Notice of the State Administration of Market Supervision and other departments on the issuance of the "Guangdong-Hong Kong-Macao Greater Bay Area Drug and Medical Device Regulatory Innovation and Development Work Plan" State City Drug Administration [202

The People's Government of Guangdong Province:

The "Guangdong-Hong Kong-Macao Greater Bay Area Pharmaceutical and Medical Device Regulatory Innovation and Development Work Plan" (hereinafter referred to as the "Plan") has been approved by the State Council and is now issued to you.

Please your province earnestly implement the "four strictest" requirements and steadily advance the Guangdong-Hong Kong-Macao Greater Bay Area Regarding work related to the innovation and development of drug and medical device supervision and development in the district, step up efforts to formulate relevant supporting systems for the "Plan", implement supervision responsibilities, strengthen main responsibilities, do a good job in risk management and control, adhere to the bottom line of safety, and earnestly safeguard the safety of people's medical equipment

General Administration of Market Supervision, National Food and Drug Administration, National Development and Reform Commission, Ministry of Commerce, National Health Commission, General Administration of Customs, State Council, Hong Kong and Macao Affairs Office, State Administration of Traditional Chinese Medicine

September 29, 2020

In order to implement the "Guangdong-Hong Kong-Macao Greater Bay Area Development Plan Outline", promote the innovative development of drug and medical device supervision in the Guangdong-Hong Kong-Macao Greater Bay Area, explore the establishment of a new interactive and mutually beneficial drug and medical device cooperation model, and improve the level of modernization of the regulatory system and capabilities, this plan is formulated
.

1.

General requirements

(1) Guiding ideology
.

Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly implement General Secretary Jinping’s important instructions on the construction of the Guangdong-Hong Kong-Macao Greater Bay Area and the "four strictest" requirements, and adhere to the new development concept in accordance with the decisions and deployment of the Party Central Committee and the State Council , In-depth advance the reform of “delegation, regulation and service”, innovate drug and medical device supervision methods, integrate regulatory resources, promote the integrated development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area, better meet the needs of residents in the Guangdong-Hong Kong-Macao Greater Bay Area for medication and equipment, and ensure drug use Safe use of machinery to create a healthy Bay Area with innovation and vitality
.

(2) Basic principles
.

Adhere to "One Country, Two Systems" and act in accordance with the law
.

Integrate the maintenance of the national drug and medical device regulatory system and respect for the differences in regulatory mechanisms between Hong Kong and Macau, promote the docking of regulatory mechanisms between Guangdong, Hong Kong and Macau, promote the innovative development of drug and medical devices, and achieve the common development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area

Insist on shared development and improve people's livelihood
.

Adhere to the people-centered development concept, focus on the needs of residents in the Guangdong-Hong Kong-Macao Greater Bay Area, and continue to provide high-quality pharmaceutical and medical devices and services through innovative drug and medical device supervision methods, so that the residents of the Guangdong-Hong Kong-Macao Greater Bay Area have a sense of happiness, happiness and safety The feeling is more fulfilling, more secure, and more sustainable

Adhere to step-by-step implementation and pilot projects first
.

In response to the demand for imported medicines and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area, in order to strengthen supervision and ensure safety, we adhere to the step-by-step implementation.
We will initially set up pilot projects in some more mature places and medical institutions, and expand to Guangdong after obtaining reproducible and marketable experience.

(3) The overall goal
.

By 2022, the system and mechanism for local medical institutions in the Guangdong-Hong Kong-Macao Greater Bay Area to use Hong Kong and Macau-listed drugs and medical devices will be basically established, and the designated medical institutions in the Guangdong-Hong Kong-Macao Greater Bay Area will basically have the conditions to provide high-level medical equipment for Hong Kong and Macau; build Guangdong, Hong Kong and Macau The "soft interconnection" mechanism for the R&D, production, circulation and use of pharmaceuticals and medical devices in the Greater Bay Area and Hong Kong and Macao regions promotes the integrated development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area, and actively and steadily carries out the review and approval of Chinese patent medicines for external use in Hong Kong and Macao, and Hong Kong and Macao medicines and medical devices.
Pilot work such as local production in the Greater Bay Area; establish a national pharmaceutical and medical device technical support organization to promote the rapid and healthy development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area; rely on the international location advantages of the Guangdong-Hong Kong-Macao Greater Bay Area to promote the standardization, modernization, and modernization of traditional Chinese medicine.
Internationalization
.

