Review of China's biomedical industry policies in the third quarter of 2018

Since the third quarter of this year, a series of policies have been issued, such as the technical guidelines for accepting the data of overseas clinical trials of drugs, and the notice on Soliciting Opinions on the list of clinically urgent new drugs that have been listed overseas The policies of China's biomedical industry are further in line with the international standards The measures for the administration of Internet hospitals (for Trial Implementation), the notice on printing and distributing the national health and medical big data standards, safety and service management measures (for Trial Implementation) and other policies further strengthen the policy supply of China's biomedical industry The following is the key policies of China's biomedical industry in the third quarter of 2018 created and sorted out by flint: national policies On July 10, the State Drug Administration organized and formulated the technical guidelines for the acceptance of overseas clinical trial data of drugs, which made clear the application scope, basic principles, integrity requirements, technical requirements for data submission and acceptance degree of overseas clinical trial data In July 12th, the national health and Health Committee issued the notice on developing Internet plus medical health for the convenience of the people The notice made it clear that we should speed up the construction of smart hospital, use Internet information technology, transform and optimize the diagnosis and treatment process, link all links before, during and after diagnosis, and improve the medical experience of patients On July 24, the State Drug Administration drafted the announcement on matters related to the registration and related review and approval of APIs, pharmaceutical excipients and drug packaging materials used in pharmaceutical preparations (Draft for comments), which clarified the related review and approval of APIs, pharmaceutical excipients and drug packaging materials used in pharmaceutical preparations On July 28, the CSRC issued the decision on revision, which made it clear that if the listed companies constitute major illegal acts in the fields of national security, public security, production safety and public health and safety, the stock exchange shall strictly make the basic system requirements for the decision to suspend and terminate the listing of the company's shares in accordance with the law On August 1, the new "medical device classification catalog" began to be implemented The State Drug Administration will further strengthen the construction and management of the classification catalog system, establish the working mechanism and operation procedures, and timely analyze and scientifically evaluate the risk changes of medical devices On August 8, the center for drug evaluation (CDE) issued the notice on Soliciting Opinions on the list of clinically urgent new drugs that have been listed overseas, which combed the new drugs approved for listing in the United States, the European Union or Japan in recent years, and selected alectinib The list of 48 new drugs that have been listed in clinical need overseas, such as hydrochloride, can be submitted or supplemented with all the research data obtained overseas and supporting materials without ethnic differences, and directly apply for listing On August 16, the State Administration of traditional Chinese medicine and the Ministry of science and Technology issued the guiding opinions on strengthening the scientific and technological innovation of health service of traditional Chinese medicine, strengthening the guidance on the theoretical research, product research and development, service mode and mechanism innovation of health service of traditional Chinese medicine, proposing to establish the scientific and technological innovation system of health service of traditional Chinese medicine, enrich the types of health service products of traditional Chinese medicine, broaden the service fields, and improve Improve the ability and level of health service of traditional Chinese medicine On August 24, the State Food and Drug Administration issued the guiding opinions on the construction of drug information traceability system (Draft for comments), which made it clear that the holders of drug listing licenses (including drug manufacturers with drug approval numbers) are the responsible subjects for the construction of drug traceability system; multiple codes are allowed to coexist, and the enterprises can choose independently; the regulatory department is responsible for supervision and guidance At the same time, promote the interconnection of traceability information On August 31, the State Administration of market supervision and administration and the state health and Health Commission jointly issued the administrative measures for monitoring and reevaluation of adverse events of medical devices, which clearly stated that the holders of the registration certificate and the record certificate of medical devices should bear the main responsibility, and the agents designated by the overseas holders should bear the monitoring and reevaluation obligations for the imported medical devices sold in China 。
On September 13, the long-awaited special specifications for Internet diagnosis and treatment, Internet hospitals and telemedicine finally had standards Measures for the administration of Internet diagnosis and treatment (for Trial Implementation), measures for the administration of Internet hospitals (for Trial Implementation) and norms for the administration of telemedicine services (for Trial Implementation) are jointly issued by the state health and Health Commission and the State Administration of traditional Chinese medicine, which respectively regulate and require the Internet diagnosis and treatment services, the establishment of Internet hospitals and the services of telemedicine On September 13, the national health and Health Commission issued the notice on printing and distributing the national health and medical big data standards, safety and service management measures (for Trial Implementation), which made it clear that the responsible units should strengthen the use and service of health and medical big data, create conditions to standardize the use of health and medical big data, and promote online query of some health and medical big data On September 14, the measures for the administration of clinical application of medical technology was discussed and adopted, and shall be implemented as of November 1 this year The National Health Care Commission issued the administrative measures for clinical application of medical technology in accordance with departmental regulations, aiming at strengthening the top-level design of clinical application management of medical technology, establishing relevant management systems and working mechanisms for clinical application of medical technology, strengthening the main responsibility of medical institutions in clinical application management of medical technology and the supervision responsibility of the administrative department of health On September 19, the general office of the State Council issued the opinions on improving the national basic drug system We will improve policies on the selection, production, circulation, use, payment and monitoring of essential drugs, comprehensively promote the construction of drug supply guarantee system, strive to ensure the safety and effectiveness of drugs, reasonable prices and adequate supply, and alleviate the problem of "expensive medical treatment" On September 20, the fourth meeting of the Central Committee for comprehensive deepening reform deliberated and passed the opinions on reforming and improving