In order to deeply implement the Outline of the Plan for the Development of Guangdong, Hong Kong and Macao Greater Bay Area, and to promote the innovative development of the regulation of medicines and medical devices in Guangdong, Hong Kong and Macao Greater Bay Area, this program is formulated.
The program is designed to promote the innovative development of the regulation of medical devices in Guangdong, Hong Kong and Macao, to explore the establishment of a new model of cooperation in the regulation of medicines and medical devices, and to enhance the modernization of regulatory systems and capabilities.
I. General requirements
(a) Guiding ideology.
Guided by Xi Jinping's thought of socialism with Chinese characteristics in the new era, the implementation of General Secretary Xi Jinping's important instructions on the construction of the Guangdong, Hong Kong and Macao Bay Area and the "four most stringent" requirements, in accordance with the CPC Central Committee and the State Council's decision-making and deployment, adhering to the new concept of development, and in-depth advancement of the "release, control and service" reform. In accordance with the decision-making and deployment of the Party Central Committee and the State Council, we adhere to the new development concept, deeply promote the reform of "release management and service", innovate the regulation of drugs and medical devices, integrate regulatory resources, promote the integration and development of the pharmaceutical industry in the Guangdong, Hong Kong and Macao Bay Area, better meet the demand of the residents of the Guangdong, Hong Kong and Macao Bay Area for medicines and equipment, guarantee the safety of medicines and equipment, and shape the health of the Bay Area with innovation and vitality.
(ii) Basic principles.
Adhere to the "one country, two systems", according to the law. The maintenance of the national drug and medical device regulatory system and respect for the differences between the regulatory mechanisms of Hong Kong and Macao organic combination, to promote the regulatory mechanism of Guangdong, Hong Kong and Macao docking, to promote the innovative development of drugs and medical devices, to achieve the Guangdong, Hong Kong and Macao Bay Area, the common development of the pharmaceutical industry.
Adhere to shared development and improve people's livelihood. Adhering to the people-centered development ideology, focusing on the needs of the residents of Guangdong, Hong Kong and Macao Bay Area, through the innovation of drug and medical device regulatory methods, and constantly provide high-quality drugs and medical devices and services, so that the residents of Guangdong, Hong Kong and Macao Bay Area sense of gain, happiness, sense of security is more fulfilling, more guaranteed, and more sustainable.
Adhering to the step-by-step implementation, pilot first. For the Guangdong, Hong Kong and Macao Bay Area, the demand for imported medicines and medical devices, in order to strengthen the supervision to ensure safety, adhere to the step-by-step implementation, the first in a number of more mature conditions of the local and medical institutions as a pilot, in order to obtain replicable and scalable experience after the expansion of the Guangdong, Hong Kong and Macao Bay Area, the other regions and medical institutions to meet the requirements.
(C) Overall objective.
By 2022, the institutional mechanism for the use of Hong Kong and Macao listed medicines and medical devices by medical institutions in the Guangdong, Hong Kong and Macao Greater Bay Area will be basically established, and designated medical institutions in the Guangdong, Hong Kong and Macao Greater Bay Area will basically be equipped with the conditions for providing high-level medical medicines and medical devices for Hong Kong and Macao; to build a soft connectivity mechanism for the research and development, production, circulation and use of medicines and medical devices between Guangdong, Hong Kong and Macao; and to build a soft connectivity mechanism for the development, production, circulation and use of medicines and medical devices between Guangdong, Hong Kong and Macao. To establish a "soft linkage" mechanism between the R&D, production, circulation and use of medicines and medical devices in Guangdong, Hong Kong and Macao; to promote the integrated development of the pharmaceutical industry in Guangdong, Hong Kong and Macao; to actively and steadily carry out the pilot work of reviewing and approving the use of proprietary Chinese medicines for external use in Hong Kong and Macao, as well as the production of Hong Kong and Macao medicines and medical devices in Guangdong, Hong Kong and Macao; to set up a national technical support organization for medicines and medical devices, and to promote the rapid and healthy development of the pharmaceutical industry of Guangdong, Hong Kong and Macao; and, by leveraging on the advantage of the internationalization of Guangdong, Hong Kong and Macao Promote the standardization, modernization and internationalization of Chinese medicine.