By 2035, establish a complete Guangdong-Hong Kong-Macao Greater Bay Area drug and medical device supervision and coordination mechanism to provide convenient drug and medical device products and services for residents in Hong Kong, Macau and the Greater Bay Area; build a high-level technological innovation platform for the Guangdong-Hong Kong-Macao Greater Bay Area pharmaceutical industry , To realize the deep integration of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area and the upgrading of the pharmaceutical and medical device manufacturing industry, and build a national pharmaceutical industry innovation and development demonstration zone and a world-class bay area that is livable, business and travel
.

2.
Key tasks

(1) The use of drugs urgently needed for clinical use in designated medical institutions in 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area that have been marketed in Hong Kong and Macao shall be approved by the State Council of the People’s Government of Guangdong Province instead of being approved by the State Council
.

One is the scope of implementation
.

Regarding the scope of designated medical institutions

The second is the implementation procedure
.

Regarding import approval

(2) In the 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area, the implementation of the second paragraph of Article 11 of the Regulations on the Supervision and Administration of Medical Devices shall be suspended.
The designated medical institutions operating in the region are in urgent need of clinical use, and Hong Kong and Macao public hospitals have been purchased and used and have clinical applications Advanced medical devices are approved by the Guangdong Provincial Government
.

The first is to suspend the implementation of legal provisions
.

Temporarily adjust the second paragraph of Article 11 of the "Regulations on the Supervision and Administration of Medical Devices", "For overseas manufacturers that export Class II and Class III medical devices to China, their representative offices in China or designated As an agent, the enterprise legal person submits the registration application materials and the certification documents of the competent authority of the country (region) where the registration applicant is located to allow the medical device to be marketed to the Food and Drug Administration of the State Council

The second is the scope of implementation
.

Regarding the scope of designated medical institutions
.
Hong Kong and Macao medical and health service providers are established in 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area in the form of sole proprietorship, joint venture or cooperation, and are medical institutions that have been reviewed and determined by the Guangdong Provincial Health Commission
.
Adhere to the step-by-step implementation, take the Shenzhen Hospital of the University of Hong Kong as a pilot project, and gradually expand to other designated medical institutions that meet the requirements after obtaining reproducible and extendable experience
.
The relevant approval conditions and procedures are formulated by the Guangdong Provincial Health Commission
.
Regarding the scope of the imported medical device catalog
.
Hong Kong and Macao public hospitals have purchased and used medical devices that are urgently needed for clinical use and have advanced clinical applications.
The Guangdong Provincial Health Commission and the Food and Drug Administration in conjunction with the Hong Kong and Macao health authorities determine the imported medical device catalogue according to clinical needs, and implement dynamic adjustments
.

The third is the implementation procedure
.
Regarding import approval
.
The designated medical institution submits an application for the use of equipment, and the Guangdong Provincial Health Commission evaluates the clinical needs and issues an audit opinion.
The evaluation content includes whether the medical device to be imported is urgently needed for clinical use and has no other treatment methods, and whether the products currently on the market in China can achieve the same treatment effect, the ability to use equipment and other medical institutions
.
The Guangdong Provincial Food and Drug Administration evaluates the advanced nature of clinical applications, supports and issues import approval opinions for medical devices that are not of the same type approved for marketing in China
.
The Department of Commerce of Guangdong Province issues import review opinions on medical devices that are large-scale medical equipment in accordance with relevant regulations
.
Regarding customs clearance management
.
Designated medical institutions shall apply for the import declaration of medical devices according to the approval opinions of the Guangdong Provincial Food and Drug Administration (medical devices belonging to large-scale medical equipment shall also provide the import review opinions issued by the Guangdong Provincial Department of Commerce), and the Guangdong Customs shall verify and release them in accordance with regulations
.
Designated medical institutions shall entrust medical device operating companies to purchase, import and distribute medical devices in accordance with regulations
.

