Based on the legislation of "small incision" service for medication and medical equipment "for the people's livelihood" - Interpretation of the "Regulations on the Management of Imported Hong Kong and Macao Drugs and Medical Equipment in Nine Mainland Cities of Guangdong Guangdong Hong Kong Macao Greater Bay Area"
Date：Aug 01,2024 Information source：Internet
In order to implement the "Outline of the Development Plan for the Guangdong Hong Kong Macao Greater Bay Area" (hereinafter referred to as the "Outline"), promote the implementation of the "Hong Kong Macao Drug and Equipment Connect" policy, ensure the safety of medication and equipment for residents in the Guangdong Hong Kong Macao Greater Bay Area, and meet their needs for medication and equipment, the Standing Committee of the Guangdong Provincial People''s Congress approved the "Regulations on the Management of Imported Hong Kong Macao Drugs and Medical Devices in Nine Mainland Cities of the Guangdong Hong Kong Macao Greater Bay Area" (hereinafter referred to as the "Regulations") on July 31, 2024, which will come into effect on December 1, 2024. Under the framework of relevant national laws and regulations, the Regulation, based on national authorization and combined with the actual situation of our province, adopts a "small incision" legislative approach to assist in the innovative development of drug and medical device supervision in the Guangdong Hong Kong Macao Greater Bay Area. It is of great significance to promote the integration and docking of high-quality medical resources in the Guangdong Hong Kong Macao Greater Bay Area, promote the high-level development of the Healthy Bay Area, and further enhance people''s well-being.
1、 Background of the Introduction of the Regulations
（1） It is a specific measure to implement the major national strategic deployment. In February 2019, the Central Committee of the Communist Party of China and the State Council issued the "Outline", which clearly requires close cooperation with Hong Kong and Macao in medical and health care, supports Hong Kong and Macao medical and health service providers to set up medical institutions in the nine cities of the Pearl River Delta in accordance with regulations through sole proprietorship, joint venture or cooperation, and shapes a healthy bay area. In September 2020, with the approval of the State Council, the State Administration for Market Regulation and eight other ministries issued the "Work Plan for Innovative Development of Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area" (hereinafter referred to as the "Plan"), granting Guangdong the approval authority for designated medical institutions in nine cities in the Guangdong Hong Kong Macao Greater Bay Area to import and use urgently needed drugs and medical devices from Hong Kong and Macao.
（2） It is an objective demand to meet the medication and equipment needs of residents in the Guangdong Hong Kong Macao Greater Bay Area. Since the implementation of the "Hong Kong Macau Medical Device Pass" policy, as of June 2024, a total of 19 designated medical institutions have been approved in this province. The variety of "Hong Kong Macau Medical Device Pass" has been expanded to 67 (including 34 drugs and 33 medical equipment), benefiting more than 7000 patients and effectively meeting the urgent clinical needs of the people for medical devices. However, in the implementation process of the "Hong Kong Macau Medical Device Connect" policy, there are still some problems to be faced. For example, the main responsibility is not clear, the cooperation mechanism is not smooth, the approval process is not perfect, and the regulatory measures are not sound. Some medical institutions have low enthusiasm for participating in the "Hong Kong Macau Medical Device Connect", and the burden on patients is high, resulting in low accessibility. In order to better meet the medication and equipment needs of residents in the Guangdong Hong Kong Macao Greater Bay Area, it is urgent to comprehensively organize the practical problems in the implementation process, summarize work experience, and ensure the implementation of the "Hong Kong Macao Drug and Equipment Connect" policy through legislation.
（3） It is an inevitable requirement for close cooperation in medical and health care with Hong Kong and Macao. The Outline proposes to achieve high-level market interconnectivity, efficient and convenient flow of various resource elements, and establish a dynamic and internationally competitive first-class bay area and world-class urban agglomeration. Rule linkage is a powerful guarantee for achieving high-level market interconnectivity and efficient and convenient flow of various resource elements in the Greater Bay Area, and is an inevitable requirement for achieving integrated development of the Greater Bay Area. In order to further strengthen cooperation with Hong Kong and Macao in the field of medical and health care, and enhance the connection in the regulatory rules of drugs and medical equipment, it is necessary to play a good role in legislative guidance, promotion, standardization, and protection.
