Medical network - on July 20, on July 19, the central deep reorganization, 37 times meeting examined and approved the "about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation" (hereinafter referred to as "opinions").
In August 2015, the state council issued the opinions on the reform of the examination and approval system for pharmaceutical medical devices, which marked the full launch of the reform of the examination and approval system for pharmaceutical medical devices.
Implementation of the reform for more than a year, the industry of many medical equipment companies are also the first to taste the reform "sweet", such as a another innovative medical devices approved quickly, one a rapid rise of domestic innovative machinery enterprise.
But what is undeniable is that, in the previous reforms in many matter YiXie enterprise interests and YiXie industry development important problem remains unresolved, or advance, such as overseas clinical trial data of domestic recognition, corporate r&d cost is it needed to drop, not all solve the backlog of contradictory registration and so on.
And creation of new "opinion", indicated the reform of medical apparatus and instruments for examination and approval of examination and approval on succeeding on a big step forward, more speed YiXie product approval listing, reduced cost of machinery enterprise research and development, the important measures to promote the competitiveness of the domestic, will be out soon.
This will undoubtedly be good news for domestic medical device enterprises in the stage of transformation and rising.
In addition, compared with the documents issued by the state council in 2015, the new "opinion" file name, is in addition to reflect the existing reform deepening, also highlights the connotation of the "encourage medical equipment innovation".
In connection with that, the CFDA issued four policy papers that encouraged innovation in medical devices, and solicited public opinion, two months ago.
These four files, respectively is: "about encourage pharmaceutical medical equipment innovation policies of protection of innovators (draft)", "about to encourage pharmaceutical medical equipment innovation drugs in whole life cycle of medical equipment management policy (draft)", "about encouraging drug medical devices of clinical trial management innovation reform policy (draft)", "about encouraging drug innovation of medical equipment To speed up the new medical equipment listed for examination and approval of the review of relevant policy (draft).
Four files put forward many New Deal, such as: a rare disease with medical device clinical trials can derate, class ii medical devices will gradually realize the national unification the review, the clinical test units from licensing system to the records, simplify the review process, clinical trials to accept overseas clinical trial data, implement the system of medical apparatus and instruments listed licensor, etc.
These are for advice "encourage medical equipment innovation" of the New Deal, and the new "opinion" should be in line, we also look forward to, the new "combination" of type, can speed up the reform of power innovation of medical equipment research and development and approval of the examination and approval, the benefit of more machinery.
Attachment: the full text of xinhua news agency on July 19
CPC central committee general secretary and state President and central military commission, chairman of the central comprehensively deepen reform leading group leader xi jinping hosted on July 19 afternoon central comprehensively deepen reform leading group 37 times the meeting and delivered an important speech. He stressed that various areas we need to put the thought and action unity to the reform of the CPC central committee decision deployment, starting from the service of the party and the nation's overall work to promote the reform, to take on responsibilities, good for work, seeking truth from facts, forge ahead, to advance the reform into effect, see practical results.
Li keqiang, liu yunshan and zhang gaoli, vice-leaders of the standing committee of the political bureau of the CPC central committee and the central committee of the CPC central committee, attended the meeting.
Meeting examined and approved the "about innovation system and mechanism for promoting the development of the agricultural green opinion", "national technology transfer system construction plan", "on deepening the implementation of the public cultural institutions legal person governance structure reform plan", "about to strengthen and improve the work of the Chinese and foreign cultural exchanges several opinions and appointment system of the civil service regulations (try out)", "about perfecting the import and export commodity quality safety risk early warning and rapid response the opinions of the regulatory system to protect consumers' rights and interests", "about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation", "set up the system of national park overall plan", "about improve the unified judicial appraisal management system of the implementation opinions of it. The meeting considered the progress report on the reform of the pilot work of the third plenary session of the 18th CPC central committee, and the report on the supervision of the social security system reform.
The conference pointed out that promoting the green development of agriculture is a profound revolution in the development of agricultural development, and is also the main target of the agricultural supply-side structural reform. To correctly handle the green agriculture development and ecological environment protection, food security, farmers' income, the relationship between innovation is beneficial to increase the green high quality supply of agricultural products, reduce the intensity of resource environment use, promote the institutions and mechanisms to increase rural employment and rural incomes, the formation of match with environment and resources carrying capacity, production and living in harmony ecological agricultural development pattern, realize the agricultural sustainable development.
The meeting stressed that to establish and improve the national technology transfer system and to focus will battle field affect the long-term development strategy, follow the rules of technology transfer, give play to the role of market mechanism, strengthening technical docking of supply and demand, through the transformation of science and technology channel, strengthen the linkage synergy, accelerate the transformation and application of major scientific and technological achievements, better play to the technology transfer to promote scientific and technological innovation ability and promote the important role of economic and social development.
Conference pointed out that promote the reform of public cultural institutions legal person governance structure, insist on the direction of socialist advanced culture, according to the requirements of the separating, tube being separated, in public libraries, museums, cultural centers, science and technology museum, art gallery, promote the establishment of public cultural institutions, such as the board of directors as the main form of legal person governance structure, absorb the relevant parties on behalf of, professionals and people from all walks of life to participate in the management, improve the management level of public cultural institutions and service efficiency, enhance the vitality of the public cultural institutions.