By 2035, a comprehensive regulatory and coordination mechanism for pharmaceutical and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area will be established, providing convenient pharmaceutical and medical device products and services for Hong Kong, Macao and local residents in the Greater Bay Area; a high-level scientific and technological innovation platform for the pharmaceutical industry in the Greater Bay Area will be built, realizing the in-depth integration of the pharmaceutical industry in Guangdong, Hong Kong and Macao and the upgrading of the pharmaceutical and medical device manufacturing industry, and building a model area for the innovation and development of the pharmaceutical industry and a livable and pleasant place to live and work in.
Second, the key tasks
(a) in Guangdong, Hong Kong and Macao Bay Area, nine cities in the designated medical institutions operating in the use of clinically urgent, has been listed in Hong Kong and Macao drugs, from the State Drug Administration approved by the State Council authorized the Guangdong Provincial People's Government to approve.
First, the scope of implementation. On the scope of the designated medical institutions. Hong Kong and Macao health care service providers in Guangdong, Hong Kong and Macao in the Bay Area 9 city to wholly-owned, joint venture or cooperation and other ways to set up, and by the Guangdong Provincial Health Commission audit identified medical institutions. Adhering to the step-by-step implementation, the University of Hong Kong Shenzhen Hospital will be taken as a pilot project at the initial stage, and will be gradually extended to other designated medical institutions that meet the requirements after making progress in a phased manner. The relevant approved conditions and procedures will be formulated by the Guangdong Provincial Health Commission. On the scope of the imported drug catalog. The Guangdong Provincial Health Commission, Drug Administration, in conjunction with Hong Kong and Macao health departments to determine the imported drugs catalog based on clinical needs and the listing of drugs, and the implementation of dynamic adjustment.
Second, the implementation of the program. On the import approval. Designated medical institutions to put forward the clinical needs of the application, Guangdong Provincial Health Commission based on the application to issue an audit opinion, the assessment includes the proposed importation of drugs are clinically urgent. Designated medical institutions according to the audit opinion to the Guangdong Provincial Drug Administration to submit an application for import, meet the requirements of the Guangdong Provincial Drug Administration to issue approvals. On the management of customs clearance. With the approval document, the designated medical institution applies to the Drug Administration of Guangdong, Hong Kong and Macao ports to apply for the "Imported Drugs Customs Clearance Order", and the Customs will carry out the customs clearance procedures according to the regulations. The designated medical institutions entrusted the procurement, import and distribution of drugs to pharmaceutical enterprises in accordance with the regulations.
(b) In Guangdong, Hong Kong and Macao Bay Area, nine cities suspend the implementation of the "supervision and management of medical devices regulations" Article 11, paragraph 2, the region opened designated medical institutions to use the clinical urgency, Hong Kong and Macao public hospitals have been procured and used, with advanced clinical application of medical devices, approved by the Guangdong Provincial Government.
First, suspend the implementation of regulatory provisions. Temporarily adjust the "supervision and management of medical devices regulations" Article 11, paragraph 2 "to export to China's territory of the second class, the third class of medical devices overseas manufacturers, should be set up by its representative body in China or designated as an agent of China's domestic enterprises as a legal person, to the State Council's food and drug supervision and management department to submit the application for registration of information and the registration of the applicant's country (or region), the competent authorities to authorize the marketing of the medical device. The "certification of the competent authorities of the country (region) where the registered applicant is located to authorize the marketing of the medical device" is implemented in nine cities in Guangdong, Hong Kong and Macao.
Second, the scope of implementation. The scope of the designated medical institutions. Hong Kong and Macao health care service providers in Guangdong, Hong Kong and Macao within the Bay Area, 9 cities to wholly-owned, joint ventures or cooperation and other ways to set up, and by the Guangdong Provincial Health Commission to determine the audit of the medical institutions. Adhering to the step-by-step implementation, the University of Hong Kong Shenzhen Hospital will be taken as a pilot, and will be gradually extended to other designated medical institutions that meet the requirements after obtaining replicable and scalable experience. The relevant approved conditions and procedures will be formulated by the Guangdong Provincial Health Commission. Regarding the scope of the catalog of imported medical devices. Hong Kong and Macao public hospitals have been purchased and used, belonging to the clinical urgency, with advanced clinical application of medical devices, by the Guangdong Provincial Health Commission, the Drug Administration in conjunction with Hong Kong and Macao health departments to determine the imported medical equipment catalog according to the clinical needs, and the implementation of dynamic adjustment.