2、 The significance of the Regulation
（1） Using legal means to solve the difficulties, pain points, and blockages in the urgent need for drug and equipment management in Hong Kong and Macau
The Regulations systematically organize the difficulties, pain points, and obstacles encountered by our province since the implementation of the "Hong Kong Macao Drug and Device Connect" policy, strengthen the coordination and cooperation of drug supervision and management, health, medical security and other departments, construct a full process supervision mechanism covering the application, procurement, import, distribution, and use of urgently needed Hong Kong and Macao drugs and devices, optimize the management system of the urgently needed Hong Kong and Macao drug and device catalog, simplify the review procedures, accelerate the review speed, and turn "people waiting for drugs" into "drugs waiting for people".
（2） Providing institutional support for the effective implementation of the "Hong Kong Macau Drug and Equipment Connect" policy through the power of the rule of law
The Regulation implements the overall requirements of the Outline for close cooperation with Hong Kong and Macao in medical and health care, and shaping a healthy bay area. It transforms the measures and requirements clearly stated in the Plan, such as the scope and procedures of implementation, strengthening main responsibilities, implementing regulatory requirements, and establishing cooperation mechanisms, into local regulations and provisions, further implementing and refining national work requirements, and providing institutional support for further promoting the implementation of the "Hong Kong Macao Drug and Device Connect" policy and promoting the urgent need for innovation in Hong Kong and Macao drug and device regulation.
（3） Using the rule of law to promote high-level development of the Healthy Bay Area
The integration and acceleration of the construction of the Guangdong Hong Kong Macao Greater Bay Area, as well as closer cooperation in areas such as healthcare and people''s livelihoods, have put forward new expectations and requirements for promoting higher levels of development in the Healthy Bay Area. The promulgation of the Regulation will play a fundamental, stable and long-term role in ensuring the rule of law, effectively promoting the integrated development of the pharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area, and providing strong legal protection for the construction of a more dynamic and innovative healthy bay area.
3、 Main content of the Regulation
The Regulation adheres to the principle of serving the people''s livelihood through "small incisions" and consists of 30 articles, which are not divided into chapters. The main contents are as follows:
（1） Adhere to the principle of putting the people first and ensure the safety of residents'' medication and equipment use
The safety of drugs and medical equipment is closely related to the physical health and life safety of the people, and it is also a practical interest issue of concern to the people and all sectors of society. The Regulations adhere to the principle of putting the people and their lives first, firmly establish risk awareness, uphold safety bottom line, and effectively safeguard the safety of people''s medication and equipment use.
One is to strictly apply the scope. Implement the national authorization regulations, clarify the scope of application of the regulations in Article 2, closely follow the key tasks of the Plan, and define the concept of urgently needed Hong Kong and Macao drugs and equipment. At the same time, in order to ensure the legal and regulatory management and use of urgently needed Hong Kong and Macau medical devices, it is emphasized that the application, procurement, import, distribution, use, and supervision of urgently needed Hong Kong and Macau medical devices should not only comply with the provisions of this regulation, but also comply with other relevant laws and regulations on drug and medical device management.
The second is to standardize the procurement and distribution management of urgently needed drugs and equipment in Hong Kong and Macau. Article 11 stipulates that pharmaceutical and medical equipment operating enterprises engaged in the procurement, import, and distribution of urgently needed Hong Kong and Macao pharmaceutical and medical equipment shall have the qualifications for pharmaceutical and medical equipment operation and import and export operation, possess corresponding modern logistics conditions and distribution capabilities, and be able to trace the entire process of urgently needed Hong Kong and Macao pharmaceutical and medical equipment. Article 12 stipulates that pharmaceutical and medical equipment operating enterprises should strengthen their management of business quality and safety, ensuring that the quality of urgently needed Hong Kong and Macao pharmaceutical and medical equipment purchased is consistent with the drugs and medical equipment used in Hong Kong and Macao markets.
The third is to standardize the management of the use of urgently needed drugs and equipment in Hong Kong and Macau. Article 14: Strictly designate the main responsibility of medical institutions, stipulate that designated medical institutions should strengthen their main responsibility, implement a legal representative commitment system, establish and improve relevant management systems, and strengthen the training of medical personnel. Article 15: Refine the management requirements for the use of medical devices, and stipulate that designated medical institutions should ensure the reasonable use of urgently needed Hong Kong and Macao medical devices in accordance with the applicable scope and corresponding clinical technical specifications. Before using urgently needed Hong Kong and Macao medical devices, informed consent should be signed with patients or their families, and relevant medical history and data should be properly kept. Article 16: Strengthen risk control in the use process, clarify that designated medical institutions should develop and improve safety prevention measures and risk monitoring and disposal plans, and dispose of them as required.
