Eight departments stand up for medical innovation in the Great Bay Area

November 25, the General Administration of Market Supervision, the State Drug Administration, the National Development and Reform Commission, the Ministry of Commerce, the National Health and Health Commission, the General Administration of Customs, the Hong Kong and Macao Affairs Office of the State Council, the State Administration of Traditional Chinese Medicine and other eight departments jointly issued the Guangdong, Hong Kong and Macao Bay Area Drug Medical Device Regulatory Innovation and Development Work Programme (the "Work Programme"), clearly promote the guangdong, Hong Kong and Macao Bay Area drug medical device regulatory innovation and development, explore the establishment of interactive and mutually beneficial drug medical device cooperation and new models.The Work Programme proposes to promote the docking of the regulatory mechanism between Guangdong, Hong Kong and Macao, to establish a regulatory system covering the management of the whole process of procurement, import, customs clearance, storage, distribution and use between the nine mainland cities and Hong Kong and Macao in the Greater Bay Area, and to designate medical institutions to use drugs that are clinically urgently needed and have been listed in Hong Kong and Macao, which shall be approved by the State Drug Administration and approved by the Guangdong Provincial People's Government authorized by the State Council.In fact, from the national purchase amount of pharmaceutical and medical equipment supplies, Guangdong Province is a major province of pharmaceutical procurement. According to data released by the Guangdong Drug Trading Center, the amount of drug transactions in Guangdong Province exceeded 90 billion yuan/year for three consecutive years, plus the purchase amount of consumables, the "100 billion market" is worthy of its name.The industry generally believes that the release of the new policy means that the "hundreds of billions of markets" for the global innovation of pharmaceutical products to increase the opening up efforts, conducive to the rapid entry of global innovative products into the Chinese market, so that patients can use in a timely manner, affordable clinically urgently needed pharmaceutical products, enjoy the dividends of global pharmaceutical innovation.

international innovation to meet the needs of theIn May last year, the Director general of the State Drug Administration, Jia Hong, pointed out in Guangdong Province to investigate the construction of guangdong, Hong Kong, Macao and the Great Bay Area, the State Drug Administration with a high sense of responsibility and mission, effectively strengthen drug supervision work, promote drug industry research and development innovation, continue to deepen the reform of the review and approval system, increase support for pharmaceutical industry research and development innovation in the Bay Area, help the pharmaceutical industry in the Bay Area high-quality development, to meet the needs of the public for pharmaceutical equipment.In order to strengthen exchanges and cooperation in the areas of medicine, medical equipment and chinese medicine supervision, the State Drug Administration and the Food and Health Bureau of the Government of the Hong Kong Special Administrative Region have signed the Agreement on Cooperation in the Field on Drug Supervision and the Cooperation Agreement on the Construction, Research and Management of Chinese Medicine Specimens Museum to strengthen exchanges and cooperation in relevant fields to safeguard the health of the people of Guangdong, Hong Kong, Macao and the Gulf Region.The newly released Work Programme proposes to speed up the construction of the Dawan Divisional Center for Drug and Medical Device Review and Inspection of the State Drug Administration, which will act as the dispatching agency of the Drug and Medical Device Review Center of the State Drug Administration, and will mainly undertake to assist the Drug and Medical Device Review Agency of the State Drug Administration in carrying out the communication guidance and related inspection in the event of review, and establish a convenient mechanism for review and approval.It is worth noting that, as the key task of the Work Programme, the pilot of the import audit of innovative products listed in Hong Kong and Macao will be carried out in 9 cities in the Mainland of Guangdong, Hong Kong, Macao and the Bay Area:First, the use of clinically urgently needed drugs in designated medical institutions opened in 9 cities in the Mainland of the Great Bay Area, which have been listed in Hong Kong and Macao, will be approved by the State Drug Administration and approved by the Guangdong Provincial People's Government authorized by the State Council;Ii is to suspend the implementation of Article 11(2) of the Regulations on the Supervision and Administration of Medical Devices in 9 cities in the Mainland of the Greater Bay Area, and the approval of the Guangdong Provincial People's Government shall approve the use of medical devices that are urgently needed for clinical use by designated medical institutions opened in the region, and that have been procured and used by public hospitals in Hong Kong and Macao, with advanced clinical applications.Experts said that the drug management legal system of the Hong Kong Special Administrative Region is characterized by parallel management, with separate legislation according to different categories of medicines, such as Chinese medicine being regulated by the Chinese Medicine Ordinance, Western medicine being regulated by the Pharmacy and Poisons Ordinance, and some of the regulations being scattered among the regulations such as the Import and Export Regulations, the Dangerous Drugs Regulations and the Bad Medicine Advertising Ordinance;As drug regulatory policies in Hong Kong and Macau were earlier in line with international standards, the International Coordinating Conference (ICH) guidelines for the technical requirements for the registration of human-used drugs were followed in clinical trials, import regulations and post-market regulations. Once global innovative drugs have been approved by overseas regulators and want to enter the Hong Kong and Macau markets for sale, the regulatory process is more flexible.With the former State Food and Drug Administration (CFDA) officially joining ICH in 2017, the reform of pharmaceutical innovation review and approval has been deepened, and the speed of approval and listing of innovative drugs has continued to accelerate. At the same time, in 2018, the State Council allowed the use of domestic not yet registered, foreign marketed innovative pharmaceutical products in the boao Lecheng advance area of Hainan Province, the number of imported licensed drug varieties in the advance area continued to increase, the global special regulatory experience of innovative drugs has been accumulated.Industry analysis points out that Hong Kong and Macao accept international multi-center clinical data, "work programme" will be clinically urgently needed, has been listed in Hong Kong and Macao drugs into the Great Bay Area innovation and regulatory exploration, enterprises should actively grasp the opportunity to focus on and grasp China's unsoponsed clinical needs, take the initiative to improve the quality of drug research and development, actively carry out international multi-center clinical trials, save product cost and time cycle.