Third, the implementation of the program. On the import approval. Designated medical institutions to apply for the use of equipment, Guangdong Provincial Health Commission to assess the clinical needs and issue an audit opinion, the assessment includes the proposed import of medical devices are clinically urgent and no other means of treatment, the domestic currently listed products can achieve the same therapeutic effect, the ability to use the device of the medical institutions. Guangdong Provincial Bureau of Pharmaceutical Administration assesses the advanced clinical application, supports the medical devices which have not been approved to be registered and marketed domestically, and issues the approval opinion for import. Guangdong Provincial Department of Commerce in accordance with the relevant provisions of the medical devices belonging to the large-scale medical equipment issued by the import audit opinion. Management of customs clearance. Designated medical institutions with the approval of the Guangdong Provincial Drug Administration (belonging to the medical devices of large-scale medical equipment should also provide the Guangdong Provincial Department of Commerce issued by the import audit opinion) to apply for medical equipment import customs clearance, Guangdong Customs in accordance with the provisions of the verification and release. Designated medical institutions in accordance with the provisions of the entrusted medical equipment business enterprises to purchase, import and distribution of medical equipment.
(C) to accelerate the State Drug Administration drugs and medical devices review and inspection of the construction of the center in the Bay Area. The center as the State Drug Administration drugs and medical devices review center of the sending institutions, mainly responsible for assisting the State Drug Administration drugs and medical devices review agencies to carry out the review of the pre-trial communication and guidance and related inspections and other work, the establishment of review and approval of the convenience of the mechanism.
(d) Support the development of Chinese medicine industry in Hengqin Guangdong-Macao Cooperation in Traditional Chinese Medicine Science and Technology Industrial Park. Firstly, the registration and approval process of proprietary Chinese medicines for external use has been simplified. The State Drug Administration (SDA) has entrusted the Guangdong Provincial Drug Administration (GDDA) with the approval of traditional proprietary Chinese medicines for external use that have been marketed in Hong Kong and Macao, and the specific catalog will be formulated by the GDDA in consultation with Hong Kong and Macao's drug regulatory authorities and reported to the SDA for the record. Secondly, to promote innovative research and development of Chinese medicine products. It supports the establishment of a Chinese medicine product innovation and incubation center in the Hengqin Guangdong-Macao Cooperation Chinese Medicine Science and Technology Industrial Park, encourages Chinese medicine medical institutions to develop medical institution preparations in the industrial park, and encourages the research and development of Chinese medicine medical devices in the industrial park. Thirdly, strengthening research on Chinese medicine policies and technologies. By the Guangdong Provincial Drug Administration, the State Drug Administration Southern Institute of Pharmaceutical Economics and Hengqin Guangdong-Macao Cooperation Chinese Medicine Science and Technology Industrial Park to jointly carry out policy and technology research on Chinese medicine standards and international exchange strategies, to build a platform for research, exchange and dissemination of Chinese medicine policy and technology, to accelerate the improvement of the construction of the policy system of traditional Chinese medicine, to promote the development of the cause of traditional Chinese medicine, and to promote the standardization, modernization and internationalization of traditional Chinese medicine.
(E) In the Guangdong, Hong Kong and Macao Bay Area to carry out the reform of the system of drug listing license holders and medical device registrants. If a pharmaceutical listing licensee or a medical device registrant is a Hong Kong or Macao enterprise, the designated Hong Kong and Macao enterprises in the Guangdong, Hong Kong and Macao Bay Area will be held jointly and severally liable with the relevant Hong Kong and Macao enterprises for fulfilling the obligations of the pharmaceutical listing licensee or the medical device registrant. Support for Hong Kong and Macao drug listing license holders, medical device registrants will hold the drug medical device in Guangdong, Hong Kong and Macao Bay Area, nine cities in the production of eligible enterprises.