The fourth is to establish a system for urgently needed Hong Kong and Macao drugs and equipment vigilance, recall, traceability, etc. Article 17 stipulates that the Provincial Drug Administration shall, in conjunction with the Provincial Health Commission, formulate and improve emergency plans for the safety risks of urgently needed Hong Kong and Macao drugs and equipment, and properly handle drug and equipment safety risks. Pharmaceutical and medical equipment operating enterprises and designated medical institutions should establish a monitoring and reporting management system for adverse reactions and events of urgently needed Hong Kong and Macao pharmaceutical and medical equipment. Article 18 stipulates that pharmaceutical and medical device operating enterprises and designated medical institutions shall actively cooperate with relevant parties to fulfill their recall obligations, and immediately stop using and distributing those that need to be discontinued; For those who have evidence to prove that urgently needed Hong Kong and Macau medical devices may pose risks to human health and safety and should be recalled voluntarily but have not been recalled, the provincial drug supervision and management department shall order the medical device operating enterprises and designated medical institutions to promptly recall urgently needed Hong Kong and Macau medical devices. In order to achieve traceability of the source, destination, risk control, and accountability of urgently needed Hong Kong and Macao medical devices, Article 19 stipulates the establishment of a traceability system covering the entire process management, the implementation of a unique identification system for urgently needed Hong Kong and Macao medical devices, and the requirement for medical device operating enterprises and designated medical institutions to establish a procurement inspection system, and to keep relevant proof documents, transaction receipts, procurement, distribution, and acceptance records of urgently needed Hong Kong and Macao medical devices in accordance with relevant national regulations.
Fifth, clarify departmental regulatory measures. Article 25 stipulates that the drug regulatory authorities of the nine cities in mainland China shall strengthen supervision and inspection of designated medical institutions, explore graded and classified supervision, and may, if necessary, conduct extended inspections of pharmaceutical and medical equipment operating enterprises and related enterprises. Article 26 stipulates that for urgently needed drugs and equipment from Hong Kong and Macau that cause harm to the human body or have evidence of potential harm to human health, the provincial drug regulatory department may take control measures such as ordering the suspension of imports and use. Article 27: If pharmaceutical and medical equipment operating enterprises and designated medical institutions fail to establish and implement an urgent inspection and traceability system for the purchase of drugs and medical equipment from Hong Kong and Macao, the provincial drug supervision and management department and the health authority shall take measures such as warnings, agreements, and orders for correction in accordance with their respective responsibilities. Article 28: The mechanism for removing designated medical institutions from the list has been improved.
（2） Ensure the smooth implementation of the "Hong Kong Macau Medical Device Connect" policy to meet the needs of residents for medication and medical devices
The "Hong Kong Macau Medical Device Connect" policy has opened up a channel for international advanced and innovative drugs to quickly enter clinical applications in mainland China, improving the convenience of medical treatment for Hong Kong and Macau residents who come to Guangdong for work and life, better meeting the medication and device needs of residents in the Guangdong Hong Kong Macau Greater Bay Area, and promoting the integrated development of the pharmaceutical industry in the Greater Bay Area. In order to promote the implementation and refinement of this policy, fully unleash the policy dividends, and benefit more residents, the "Regulations" focus on the application, procurement, import, distribution, use and other links, and take multiple measures to connect and smooth the entire chain management.
One is to clarify the conditions for designating medical institutions and the application and review procedures. Our province has implemented the reform policy of "Hong Kong Macau Medical Device Connect" and carried out the application work for designated medical institutions, accumulating certain experience and achievements. Based on the requirements of the "Plan" and the actual situation of our province, the "Regulations" further refine the application review procedures and related conditions in Article 6, promoting more standardized application for designated medical institutions.
The second is to clarify the urgent need for the implementation of catalog management for Hong Kong and Macao drugs and equipment. Article 7 stipulates that the provincial drug supervision and administration department and the provincial health authority shall formulate a list of urgently needed Hong Kong and Macao drugs and devices in accordance with relevant national regulations based on clinical needs and the market and use of drugs and devices. Article 8 stipulates that the provincial drug supervision and administration department shall, in conjunction with the provincial health authority, establish an expert database for urgently needed Hong Kong and Macao drugs and devices, organize experts to evaluate the clinical urgency and use risks of drugs to be included in the urgently needed Hong Kong and Macao drug and device catalog, as well as the clinical urgency, advancement, and use risks of medical devices.
