drug registration applications。

 

  "Opinions" pointed out that drug stake betting appMy stake betting appRegistration Applications and specific diseases with obvious clinical value (AIDS 、tuberculosis 、Viral hepatitis 、Rare disease 、malignant tumor 、Children's medicine 、Pharmaceutical registration applications that are unique and multiple diseases of the elderly) are given priority review and approval。For clinical urgent needs、Application of imitation drugs for market shortages，From the date of publicity of this variety，No longer accepting active ingredients and the same way of administering the way to give priority review and approval application。For the entire pharmaceutical industry，The opinion of this opinion means that the drug review environment is improved as a whole，It is expected to solve the backlog of drug registration applications to a certain extent，Failure to the healthy development of the pharmaceutical industry。

 

  3、"Notice of the State Council on the Development Strategic Planning of TCM Development (2016 & mdash; 2030)"

 

 

  "Outline" clarifies the key task of the development of Chinese medicine in the future: improves the traditional Chinese medicine medical service network covering urban and rural areas，Promote the combination of traditional Chinese and western medicine and the development of national medicine，Relaxing Chinese medicine service access，Promote & ldquo; Internet+& rdquo; Chinese medicine medical treatment; vigorously develop traditional Chinese medicine health care services，Accelerate the construction of the service system，Improve service capabilities，Promoting Chinese medicine and health care、The integration and development of the tourism industry; fully do a good job of inheritance of the theoretical method of traditional Chinese medicine，Strengthening traditional Chinese medicine knowledge protection and technical mining，Strengthen the education of Chinese medicine divisions; focus on promoting Chinese medicine innovation，Strengthening major difficult diseases、Joint research on major infectious diseases，New progress has been made to promote the creation of new Chinese medicine new drugs; comprehensively improve the development level of the Chinese medicine industry，Strengthen the protection and utilization of traditional Chinese medicine resources，Promote the standardized planting and breeding of Chinese medicinal materials，Promoting the transformation and upgrading of the Chinese medicine industry，Construct a modern Chinese medicinal material circulation system; actively promote the development of Chinese medicine overseas，Strengthening foreign exchanges and cooperation，Expand the international trade of Chinese medicine。

 

  4、"Guiding Opinions on Promoting the Healthy Development of the Medical Industry"

 

  "Opinions" clarified seven key tasks.

 

  1 is to strengthen technological innovation，Improve the core competitiveness。Improve the pharmaceutical collaborative innovation system for government -based and My stake betting appstake sports betting appresearch and research，Promoting major drug industrialization，Accelerate the transformation and upgrade of medical equipment，Promote the modernization of Chinese medicine。

 

  Second is to speed up quality upgrades，Promote green security development。Strict production quality management，Improve quality control technology，Improve quality standard system，Implementing green transformation and upgrading。

 

  Third is to optimize the industrial structure，Improve the level of intensive development。Adjust the industrial organization structure，Promoting corporate mergers and reorganization。Give full play to regional element resource advantages，Promote the coordinated development of the region。Guide industrial agglomeration development，Create a batch of industrial clusters。

 

  Fourth is the development of modern logistics，Build a medical integrity system。Establish a modern marketing model，Promoting the construction of drug circulation and distribution networks that spread to urban and rural areas。Strengthen the construction of the integrity system，Improve the management mechanism and system of medical integrity。

 

  Five is closely connecting the medical reform，Create a good market environment。Improve the medical service system，Promote doctors more practice，Improve service capabilities of primary medical institutions。Strengthen the price、Medical Insurance、Connection of policy and other policies for bidding and procurement，Strengthening medical expenses and price behavior comprehensive supervision。

 

  Six is ​​deepening foreign cooperation，Expand international development space。Accelerate the development of the international emerging pharmaceutical market，Optimized product export structure。Promoting the production line of enterprise construction in accordance with international quality specifications，Accelerate the internationalization process of testing and certification。Fighting the allocation of resources in the world，Accelerate the pace of international cooperation。

 

  Seven is cultivating emerging formats，Promoting industrial intelligent development。Intelligentization of promoting the production process of pharmaceutical production，Development of smart factories and digital workshops。Leading the leading role of high -quality medical resources，Carry out remote image diagnosis、Experts consultation、Surgical guidance and other remote medical services。

 

  5、"Deepening the Reform of the Medical and Health System 2016 Key Work Task"

 

