The innovative medicine industry has a new goal: to achieve more than 10 industrialized varieties in three years

[China Pharmaceutical network industry trends 】The three-year action plan is the five major development aspects of medical equipment, including imaging equipment, treatment equipment, in vitro diagnostic products, implant intervention products and specialized technical service platform It encourages PET-MRI, ultrasound endoscopy, laparoscopic surgery robot, neurosurgery robot and the whole laboratory automated testing and analysis pipeline (TLA) On December 26, the national development and Reform Commission issued the notice on the implementation plan of key technology industrialization in key areas of the three-year action plan for enhancing the core competitiveness of manufacturing industry (2018-2020), and formulated the implementation plan of key technology industrialization of medical devices and drugs Innovation driven, market-oriented, quality first and key breakthrough are the basic principles of the three-year action plan To achieve industrialization by breaking through a number of major key technologies, to form a group of leading enterprises with international influence, to create a number of well-known brands made in China, to create a number of internationally recognized Chinese standards, and to significantly improve the innovation ability and product quality of the manufacturing industry The overall goal of the action plan is to improve the overall quality During the 12th Five Year Plan period for the industrialization of innovative drugs, major special projects for new drug creation and development in China supported the development of 30 new drugs and completed the transformation and technological innovation of 200 large drug varieties With the continuous promotion of drug examination reform, the process of innovative drugs is also accelerating, and innovative drugs and imitation become the key content of the next stage According to the requirements of the plan, in terms of the industrialization of key technologies of new drugs, more than 10 innovative drugs should be industrialized within three years; through the listing of domestic first generic drugs or biological similar drugs, the drug consumption expenditure should be reduced by more than 5 billion yuan / year; the sales volume of preparations in European and American markets should reach more than 1 billion US dollars, and the new drug registration should achieve zero breakthrough In the treatment of major diseases such as tumor, cardio cerebrovascular disease, diabetes, immune system, virus and drug-resistant bacteria infection, we will promote the development and industrialization of targeted, highly selective and innovative drugs with new mechanism of action Promote the industrialization of chemical drugs of category 1-2 (new compounds and improved drugs), traditional Chinese medicine of category 1-6 (including ethnic medicine) and new classic famous formula products that have obtained new drug certificates or applied for new drug production since 2015, and the first bio medicine on the market in China In terms of major generic drugs, we should encourage the development and industrialization of the first chemical generic drugs and biological similar drugs with great market potential and high clinical value, promote the industrial upgrading of products through the consistency evaluation of generic drug quality and efficacy, improve the level of intelligent and green manufacturing in the production process, improve production efficiency and product quality, and reduce medical expenses As of December 6, 45 acceptance numbers had applied to CFDA for conformity assessment through bioequivalence test, 10 applications had been transferred from local drug administration to General Administration, 15 applications had been transferred from overseas listing to domestic listing, and 9 applications for withdrawing generic drugs had been reported again according to conformity assessment standard Not long ago, chinda Tianqing's tenofovir dipivoxil was approved as a chronic hepatitis B indication, and became a preparation variety that passed the consistency evaluation in China Two first imitations of colun were also approved during this period At the end of November, the on-site inspection of the first batch of generic drug conformity evaluation varieties has also started Some securities institutions predict that 87 products in the batch will be certified for conformity assessment of generic drugs It can be seen that under the support of policy change, generic drugs have gradually entered the realization period In addition, for internationalization, it is planned to build an international standard production base for new drugs and major generic drugs according to the requirements of drug registration and production in European and American markets We should develop one belt, one road market and encourage vaccine enterprises to build international production bases according to the requirements of WHO quality certification Accelerating the import of alternative medical devices and drugs is one of the nine key areas For medical devices, through the implementation of the plan, more than 10 innovative medical devices should be realized; more than 10 domestic medical device brands should be upgraded, the quality and performance should be significantly improved, and the sales volume should enter the top three market shares of similar products; leading medical device enterprises should be cultivated, and more than 10 medical device enterprises with sales revenue of more than 2 billion should be established Focusing on the construction requirements of healthy China and the development direction of medical device technology, we will focus on medical devices with large usage, wide application and high technology content, encourage the industrialization of innovative products mastering core technology, promote the transformation of scientific and technological achievements, promote the upgrading and upgrading of a number of key medical devices and the improvement of quality and performance, improve the stability and reliability of products, and give full play to the leading role of large enterprises Dynamic role, cultivate domestic well-known brands In the field of medical equipment, the pace of import substitution has not stopped From the national policy level, including healthy China 2030 and made in China 2025, they have put forward key requirements for medical equipment localization The three-year action plan is the five major development aspects of medical equipment, including imaging equipment, treatment equipment, in vitro diagnostic products, implant intervention products and specialized technical service platform It encourages PET-MRI, ultrasound endoscopy, laparoscopic surgery robot, neurosurgery robot and the whole laboratory automated testing and analysis pipeline (TLA) In fact, with the help of domestic policies in recent years, the support for local medical equipment enterprises has been increasing, which is gradually becoming a new favorite of investors According to incomplete statistics of e drug managers, from October 1, 2016 to September 30, 2017, the number of disclosed medical device financing cases was 136, with a cumulative amount of 10.77 billion yuan In terms of quantity, it is second only to biotechnology and medical services And the cumulative financing amount follows biotechnology, ranking the second in all pharmaceutical sub industries Insiders told E drug managers that the domestic medical device enterprises were relatively scarce, and the entire primary market had already seen a relatively large bubble Some investment institutions are less involved in the field of medical and health industry, and they believe that medical equipment will be easier to understand than more complex new drug projects Original title: National Development and Reform Commission: reduce drug consumption expenditure by more than 5 billion yuan every year! Realize industrialization of more than 10 innovative drugs in three years! Author: Xixi