The third is to optimize the import review and customs clearance management of urgently needed drugs and equipment from Hong Kong and Macau. In legislative investigations, an important issue of concern for designated medical institutions and others is the lengthy application review process, which affects import use. After active communication with relevant departments, Article 8 has compressed the review time limit for applying for the import and use of drugs and medical devices in the urgently needed Hong Kong and Macao drug and device catalog to "five plus five", and the review time limit for applying for the import and use of drugs and medical devices outside the urgently needed Hong Kong and Macao drug and device catalog to "ten plus ten". It has also been specifically stipulated that the provincial drug supervision and administration department and the provincial health department should simplify the review process and compress the review time limit through online acceptance, parallel review, and other methods. Article 13 stipulates that the import of urgently needed drugs and medical equipment from Hong Kong and Macao shall be handled in accordance with the relevant regulations on the import customs clearance management of drugs and medical equipment. The drug supervision and management department at the port location shall not conduct port inspections for urgently needed drugs and medical equipment from Hong Kong and Macao in accordance with relevant national regulations, and shall coordinate with relevant units such as customs, civil aviation, and railways to optimize the customs clearance procedures for urgently needed drugs and medical equipment from Hong Kong and Macao.
The fourth is to strengthen the disclosure of urgently needed Hong Kong and Macao pharmaceutical and equipment information. In order to facilitate residents'' use of medication and equipment, the Regulation strengthens the disclosure of relevant information and clarifies three "disclosures to the society". Specifically, in order to facilitate the public''s understanding of which medical institutions can apply for the import and use of urgently needed drugs and equipment from Hong Kong and Macao, Article 6 stipulates that the provincial health authority, in conjunction with the provincial drug supervision and management department, shall publish a list of designated medical institutions to the public. In order to facilitate the public''s understanding of which urgently needed Hong Kong and Macao medical devices can be applied for import and use, Article 7 stipulates that the list of urgently needed Hong Kong and Macao medical devices should be dynamically adjusted and promptly announced to the society. When formulating and adjusting, opinions from relevant government departments, industry associations, medical institutions, medical device operating enterprises, and the general public should be heard. In order to facilitate the public''s understanding of which designated medical institutions have urgent needs for Hong Kong and Macao drugs and equipment that can be used, for designated medical institutions that apply for approval to import and use urgently needed Hong Kong and Macao drugs and equipment, Article 9 stipulates that the provincial drug supervision and administration department should regularly summarize the approved documents and promptly disclose to society the names of urgently needed Hong Kong and Macao drugs and equipment products, designated medical institutions for import and use, and other information on the approved documents.
The fifth is to encourage real-world research on urgently needed Hong Kong and Macau drugs and equipment. In recent years, the national drug supervision and management departments have introduced technical guidance principles and other related documents to promote real-world research. In order to further promote the high-quality development of the pharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area and support exploration and innovation, Article 23 encourages designated medical institutions to conduct real-world research on urgently needed Hong Kong and Macao drugs and devices in accordance with national technical guidance principles, and supports the application for registration and listing of urgently needed Hong Kong and Macao drugs and devices with good efficacy in mainland China.
Six is to take multiple measures to promote the use of imports. Article 24: Strengthen publicity and service guidance, support the construction of medical consortia, encourage Hong Kong and Macao medical personnel to practice in Guangdong for a short period of time, support regions such as Hengqin, Qianhai, and Nansha to strengthen the import and use of urgently needed Hong Kong and Macao drugs and equipment, support the optimization of medical institution assessment systems, and take a series of measures to further promote the implementation of the "Hong Kong Macao Drug and Equipment Connect" policy and facilitate the import and use of urgently needed Hong Kong and Macao drugs and equipment.
（3） Promote innovation in supervision methods and shape a healthy bay area with innovative vitality
In recent years, the connection between the Guangdong Hong Kong Macao Greater Bay Area has become increasingly close, and cross-border medical resource sharing and interconnection have accelerated. The construction of a healthy bay area has been continuously promoted, and the importance of innovative development in drug and medical device regulation in the Guangdong Hong Kong Macao Greater Bay Area has become more prominent. The Regulation implements the requirements of the Third Plenary Session of the 20th Central Committee of the Communist Party of China on innovating medical and health supervision methods, improving the mechanism for supporting the development of innovative drugs and medical devices, actively exploring and promoting the innovation of drug and medical device supervision methods, and enhancing the modernization level of the supervision system and capabilities.
