Eight departments to support the Great Bay Area pharmaceutical innovation! Hundreds of billions of markets are open to the world!

On 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, Macao, Dawan District 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 new model.
The Work Programme proposes to promote the docking of guangdong, Hong Kong and Macao regulatory mechanisms, establish a regulatory system covering the whole process of procurement, import, customs clearance, storage, distribution and use between the nine mainland cities of the Greater Bay Area and Hong Kong and Macao, 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.
fact, from the national procurement of pharmaceutical and medical equipment supplies, Guangdong Province is a major province of pharmaceutical procurement.
according to data previously 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 new policy announcement means that the "hundreds of billions of markets" for the global innovation of pharmaceutical products to increase the intensity of opening up, 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.
Internationalization and innovation to meet the big market last May, the Director general of the State Drug Administration, Jia Hong, in Guangdong Province to investigate the construction of Guangdong, Hong Kong, Macao and the Great Bay Area, pointed out that the State Drug Administration with a high sense of responsibility and mission, effectively strengthen drug supervision work, promote research and development innovation in the pharmaceutical industry, continue to deepen the reform of the review and approval system, increase support for the 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 the supervision of Chinese medicine, the State Drug Administration and the Food and Health Bureau of the Hong Kong Special Administrative Region Government 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 serve as the dispatch office 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 work of communication guidance and related inspections 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 guangdong, Hong Kong, Macao and the Bay Area: First, the designated medical institutions opened in 9 cities in the Greater Bay Area will use clinically urgently needed drugs that have been listed in Hong Kong and Macao, and will be The approval of the Supervisory Bureau shall be approved by the Guangdong Provincial People's Government authorized by the State Council, and the second 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 Dawan District, and the medical devices that are urgently needed for use by designated medical institutions opened in the region, which have been procured and used by public hospitals in Hong Kong and Macao, and have advanced clinical applications, shall be approved by the Guangdong Provincial People's Government.
experts said that the hong Kong Special Administrative Region's drug management legal system is characterized by parallel management, according to different categories of drugs, such as Chinese medicine by the Chinese Medicine Ordinance, Western medicine by the Pharmaceutical Industry and Poisons Ordinance, some of the regulations are also scattered in the Import and Export Regulations, the Dangerous Drugs Ordinance, the Bad Medicine Advertising Ordinance and other regulations;
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 are followed in clinical trials, import regulations and post-market regulation.
the global innovative drugs once approved by overseas regulators, want to enter the Hong Kong and Macao markets for sale, the regulatory process is more flexible.
with the former State Food and Drug Administration (CFDA) officially joined ICH in 2017, the reform of pharmaceutical innovation review and approval gradually deepened, and the speed of approval and listing of innovative drugs continued to accelerate.
At the same time, in 2018, the State Council allowed the use of domestically unregistered and foreign-listed innovative pharmaceutical products in the boao Lecheng Advance Zone of Hainan Province, and the number of imported licensed drug varieties in the Advance Zone continued to increase, and the special regulatory experience of innovative drugs worldwide continued to accumulate.
Industry analysis pointed 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 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 launch costs and time cycle.
Under 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 the regional Chinese medicine industry.
the "Work Programme" issued this time, but also in the transmission of innovation, radiation development, leading the way in the upgrading of the Chinese medicine industry to put forward goals.
document proposed to support the development of 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-used Chinese medicine.
The State Drug Administration commissioned 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 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, 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 le city is too small, the market development can not be up."
, 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 in the future how to grasp is very worth looking forward to! The Work Programme for the Regulatory Innovation and Development of Pharmaceutical Medical Devices in Guangdong, Hong Kong and Macao, in order to further implement the Outline of the Development Plan for the Guangdong, Hong Kong and Macao Bay Area, promote the development of drug medical device regulatory innovation in Guangdong, Hong Kong and Macao, explore the establishment of a new model of mutually beneficial cooperation in pharmaceutical medical devices, and upgrade the level of modernization of the regulatory system and capabilities.
, the overall requirements (i) 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 in accordance with the decision-making and deployment of the CPC Central Committee and the State Council, further promote the reform of "discharge and clothing", 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 areas for drug use.
(ii) basic principles.
adhere to "one country, two systems" and act in accordance with the law.
combines maintaining the national drug and medical device regulatory system with respecting the differences between the regulatory mechanisms of Hong Kong and Macao, promoting the interface between the regulatory mechanisms of Guangdong, Hong Kong and Macao, promoting the innovation and development of pharmaceutical medical devices, and realizing the common development of the pharmaceutical industry in guangdong, Hong Kong and Macao.
to share development and improve people's livelihood.
Adhere to the people-centered development ideas, around 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 Guangdong, Hong Kong and Macao Bay Area residents to obtain a sense of well-being, happiness, security more substantial, more secure and more sustainable.
to 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 places and medical institutions as a pilot, after obtaining replicable and replicable experience extended to Guangdong, Hong Kong and Macao Bay Area other eligible regional and medical institutions.
(iii) overall objectives.