(F) In Zhongshan City, the establishment of a port of entry for the import of drugs. In accordance with the procedures declared in Zhongshan City, Guangdong Province, an additional port of importation of drugs, assessment and demonstration of the Guangdong Provincial Drug Inspection Institute Zhongshan laboratory as a port of drug testing.
Third, safeguard measures
(a) the establishment of a collaborative mechanism. The State Administration of Market Supervision, the State Drug Administration, in conjunction with the National Development and Reform Commission, the Ministry of Commerce, the National 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 relevant departments to coordinate and promote the implementation of the relevant work. The People's Government of Guangdong Province takes the lead in establishing a collaborative mechanism within Guangdong Province and with the governments of Hong Kong and Macao Special Administrative Regions, and is specifically responsible for the implementation of the work. The State Drug Administration guides the Guangdong Provincial Drug Administration with Hong Kong and Macao drug supervision and other departments to establish a Guangdong, Hong Kong and Macao drug supervision and collaboration mechanism, to study and determine the important matters of collaboration, to regularly inform the regulatory situation, and to dynamically adjust the permitted use of pharmaceutical and medical equipment catalogs and scope.
(ii) Improvement of supporting systems. The Guangdong Provincial Bureau of Pharmaceutical Supervision, together with the relevant parties, will sort out the list of supporting systems for innovative regulation of pharmaceutical and medical devices, and formulate supporting systems and management methods for the procurement, import, customs clearance, storage, distribution and use of pharmaceutical and medical devices in the Guangdong, Hong Kong and Macao Bay Area according to the functions of the designated healthcare institutions, clarify the conditions for recognition of the designated healthcare institutions, regulate the procedures for importing clinically needed pharmaceutical and medical devices and the conditions of use, and refine the storage, maintenance, and use of the devices. Refine the requirements for storage, maintenance and management, and clarify the contents of adverse reactions, adverse event monitoring and emergency response. Involving the Mainland to Hong Kong and Macao separate opening measures, into the Mainland and Hong Kong, Macao "on the establishment of closer economic and trade relations arrangements" (CEPA) framework for implementation.
(C) Implementation of regulatory responsibility. Guangdong Province, the relevant functional departments in accordance with the proposed supporting system for strict review and approval, so that the application conditions, declaration materials, import customs clearance process and the use of management, etc., the same, the approval standard is not lowered, to prevent the management of clinically urgent imports of drugs and medical equipment out of control. Accelerate the construction of the clinical urgency of imported drugs and medical devices regulatory information platform, the establishment of covering procurement, import, customs clearance, storage, distribution, use of the whole process of management of the traceability system, the realization of drugs and medical devices can be traced back to the source, whereabouts can be traced back to the risk of controllable, responsible for investigable. Strengthen daily supervision and inspection, and explore the implementation of measures such as hierarchical supervision and "daily inspection + flight inspection". Improve the adverse reaction, event monitoring system, the establishment of adverse reaction, event monitoring information notification mechanism, timely and effective measures to control risks.
(d) Strengthen the main responsibility. Strictly enforce the entry conditions of medical institutions, the implementation of the legal representative of the commitment system. Designated medical institutions to strengthen the procurement of drugs and medical equipment, import, use, storage, maintenance, ethical review, informed consent of patients, adverse event reporting, product recall, damage compensation management. Drug and medical equipment business enterprises to strengthen the procurement, import, storage and distribution management. Medical institutions applying for clinical urgency of imported drugs and medical equipment, must be signed by the legal representative of the commitment to declare the information is true, to ensure that the drugs and medical equipment in the use of the medical institutions, the risk of the use of imported drugs and medical equipment is fully responsible.
(E) Improve the relief system. Designated medical institutions and patients to sign an informed consent, clear dispute resolution, drawing on the Hong Kong and Macao to deal with the working model of medical accidents, with reference to the international insurance compensation mechanism, to protect the legitimate rights and interests of patients in the use of imported medicines and medical devices after the emergence of medical accidents. The drug regulatory authorities are responsible for the development of emergency plans, designated medical institutions are responsible for the development of emergency programs, increase the monitoring of public opinion, rapid and effective verification of accidents, disposal and other work.