One is to improve the supervision system. Article 3 stipulates that the people''s governments of provinces and nine cities in mainland China shall strengthen their leadership in the supervision and management of urgently needed drugs and medical devices in Hong Kong and Macao within their administrative regions, organize and coordinate the supervision and management of urgently needed drugs and medical devices in Hong Kong and Macao within their administrative regions, as well as emergency response work, and establish and improve a supervision and management mechanism and information sharing mechanism for close cooperation between the people''s governments of provinces and nine cities in mainland China and relevant departments. Article 4: Clarify the division of responsibilities among drug supervision and management, health, medical security and other departments, and clarify that development and reform, finance, commerce, market supervision and management, traditional Chinese medicine and other relevant departments, as well as customs and other relevant units, should do a good job in the urgent need for Hong Kong and Macao drug and equipment supervision and management within their respective responsibilities.
The second is to improve the cooperation mechanism among Guangdong, Hong Kong, and Macao. Article 5 stipulates that the provincial people''s government shall promote the establishment of a cooperation mechanism between Guangdong Province and Hong Kong and Macao, and stipulate that the provincial drug industry
1、 Background of the Introduction of the Regulations
（1） It is a specific measure to implement the major national strategic deployment. In February 2019, the Central Committee of the Communist Party of China and the State Council issued the "Outline", which clearly requires close cooperation with Hong Kong and Macao in medical and health care, supports Hong Kong and Macao medical and health service providers to set up medical institutions in the nine cities of the Pearl River Delta in accordance with regulations through sole proprietorship, joint venture or cooperation, and shapes a healthy bay area. In September 2020, with the approval of the State Council, the State Administration for Market Regulation and eight other ministries issued the "Work Plan for Innovative Development of Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area" (hereinafter referred to as the "Plan"), granting Guangdong the approval authority for designated medical institutions in nine cities in the Guangdong Hong Kong Macao Greater Bay Area to import and use urgently needed drugs and medical devices from Hong Kong and Macao.
（2） It is an objective demand to meet the medication and equipment needs of residents in the Guangdong Hong Kong Macao Greater Bay Area. Since the implementation of the "Hong Kong Macau Medical Device Pass" policy, as of June 2024, a total of 19 designated medical institutions have been approved in this province. The variety of "Hong Kong Macau Medical Device Pass" has been expanded to 67 (including 34 drugs and 33 medical equipment), benefiting more than 7000 patients and effectively meeting the urgent clinical needs of the people for medical devices. However, in the implementation process of the "Hong Kong Macau Medical Device Connect" policy, there are still some problems to be faced. For example, the main responsibility is not clear, the cooperation mechanism is not smooth, the approval process is not perfect, and the regulatory measures are not sound. Some medical institutions have low enthusiasm for participating in the "Hong Kong Macau Medical Device Connect", and the burden on patients is high, resulting in low accessibility. In order to better meet the medication and equipment needs of residents in the Guangdong Hong Kong Macao Greater Bay Area, it is urgent to comprehensively organize the practical problems in the implementation process, summarize work experience, and ensure the implementation of the "Hong Kong Macao Drug and Equipment Connect" policy through legislation.
（3） It is an inevitable requirement for close cooperation in medical and health care with Hong Kong and Macao. The Outline proposes to achieve high-level market interconnectivity, efficient and convenient flow of various resource elements, and establish a dynamic and internationally competitive first-class bay area and world-class urban agglomeration. Rule linkage is a powerful guarantee for achieving high-level market interconnectivity and efficient and convenient flow of various resource elements in the Greater Bay Area, and is an inevitable requirement for achieving integrated development of the Greater Bay Area. In order to further strengthen cooperation with Hong Kong and Macao in the field of medical and health care, and enhance the connection in the regulatory rules of drugs and medical equipment, it is necessary to play a good role in legislative guidance, promotion, standardization, and protection.
2、 The significance of the Regulation
（1） Using legal means to solve the difficulties, pain points, and blockages in the urgent need for drug and equipment management in Hong Kong and Macau
The Regulations systematically organize the difficulties, pain points, and obstacles encountered by our province since the implementation of the "Hong Kong Macao Drug and Device Connect" policy, strengthen the coordination and cooperation of drug supervision and management, health, medical security and other departments, construct a full process supervision mechanism covering the application, procurement, import, distribution, and use of urgently needed Hong Kong and Macao drugs and devices, optimize the management system of the urgently needed Hong Kong and Macao drug and device catalog, simplify the review procedures, accelerate the review speed, and turn "people waiting for drugs" into "drugs waiting for people".