the vaccine management system, proposing to take strong measures, strictly enforce market access, strengthen market supervision, etc.; give play to the leading role of state-owned enterprises and large backbone enterprises, and strengthen vaccine research and development innovation, technology upgrading and quality management On September 23, the medical administration and medical administration bureau of the National Health Commission issued the guiding principles for the clinical application of new anti-tumor drugs (2018 version) to classify anti-tumor drugs into general use level and restricted use level according to drug indications, drug accessibility and tumor treatment value In July 5th, the Tianjin Planning Commission issued the "implementation of the Internet plus medical health" (Draft) It was proposed that we should open up the information channel outside the hospital, and realize the interconnection and sharing of the prescription information and the retail consumption information of the medical institutions On July 10, Shanghai Municipality carried out the major measures of the state to further expand the opening up and accelerated the establishment of a new open economic system action plan (referred to as "100 articles of Shanghai's expanding opening up") The document proposes to comprehensively promote the construction of the import hub port for pharmaceutical and medical devices, including striving for new anti-tumor drugs that are urgently needed in clinical practice and have been listed abroad and have not been approved for registration of the same kind of products in China, and using them at designated points in Shanghai in advance On July 22, Qinghai Province issued the guiding opinions on promoting the development of Tibetan medicine industry in Qinghai Province By 2020, a modern Tibetan medicine industry system with relatively sufficient raw material supply, strong innovation ability and complete industrial chain will be established By 2025, the leading position in the development of Tibetan medicine in China will be more consolidated and a strong Tibetan medicine province will be built in an all-round way On July 25, the general office of Jiangsu provincial government issued the opinions on the implementation of the reform and improvement of the training and use incentive mechanism of general practitioners, which proposed to speed up the cultivation of a large number of qualified general practitioners, give full play to the role of general practitioners, improve the grass-roots medical and health service system, promote the signing service of family doctors, establish a hierarchical diagnosis and treatment system, and maintain and improve the health of the people On August 8, Guangdong health and Family Planning Commission issued the notice on Strengthening Drug Administration and drug control in medical institutions to promote the high-quality development of pharmaceutical care (Draft for comments) According to the opinion draft, we should further strengthen the management of pharmaceutical affairs in medical institutions, strengthen the rational use of drugs and drug control fees, and promote the transformation and development of pharmaceutical services According to the document, Guangdong Province will promote the implementation of the chief pharmacist system On August 12, the people's Government of Fujian Province issued the implementation opinions on reforming and improving the supply guarantee and use policy of generic drugs It gives strong support to the research and development, production, use, tax and other aspects of generic drugs Imitation is to replace, once again pushed On August 14, Shanghai food and Drug Administration issued the implementation guide of Shanghai medical device registrant's entrusted production quality management system (Trial) The implementation guide focuses on standardizing the entrusted production quality management of medical device registrants, clarifying the division of quality management responsibilities among different subjects, and guiding medical device registrants, entrusted production enterprises and inspectors to carry out quality system management and verification On August 13, the general office of the Party committee and the general office of the government of Guangxi Zhuang Autonomous Region issued the implementation plan for deepening the reform of the review and approval system in Guangxi to encourage the innovation of pharmaceutical and medical devices, and deployed to promote the industrial restructuring and technological innovation of pharmaceutical and medical devices On August 22, the State Drug Administration approved the pilot work plan of Guangdong medical device registrant system According to the plan, in the future, medical device registration applicants in Guangzhou, Shenzhen and Zhuhai can entrust Guangdong medical device manufacturing enterprises to produce products, allow medical device R & D institutions and researchers to apply for medical device listing license, and make a breakthrough in exploring the management mode of separation of medical device product registration and production license On August 29, the Sichuan Provincial Health and Family Planning Commission issued the opinions of the general office of the Sichuan Provincial People's Government on the implementation of the reform and improvement of the supply guarantee and use policy of generic drugs (Draft for comments) It was proposed that the provincial enterprises should give appropriate awards to the top three varieties that have passed the consistency evaluation of quality and efficacy in the country, and the municipal (prefecture) people's governments should give corresponding incentives according to the actual situation On September 4, the official website of Shanghai food and Drug Administration released the implementation opinions of Shanghai food and Drug Administration on deepening the reform of "release management service" and optimizing the administrative examination and approval, as well as the list of optimization administrative examination and approval items of Shanghai food and drug administration In Item 9 "drug re registration" of the list, it is clear that "strengthen the in-process and post registration supervision of re registered drugs", "do not re register the oral preparations in the national essential drug catalog that fail to pass the consistency evaluation" and "eliminate the drugs in the national essential drugs that fail to meet the requirements of the oral solid preparations" On September 10, the Hebei provincial government issued the implementation opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices The implementation opinions is divided into 7 parts and 29 specific measures, including reforming the clinical trial management, accelerating the review and approval of listing, promoting the innovation of medical devices and the development of generic drugs, strengthening the whole life cycle management of medical devices, improving the technical support capacity of review and approval, strengthening the cooperation of the pharmaceutical industry in Beijing, Tianjin and Hebei, and strengthening the organization and implementation On September 17, the general office of Jiangsu provincial Party committee issued the implementation opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical medical devices, and put forward 26 measures simultaneously, which not only encourages the innovation of pharmaceutical medical devices, but also supports the imitative production of drugs, so that people can use more life-saving drugs and rest assured drugs The main suggestions are to reform the management of clinical trials, accelerate the review and approval of the listing, and promote the innovation of pharmaceutical and medical devices