The meeting stressed that work to strengthen and improve the Chinese and foreign cultural exchanges, to establish the socialist road with Chinese characteristics confidence, confidence, system theory, the culture, from the overall situation of national reform and development and foreign strategy service, perfect the layout of the Chinese and foreign cultural exchanges, innovating the mechanism of high-level people-to-people and cultural exchanges, reforming the content of the humanities exchanges, form and working mechanism, the concept of cultural exchanges in all areas of the external exchanges, reveal the Chinese characteristic, Chinese style, Chinese style, promote mutual learning Chinese and foreign people are interlinked and civilization.
The meeting pointed out that the appointment system for some highly specialized posts is an important institutional arrangement for improving the selection and staffing system and strengthening the construction of the civil service. To uphold the party cadres, the party tube talented person principle, insist on having both ability and political integrity, good for first, insist on fairness, equality, competition and merit, adhere to the supervision and restriction and incentive pay equal attention to, in accordance with the statutory authority, conditions, standards, procedures, improve the level of specialization of civil servants.
The meeting stressed that to perfect the import and export commodity quality safety risk early warning and rapid response regulatory system, to put the interests of the people first, correctly handle the relationship between the quality safety and development, adhere to safety first, adherence to the bottom line, prevention first and combining prevention and control of, leading innovation, open sharing, comprehensively strengthen quality and safety risk monitoring, evaluation and early warning, management and disposal results using, to protect consumers' rights and interests.
The conference pointed out that the quality of medical devices and the development of innovation is an important guarantee for building a healthy China. To reform and perfect the evaluation system of examination and approval, the vitality of the medicine industry innovation development, the reform of clinical trial management, speed up the review of examination and approval, promote the quality of generic drugs and curative effect evaluation consistency, improve the food and drug regulatory system, to promote enterprise to improve innovation and research and development ability, to speed up the new good medicine market, meet the clinical need.
The meeting stressed that set up the system of national parks, on the basis of summarize experience, to insist on ecological protection first, national representative, national nonprofit national park concept, insist on ShanShuiLinTian HuCao is a community of life, to function restructuring related to nature reserve, straighten out the management system, operation mechanism innovation, improve the legal protection, strengthen the supervision and management, build represented by the national park system of natural protected area.
The conference pointed out that the judicial appraisal system is the judicial safeguard system which solves the specialized problem involved in the lawsuit and helps the judicial authorities to find out the facts of the case. Improve the unified judicial appraisal management system, to adapt to the trial centered lawsuit system reform, improve the work mechanism, strict professional responsibility, to strengthen the supervision and management, strengthen the cohesion of judicial appraisal and the handling work, continuously improve the quality of judicial authentication and credibility, safeguarding the smooth progress of the lawsuit activity to promote judicial justice.
The meeting stressed that since the third plenary session of the 18th, the CPC central committee to deploy has conducted a series of major reform, to explore a batch of replicable experiences which can be promoted, played a demonstration of the overall reform, breakthrough and leading role. Classification of the pilot should strengthen guidance and promote the pilot task has been completed as soon as possible in the surface, has made some progress to timely summary, slow progress, and the management of non-standard to supervise and urge the rectification implementation, comprehensive sex of strong attention should be paid to system integration, practice has proved effective to form related legal results in time.
The meeting pointed out that the reform and lead department is an important work in the implementation of the reforms already introduced. Since the eighteenth congress, relevant parties shall, in accordance with the deployment of the central committee, to create a more fair and more sustainable social security system as the goal, promote the reform of pension, medical insurance system as a whole, the social security system reform, significant progress has been made. The next step is to do a better job of rectifying the problems found, expanding the system coverage and better safeguarding the rights and interests of the people.
The meeting stressed that local stresses the reform to enhance their position, no matter at what level to promote reform, to carry out the work, must adhere to under the overall planning, advance in trend, as in much. The local party committee mainly responsible for the comrades should be good local reform leaders. In order to be realistic, we need to be able to implement the plan with the antennae and downground gas. The measures should be practical and practical, and the implementation measures should be practical and effective. In the reform and promotion, we need to make strategic tactics, pay attention to the way of doing things, and achieve one thing in a mature way. In evaluating the effectiveness of reform, we should stick to the people's position. The key is to see how many things are done and how many practical problems are solved. To insist on efficiency, speed is efficiency, the enemy is efficiency, and reduce mistakes is efficiency. In the case of delayed work, we need to reverse the period of work, catch up, and make some difficult changes, and the main responsibility of the comrades is to push themselves, to track progress, and to ring the bell. We must continue to forge ahead, and carry forward the spirit of reform in the first place. We should dare to break down the resistance to reform, and work hard to reform the reform.
Conference pointed out that reform at all levels to complete with strength, increase the reform and innovation in the cadre assessment and promote people's weight, fault tolerant error correction mechanism, establish and improve the reform form allows the reforms have mistakes, but don't allow sharp direction.
The members of the central committee of the CPC central committee and the relevant departments of the state organs are responsible for the meeting of the comrades. |