（2） Providing institutional support for the effective implementation of the "Hong Kong Macau Drug and Equipment Connect" policy through the power of the rule of law
The Regulation implements the overall requirements of the Outline for close cooperation with Hong Kong and Macao in medical and health care, and shaping a healthy bay area. It transforms the measures and requirements clearly stated in the Plan, such as the scope and procedures of implementation, strengthening main responsibilities, implementing regulatory requirements, and establishing cooperation mechanisms, into local regulations and provisions, further implementing and refining national work requirements, and providing institutional support for further promoting the implementation of the "Hong Kong Macao Drug and Device Connect" policy and promoting the urgent need for innovation in Hong Kong and Macao drug and device regulation.
（3） Using the rule of law to promote high-level development of the Healthy Bay Area
The integration and acceleration of the construction of the Guangdong Hong Kong Macao Greater Bay Area, as well as closer cooperation in areas such as healthcare and people''s livelihoods, have put forward new expectations and requirements for promoting higher levels of development in the Healthy Bay Area. The promulgation of the Regulation will play a fundamental, stable and long-term role in ensuring the rule of law, effectively promoting the integrated development of the pharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area, and providing strong legal protection for the construction of a more dynamic and innovative healthy bay area.
3、 Main content of the Regulation
The Regulation adheres to the principle of serving the people''s livelihood through "small incisions" and consists of 30 articles, which are not divided into chapters. The main contents are as follows:
（1） Adhere to the principle of putting the people first and ensure the safety of residents'' medication and equipment use
The safety of drugs and medical equipment is closely related to the physical health and life safety of the people, and it is also a practical interest issue of concern to the people and all sectors of society. The Regulations adhere to the principle of putting the people and their lives first, firmly establish risk awareness, uphold safety bottom line, and effectively safeguard the safety of people''s medication and equipment use.
One is to strictly apply the scope. Implement the national authorization regulations, clarify the scope of application of the regulations in Article 2, closely follow the key tasks of the Plan, and define the concept of urgently needed Hong Kong and Macao drugs and equipment. At the same time, in order to ensure the legal and regulatory management and use of urgently needed Hong Kong and Macau medical devices, it is emphasized that the application, procurement, import, distribution, use, and supervision of urgently needed Hong Kong and Macau medical devices should not only comply with the provisions of this regulation, but also comply with other relevant laws and regulations on drug and medical device management.
The second is to standardize the procurement and distribution management of urgently needed drugs and equipment in Hong Kong and Macau. Article 11 stipulates that pharmaceutical and medical equipment operating enterprises engaged in the procurement, import, and distribution of urgently needed Hong Kong and Macao pharmaceutical and medical equipment shall have the qualifications for pharmaceutical and medical equipment operation and import and export operation, possess corresponding modern logistics conditions and distribution capabilities, and be able to trace the entire process of urgently needed Hong Kong and Macao pharmaceutical and medical equipment. Article 12 stipulates that pharmaceutical and medical equipment operating enterprises should strengthen their management of business quality and safety, ensuring that the quality of urgently needed Hong Kong and Macao pharmaceutical and medical equipment purchased is consistent with the drugs and medical equipment used in Hong Kong and Macao markets.
The third is to standardize the management of the use of urgently needed drugs and equipment in Hong Kong and Macau. Article 14: Strictly designate the main responsibility of medical institutions, stipulate that designated medical institutions should strengthen their main responsibility, implement a legal representative commitment system, establish and improve relevant management systems, and strengthen the training of medical personnel. Article 15: Refine the management requirements for the use of medical devices, and stipulate that designated medical institutions should ensure the reasonable use of urgently needed Hong Kong and Macao medical devices in accordance with the applicable scope and corresponding clinical technical specifications. Before using urgently needed Hong Kong and Macao medical devices, informed consent should be signed with patients or their families, and relevant medical history and data should be properly kept. Article 16: Strengthen risk control in the use process, clarify that designated medical institutions should develop and improve safety prevention measures and risk monitoring and disposal plans, and dispose of them as required.
The fourth is to establish a system for urgently needed Hong Kong and Macao drugs and equipment vigilance, recall, traceability, etc. Article 17 stipulates that the Provincial Drug Administration shall, in conjunction with the Provincial Health Commission, formulate and improve emergency plans for the safety risks of urgently needed Hong Kong and Macao drugs and equipment, and properly handle drug and equipment safety risks. Pharmaceutical and medical equipment operating enterprises and designated medical institutions should establish a monitoring and reporting management system for adverse reactions and events of urgently needed Hong Kong and Macao pharmaceutical and medical equipment. Article 18 stipulates that pharmaceutical and medical device operating enterprises and designated medical institutions shall actively cooperate with relevant parties to fulfill their recall obligations, and immediately stop using and distributing those that need to be discontinued; For those who have evidence to prove that urgently needed Hong Kong and Macau medical devices may pose risks to human health and safety and should be recalled voluntarily but have not been recalled, the provincial drug supervision and management department shall order the medical device operating enterprises and designated medical institutions to promptly recall urgently needed Hong Kong and Macau medical devices. In order to achieve traceability of the source, destination, risk control, and accountability of urgently needed Hong Kong and Macao medical devices, Article 19 stipulates the establishment of a traceability system covering the entire process management, the implementation of a unique identification system for urgently needed Hong Kong and Macao medical devices, and the requirement for medical device operating enterprises and designated medical institutions to establish a procurement inspection system, and to keep relevant proof documents, transaction receipts, procurement, distribution, and acceptance records of urgently needed Hong Kong and Macao medical devices in accordance with relevant national regulations.