opportunities for upgrading the Chinese medicine industryUnder the background of modernization and internationalization of Chinese medicine, the integration of advantageous resources in the Great Bay Area to build medical highlands, promote integration and development to create innovative highlands, consolidate the development base to build talent highlands, deepen mutually beneficial cooperation to build industrial highlands, and help the "Belt and Road" to build international highlands and other major tasks, has become the focus of the development of regional Chinese medicine industry.   The "Work Programme" issued this time also puts forward the goal of upgrading the Chinese medicine industry in terms of inheriting innovation, radiation development and leading the way. The document proposes to support the development of the Chinese medicine industry in Hengqin Guangdong-Australia Cooperative Chinese Medicine Science and Technology Industrial Park and to simplify the registration and approval process for foreign Chinese medicine. The State Drug Administration entrusted the Guangdong Provincial Drug Administration to approve traditional Chinese medicines that have been listed in Hong Kong and Macao, and the specific catalogue shall be formulated by the Guangdong Provincial Drug Administration and reported to the State Drug Administration for the record.   In addition, we will focus on promoting the innovation and research and development of Chinese medicine products, support the establishment of an incubation center for innovation in Chinese medicine products in the Hengqin Guangdong-Australia Cooperative Chinese Medicine Science and Technology Industrial Park, encourage Chinese medicine medical institutions to develop medical institutions in the industrial park, and encourage the research and development of Chinese medicine medical devices in the industrial park.   At the same time, in order to further strengthen chinese medicine policy and technical research, the Guangdong Provincial Drug Administration, the Southern Pharmaceutical Economic Research Institute of the State Drug Administration and Hengqin Guangdong-Australia Cooperative Chinese Medicine Science and Technology Industrial Park jointly carry out Chinese medicine standards and international exchange strategies and other policy and technical research, build a platform for Chinese medicine policy and technical research, exchange and dissemination, in order to speed up the improvement of the Chinese medicine policy system, promote the development of Chinese medicine, and promote the standardization, modernization and internationalization of Chinese medicine.   Prior to this, Hainan Boao Lecheng International Medical Tourism Advance District Management Bureau Director Gu Gang in an interview with the media admitted: "Lecheng advance area construction early, multinational pharmaceutical companies do not want to see us, enterprises feel that Lecheng is too small, the market development can not get up." However, Lecheng's 'first try' provides an observational sample and also reaps a lot of replicable and replicable experience. " Now, China's pharmaceutical regulatory innovation ecology is constantly improving, the global experience of innovative products regulatory more mature, in the face of "hundreds of billions of levels" of regional market opportunities, innovative enterprises, multinational enterprises, Chinese medicine enterprises how to grasp the future is very worth looking forward to!   The Work Programme on The Regulatory Innovation and Development of Pharmaceutical Medical Devices in Guangdong, Hong Kong and Macao for the in-depth implementation of the Outline of the Guangdong, Hong Kong and Macao Development Plan, to promote the development of drug medical device regulatory innovation in Guangdong, Hong Kong and Macao, to explore the establishment of a new model of mutually beneficial cooperation in pharmaceutical medical devices, to enhance the level of modernization of regulatory systems and capabilities, and to formulate this program.