  2015，Per capita expectations of 76.34 years，increased by 1.51 years older than 2010，People's health level generally reaches a medium -to -high -income country average，The proportion of residents' personal hygiene expenditure accounted for less than 30%，The lowest level in the past 20 years。Positive progress and results achieved by medical reform，It laid a solid foundation for the continuous deepening reform。2016 is the beginning of the start of the 13th Five -Year Plan & rdquo;，It is the year to achieve the phase goal of deepening the reform of the medical and health system by 2017，It is also the key year for everyone to enjoy stake betting appthe goal stake online sports bettingof basic medical and health services by 2020。

 

  "Deepening the Reform of the Medical and Health System 2016 Key Work Task" includes how to implement the reform of public hospitals，Accelerate the construction of the hierarchical diagnosis and treatment system，Consolidate and improve the national medical insurance system，Improve the drug supply guarantee mechanism，Establish a sound comprehensive supervision system and other content。Further promote medical treatment、Medical Insurance、Three Medical Medicine Link，Grasp the drug production、Purchasing、circulation、Delivery、Use key links and other key links to further improve the drug supply guarantee mechanism。Comprehensive medical reform pilot.，Circulating enterprises to issue an invoice to medical institutions)，Actively encourage the pilot cities of public hospitals to reform & ldquo; two votes & rdquo;。

 

  6. "Specifications for Quality Management of Clinical Tests of Medical Device"

 

  To strengthen the supervision and management of clinical trials of medical equipment，Maintenance of the subject's rights and interests during the clinical trial of medical device，Make sure the clinical trial process specifications of medical equipment，State Food and Drug Administration、The National Health and Family Planning Commission jointly released the "Quality Management Specifications for Clinical Test of Medical Device"。

 

  "Specification" emphasizes the following aspects:

 

  1 is to clearly clarify the clinical trial applicant、Clinical trial institutions and researchers, as well as the responsibilities of the regulatory authorities of clinical trials，Emphasizing the management responsibility of the organizer for clinical trials、Refine the responsibility and obligation requirements of clinical trial institutions and researchers。

 

  Second is to strengthen the protection of the subject's rights，Improve the relevant management system and requirements，The role of the ethics committee and the consent of the subject's knowledge，It is clearly requested that the applicant's expenses and corresponding economic compensation for the applicant to the treatment of the test related to the test or the death of the test。

 

  Third, strict clinical trial risk management，Emphasize risk control of the entire process of clinical trials，Clarify the suspension and termination mechanism of clinical trials，Implement the main responsibility of the applicant，Ensure that the clinical trial process is safe and controllable。

 

  7.

 

 

  Pilot administrative area (Beijing、Tianjin、Hebei、Shanghai、Jiangsu、Zhejiang、Fujian、Shandong、Guangdong、Sichuan, etc.) Pharmaceutical research and development institutions or researchers can be used as applicants for drug registered，Submit a drug clinical trial application、Drug Listing Application，The applicant obtains the drug listing license and the drug approval number，Can be a drug listing license holder。

 

  Current，The management model of implementing listing licenses and production licenses on domestic drugs，Only allowing drug manufacturers to obtain the drug approval number，After certification by the quality management of drug production，Fang can produce this medicine。In practice，Drug research and development institutions and researchers cannot obtain the drug approval stake sports betting appnumber，stake betting appNew drug research and development institutions can only transfer relevant drug technology to drug production enterprises after obtaining the new drug certificate。This drug registration and production license & ldquo; binding & rdquo; mode，Not conducive to encouraging innovation，Is not conducive to ensuring drug supply，Is not conducive to suppressing low -level duplicate construction。

 

  Pilot the system of listing permit holders，The most important difference between the current management system is，Allow R & D institutions and researchers to hold drug approval number，Becoming a Pharmaceutical License held by holder，and the safety of the drug、Effectiveness and quality controllability with comprehensive responsibility。Piloting the pilot work of the holder system of the pharmaceutical listing permit，For encouragement of drug innovation、It is important to improve the quality of drugs。

 

  Here，Everyone may be more concerned about & ldquo; two votes & rdquo;，But so far, there is no specific two -vote policy。Since the Executive Meeting of the State Council on April 6，The two votes proposed in the meeting are attracted much attention。Since 2016，The Medical Reform Office of the State Council also solicited some pharmaceutical companies、Industry Association、Industry experts and other opinions。Recently，It also held & ldquo; implemented drug circulation & lsquo; two votes & rsquo;，The National Development and Reform Commission attended the meeting、Business Department、Health and Family Planning Commission、Ministry of Finance、The State Taxation Administration、Ministry of Industry and Information Technology、Food and Drug Administration、Traditional Chinese Medicine Bureau、China Medical Enterprise Management Association and other departments，The convening of the symposium may indicate that the national landing policy documents that are related to & ldquo; two -vote & rdquo;。