Fifth, clarify departmental regulatory measures. Article 25 stipulates that the drug regulatory authorities of the nine cities in mainland China shall strengthen supervision and inspection of designated medical institutions, explore graded and classified supervision, and may, if necessary, conduct extended inspections of pharmaceutical and medical equipment operating enterprises and related enterprises. Article 26 stipulates that for urgently needed drugs and equipment from Hong Kong and Macau that cause harm to the human body or have evidence of potential harm to human health, the provincial drug regulatory department may take control measures such as ordering the suspension of imports and use. Article 27: If pharmaceutical and medical equipment operating enterprises and designated medical institutions fail to establish and implement an urgent inspection and traceability system for the purchase of drugs and medical equipment from Hong Kong and Macao, the provincial drug supervision and management department and the health authority shall take measures such as warnings, agreements, and orders for correction in accordance with their respective responsibilities. Article 28: The mechanism for removing designated medical institutions from the list has been improved.
（2） Ensure the smooth implementation of the "Hong Kong Macau Medical Device Connect" policy to meet the needs of residents for medication and medical devices
The "Hong Kong Macau Medical Device Connect" policy has opened up a channel for international advanced and innovative drugs to quickly enter clinical applications in mainland China, improving the convenience of medical treatment for Hong Kong and Macau residents who come to Guangdong for work and life, better meeting the medication and device needs of residents in the Guangdong Hong Kong Macau Greater Bay Area, and promoting the integrated development of the pharmaceutical industry in the Greater Bay Area. In order to promote the implementation and refinement of this policy, fully unleash the policy dividends, and benefit more residents, the "Regulations" focus on the application, procurement, import, distribution, use and other links, and take multiple measures to connect and smooth the entire chain management.
One is to clarify the conditions for designating medical institutions and the application and review procedures. Our province has implemented the reform policy of "Hong Kong Macau Medical Device Connect" and carried out the application work for designated medical institutions, accumulating certain experience and achievements. Based on the requirements of the "Plan" and the actual situation of our province, the "Regulations" further refine the application review procedures and related conditions in Article 6, promoting more standardized application for designated medical institutions.
The second is to clarify the urgent need for the implementation of catalog management for Hong Kong and Macao drugs and equipment. Article 7 stipulates that the provincial drug supervision and administration department and the provincial health authority shall formulate a list of urgently needed Hong Kong and Macao drugs and devices in accordance with relevant national regulations based on clinical needs and the market and use of drugs and devices. Article 8 stipulates that the provincial drug supervision and administration department shall, in conjunction with the provincial health authority, establish an expert database for urgently needed Hong Kong and Macao drugs and devices, organize experts to evaluate the clinical urgency and use risks of drugs to be included in the urgently needed Hong Kong and Macao drug and device catalog, as well as the clinical urgency, advancement, and use risks of medical devices.
The third is to optimize the import review and customs clearance management of urgently needed drugs and equipment from Hong Kong and Macau. In legislative investigations, an important issue of concern for designated medical institutions and others is the lengthy application review process, which affects import use. After active communication with relevant departments, Article 8 has compressed the review time limit for applying for the import and use of drugs and medical devices in the urgently needed Hong Kong and Macao drug and device catalog to "five plus five", and the review time limit for applying for the import and use of drugs and medical devices outside the urgently needed Hong Kong and Macao drug and device catalog to "ten plus ten". It has also been specifically stipulated that the provincial drug supervision and administration department and the provincial health department should simplify the review process and compress the review time limit through online acceptance, parallel review, and other methods. Article 13 stipulates that the import of urgently needed drugs and medical equipment from Hong Kong and Macao shall be handled in accordance with the relevant regulations on the import customs clearance management of drugs and medical equipment. The drug supervision and management department at the port location shall not conduct port inspections for urgently needed drugs and medical equipment from Hong Kong and Macao in accordance with relevant national regulations, and shall coordinate with relevant units such as customs, civil aviation, and railways to optimize the customs clearance procedures for urgently needed drugs and medical equipment from Hong Kong and Macao.