By 2022, the basic establishment of Guangdong, Hong Kong, Macao and the Bay Area mainland medical institutions to use Hong Kong and Macao listed pharmaceutical medical equipment system, Guangdong, Hong Kong and Macao Bay Area Mainland designated medical institutions basically have to provide Hong Kong and Macao with a high level of medical equipment conditions; Promote the integration and development of the pharmaceutical industry in Guangdong, Hong Kong and Macao, actively and steadily carry out the pilot work of review and approval of Traditional Chinese medicines for foreign use in Hong Kong and Macao, and the production of pharmaceutical medical equipment in the Mainland of the Great Bay Area;
By 2035, establish a sound regulatory coordination mechanism for pharmaceutical medical devices in Guangdong, Hong Kong and Macao, and the Mainland residents of Hong Kong, Macao and the Greater Bay Area to facilitate pharmaceutical medical device products and services;
II. Key tasks (1) The use of clinically urgently needed drugs listed in Hong Kong and Macao by designated medical institutions opened in 9 cities in the Mainland of Guangdong, Hong Kong and Macao shall be approved by the State Drug Administration and approved by the Guangdong Provincial People's Government authorized by the State Council.
is the scope of implementation.
about the scope of designated medical institutions.
hong Kong and Macao medical and health services providers in Guangdong, Hong Kong and Macao Inland 9 cities by sole proprietorship, joint venture or cooperation, and by the Guangdong Provincial Health and Health Commission to determine the medical institutions.
to a step-by-step implementation, with the University of Hong Kong Shenzhen Hospital as a pilot, and gradually expanded to other designated medical institutions that meet the requirements after making progress in stages.
conditions and procedures shall be formulated by the Guangdong Provincial Health and Health Commission.
on the scope of the catalogue of imported medicines.
by the Guangdong Provincial Health And Health Commission, the Drug Administration and 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.
is the implementation of procedures.
on import approval.
the designated medical institutions to apply for clinical drug demand, the Guangdong Provincial Health and Health Commission issued an audit opinion on the basis of the application, assessing whether the drugs to be imported are clinically urgent.
the designated medical institution shall, in accordance with the audit opinions, apply to the Guangdong Provincial Drug Administration for import, and if the requirements are met, the approval shall be issued by the Guangdong Provincial Drug Administration.
about customs clearance management.
designated medical institutions to apply to the Mainland Port Drug Administration of Guangdong, Hong Kong, Macao and the Gulf Region for the "Import drug clearance document" on the basis of the approval, and the Customs shall handle customs clearance procedures in accordance with the provisions.
designated medical institutions shall entrust pharmaceutical enterprises to purchase, import and distribute medicines in accordance with the provisions.
(2) The suspension of the implementation of Article 11 (2) of the Regulations on the Supervision and Administration of Medical Devices in nine cities in the Mainland of Guangdong, Hong Kong and Macao, and the approval of the Guangdong Provincial Government shall be for 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.
is to suspend the implementation of the provisions of the statute.
article 11, paragraph 2, of the Regulations on the Supervision and Administration of Medical Devices, "An overseas production enterprise that exports Class II and CLASS III medical devices to China shall be implemented in 9 cities in the Mainland of Guangdong, Hong Kong, Macao and Taiwan by its representative office established in China or by appointing an enterprise legal person within China as an agent, and submit to the Food and Drug Administration Department of the State Council the information of the application for registration and the supporting documents of the competent department of the country (region) where the applicant is registered to be listed for sale".
is the scope of implementation.
about the scope of designated medical institutions.
hong Kong and Macao medical and health services providers in Guangdong, Hong Kong and Macao Inland 9 cities by sole proprietorship, joint venture or cooperation, and by the Guangdong Provincial Health and Health Commission to determine the medical institutions.
to a step-by-step implementation, with the University of Hong Kong Shenzhen Hospital as a pilot, and gradually expanded to other designated medical institutions that meet the requirements after gaining replicable and replicable experience.
conditions and procedures shall be formulated by the Guangdong Provincial Health and Health Commission.
scope of the catalogue of imported medical devices.
Hong Kong and Macao public hospitals have purchased and used medical devices that are urgently needed for clinical use and have advanced clinical applications, and the Guangdong Provincial Health And Health Commission, the Drug Administration and the Hong Kong and Macao Health Department shall determine the catalogue of imported medical devices in accordance with clinical needs and implement dynamic adjustments.
is the implementation procedure.
on import approval.
The designated medical institutions to apply for the use of firearms, Guangdong Provincial Health and Health Commission to assess clinical needs and issued an audit opinion, including whether the proposed import of medical equipment is clinically urgent and no other treatment means, domestic products currently listed can achieve the same therapeutic effect, medical institutions, such as the ability to use equipment.
The Guangdong Provincial Drug Administration evaluates the advanced nature of clinical applications, supports medical devices that are not approved for listing without the same varieties in China, and issues import approval opinions.
Department of Commerce issued import audit opinions on medical devices belonging to large-scale medical equipment in accordance with relevant regulations. <br。