, the overall requirements (1) Guiding ideology.   Guided by Xi Jinping's thought of socialism with Chinese characteristics in the new era, we will deeply implement the spirit of General Secretary Xi Jinping's important directive on the construction of the Guangdong, Hong Kong and Macao Bay Area and the "four most stringent" requirements, adhere to the new development concept, further promote the reform of "discharge and service", innovate the way of supervision of pharmaceutical medical devices, integrate regulatory resources, promote the integration and development of the pharmaceutical industry in guangdong, Hong Kong and Macao, and better meet the needs of residents of Guangdong, Hong Kong and Macao Bay Area for the use of medicinal equipment. (ii) Basic principles.   Adhere to "one country, two systems" and act in accordance with the law. We will combine the maintenance of the national drug and medical device regulatory system with respect for the differences between the regulatory mechanisms of Hong Kong and Macao, promote the interface of the regulatory mechanisms of Guangdong, Hong Kong and Macao, promote the innovation and development of pharmaceutical medical devices, and achieve the common development of the pharmaceutical industry in guangdong, Hong Kong and Macao.   We will continue to share development and improve people's livelihood. Adhering to the people-centered development thought, focusing on the needs of residents of Guangdong, Hong Kong and Macao Bay Area, through innovative drug medical device supervision, and constantly provide quality pharmaceutical medical equipment and services, so that the residents of Guangdong, Hong Kong and Macao Dawan District to obtain a sense of well-being, happiness, security more substantial, more secure and more sustainable.   Insist on step-by-step implementation, pilot first. In view of the demand for imported pharmaceutical medical devices in the Mainland of Guangdong, Hong Kong and Macao Bay Area, in order to strengthen supervision and ensure safety, and adhere to step-by-step implementation, the first phase of some more mature conditions in some places and medical institutions as a pilot, after obtaining replicable, replicable experience extended to Guangdong, Hong Kong and Macao Bay Area other eligible regional and medical institutions. (iii) Overall objectives.   By 2022, we will basically establish an institutional mechanism for the use of Hong Kong and Macao-listed pharmaceutical medical devices by mainland medical institutions in Guangdong, Hong Kong and Macao, and basically provide high-level medical equipment conditions for Hong Kong and Macao, and build a "soft connectivity" mechanism for the research, development, production, circulation and use of pharmaceutical medical devices in the Mainland and Hong Kong and Macao in Guangdong, Hong Kong and Macao. Hong Kong and Macao Dawan District pharmaceutical industry integration and development, and actively and steadily carry out hong Kong and Macao foreign chinese medicine review and approval, Hong Kong and Macao pharmaceutical medical equipment production in the Great Bay Area mainland pilot work;   By 2035, establish a sound regulatory coordination mechanism for pharmaceutical medical devices in Guangdong, Hong Kong, Macao and the Greater Bay Area to facilitate drug medical device products and services for mainland residents of Hong Kong, Macao and the Greater Bay Area;

, key tasks, (1) The use of clinically urgently needed drugs by designated medical institutions opened in 9 cities in the Mainland of Guangdong, Hong Kong and Macao Bay Area shall be approved by the State Drug Administration and approved by the Guangdong Provincial People's Government authorized by the State Council.   One is the scope of implementation. About the scope of designated medical institutions. The main body of medical and health services provided by Hong Kong and Macao is set up in 9 cities in the Mainland of Guangdong, Hong Kong and Macao Bay Area by way of sole proprietorship, joint venture or cooperation, and is approved and determined by the Guangdong Provincial Health and Health Commission. Insist on step-by-step implementation, the first phase of the University of Hong Kong Shenzhen Hospital as a pilot, after the progress achieved gradually expanded to other designated medical institutions that meet the requirements. The relevant approved conditions and procedures shall be formulated by the Guangdong Provincial Health and Health Commission. About the scope of the catalogue of imported medicines. By the Guangdong Provincial Health and Health Commission, the Drug Administration in cooperation with the Hong Kong and Macao health departments in accordance with clinical needs and drug market conditions to determine the list of imported drugs, and carry out dynamic adjustments.   Second, the implementation of procedures. About import approval. Designated medical institutions to apply for clinical drug demand, Guangdong Provincial Health and Health Commission issued an audit opinion based on the application, assessment of whether the proposed import of drugs is a clinical urgent need. If a designated medical institution, in accordance with the examination opinions, puts forward an import application to the Guangdong Provincial Drug Administration and meets the requirements, the approval shall be issued by the Guangdong Provincial Drug Administration. About customs clearance management. The designated medical institution shall apply to the Drug Administration of the Mainland Port of Guangdong, Hong Kong and Macao for the customs clearance of imported drugs on the basis of the approval, and the Customs shall go through the customs clearance procedures in accordance with the provisions