The fourth is to strengthen the disclosure of urgently needed Hong Kong and Macao pharmaceutical and equipment information. In order to facilitate residents'' use of medication and equipment, the Regulation strengthens the disclosure of relevant information and clarifies three "disclosures to the society". Specifically, in order to facilitate the public''s understanding of which medical institutions can apply for the import and use of urgently needed drugs and equipment from Hong Kong and Macao, Article 6 stipulates that the provincial health authority, in conjunction with the provincial drug supervision and management department, shall publish a list of designated medical institutions to the public. In order to facilitate the public''s understanding of which urgently needed Hong Kong and Macao medical devices can be applied for import and use, Article 7 stipulates that the list of urgently needed Hong Kong and Macao medical devices should be dynamically adjusted and promptly announced to the society. When formulating and adjusting, opinions from relevant government departments, industry associations, medical institutions, medical device operating enterprises, and the general public should be heard. In order to facilitate the public''s understanding of which designated medical institutions have urgent needs for Hong Kong and Macao drugs and equipment that can be used, for designated medical institutions that apply for approval to import and use urgently needed Hong Kong and Macao drugs and equipment, Article 9 stipulates that the provincial drug supervision and administration department should regularly summarize the approved documents and promptly disclose to society the names of urgently needed Hong Kong and Macao drugs and equipment products, designated medical institutions for import and use, and other information on the approved documents.
The fifth is to encourage real-world research on urgently needed Hong Kong and Macau drugs and equipment. In recent years, the national drug supervision and management departments have introduced technical guidance principles and other related documents to promote real-world research. In order to further promote the high-quality development of the pharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area and support exploration and innovation, Article 23 encourages designated medical institutions to conduct real-world research on urgently needed Hong Kong and Macao drugs and devices in accordance with national technical guidance principles, and supports the application for registration and listing of urgently needed Hong Kong and Macao drugs and devices with good efficacy in mainland China.
Six is to take multiple measures to promote the use of imports. Article 24: Strengthen publicity and service guidance, support the construction of medical consortia, encourage Hong Kong and Macao medical personnel to practice in Guangdong for a short period of time, support regions such as Hengqin, Qianhai, and Nansha to strengthen the import and use of urgently needed Hong Kong and Macao drugs and equipment, support the optimization of medical institution assessment systems, and take a series of measures to further promote the implementation of the "Hong Kong Macao Drug and Equipment Connect" policy and facilitate the import and use of urgently needed Hong Kong and Macao drugs and equipment.
（3） Promote innovation in supervision methods and shape a healthy bay area with innovative vitality
In recent years, the connection between the Guangdong Hong Kong Macao Greater Bay Area has become increasingly close, and cross-border medical resource sharing and interconnection have accelerated. The construction of a healthy bay area has been continuously promoted, and the importance of innovative development in drug and medical device regulation in the Guangdong Hong Kong Macao Greater Bay Area has become more prominent. The Regulation implements the requirements of the Third Plenary Session of the 20th Central Committee of the Communist Party of China on innovating medical and health supervision methods, improving the mechanism for supporting the development of innovative drugs and medical devices, actively exploring and promoting the innovation of drug and medical device supervision methods, and enhancing the modernization level of the supervision system and capabilities.
One is to improve the supervision system. Article 3 stipulates that the people''s governments of provinces and nine cities in mainland China shall strengthen their leadership in the supervision and management of urgently needed drugs and medical devices in Hong Kong and Macao within their administrative regions, organize and coordinate the supervision and management of urgently needed drugs and medical devices in Hong Kong and Macao within their administrative regions, as well as emergency response work, and establish and improve a supervision and management mechanism and information sharing mechanism for close cooperation between the people''s governments of provinces and nine cities in mainland China and relevant departments. Article 4: Clarify the division of responsibilities among drug supervision and management, health, medical security and other departments, and clarify that development and reform, finance, commerce, market supervision and management, traditional Chinese medicine and other relevant departments, as well as customs and other relevant units, should do a good job in the urgent need for Hong Kong and Macao drug and equipment supervision and management within their respective responsibilities.
The second is to improve the cooperation mechanism among Guangdong, Hong Kong, and Macao. Article 5 stipulates that the provincial people''s government shall promote the establishment of a cooperation mechanism between Guangdong Province and Hong Kong and Macao, and stipulate that the provincial drug industry