(3) Speed ​​up the construction of the Dawan District Center for Drug and Medical Device Evaluation and Inspection of the State Food and Drug Administration
.
As the dispatched agency of the Drug and Medical Device Review Center of the State Food and Drug Administration, the Greater Bay Area Center is mainly responsible for assisting the drug and medical device review agency of the State Food and Drug Administration to carry out pre-review communication and guidance and related inspections, and establish review Convenient mechanism for review and approval
.

(4) Support the development of the Chinese medicine industry in the Hengqin Guangdong-Macao Cooperation Chinese Medicine Science and Technology Industrial Park
.
One is to simplify the registration and approval process of proprietary Chinese medicines for external use
.
The State Food and Drug Administration has entrusted the Guangdong Provincial Food and Drug Administration to review and approve traditional Chinese patent medicines for external use that have been listed in Hong Kong and Macau
.
The second is to promote innovative research and development of traditional Chinese medicine products
.
Support the establishment of a traditional Chinese medicine product innovation incubation center in the Hengqin Guangdong-Macao Cooperation Traditional Chinese Medicine Technology Industrial Park, encourage traditional Chinese medical institutions to develop medical preparations in the industrial park, and encourage the research and development of traditional Chinese medical equipment in the industrial park
.
The third is to strengthen research on Chinese medicine policies and technologies
.
The Guangdong Provincial Food and Drug Administration, the Southern Institute of Pharmaceutical Economics of the State Food and Drug Administration, and the Hengqin Guangdong-Macao Cooperation Traditional Chinese Medicine Science and Technology Industrial Park jointly carry out policy and technical research on Chinese medicine standards and international exchange strategies, and establish Chinese medicine policy and technical research, Communication and dissemination platform to provide advice and suggestions for the improvement of the TCM policy system, promote the development of TCM, and promote the standardization, modernization and internationalization of TCM
.

(5) In the Guangdong-Hong Kong-Macao Greater Bay Area, reform the system of drug marketing license holders and medical device registrants
.
If the drug marketing license holder or medical device registrant is a Hong Kong or Macao enterprise, the Guangdong-Hong Kong-Macao Greater Bay Area enterprise legal person shall be appointed to perform the duties of the drug marketing license holder or medical device registrant, and the relevant Hong Kong and Macao enterprise shall be jointly and severally liable
.
Support Hong Kong and Macao drug marketing license holders and medical device registrants to produce drugs and medical devices held by eligible enterprises in 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area
.

(6) Establish a drug import port in Zhongshan City
.
According to the procedures, the establishment of an additional drug import port in Zhongshan City, Guangdong Province was declared, and the Zhongshan Laboratory of the Guangdong Drug Inspection Institute was used as the port drug inspection office in the evaluation and demonstration
.

3.
Safeguard Measures

(1) Establish a coordination mechanism
.
The State Administration for Market Regulation and the State Food and Drug Administration coordinate 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, and the State Administration of Traditional Chinese Medicine to coordinate and promote the implementation of related work
.
The People's Government of Guangdong Province takes the lead in establishing a coordination mechanism within Guangdong Province and with the governments of Hong Kong and Macao Special Administrative Regions, and is specifically responsible for implementation
.
The State Food and Drug Administration instructed the Guangdong Provincial Food and Drug Administration to establish a drug regulatory coordination mechanism in Guangdong, Hong Kong and Macao with Hong Kong and Macao drug regulatory agencies, researched and determined important issues for collaboration, regularly notified the regulatory status, and dynamically adjusted the list and scope of permitted drugs and medical devices
.

(2) Improve the supporting system
.
The Guangdong Provincial Food and Drug Administration, in conjunction with relevant parties, sorted out the list of supporting systems for drug and medical device innovation supervision, and formulated the supervision of the procurement, import, customs clearance, storage, distribution, and use of designated medical institutions and drugs and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area according to their functions.
Supporting systems and management methods, clarify the identification conditions of designated medical institutions, standardize the import procedures and use conditions of clinically urgently needed drugs and medical devices, refine storage, maintenance, and management requirements, clarify adverse reactions, adverse event monitoring, and emergency response
.
Measures involving the mainland's separate opening up to Hong Kong and Macau will be implemented under the framework of the Mainland, Hong Kong and Macau "A Closer Economic Partnership Arrangement" (CEPA)
.

(3) Implement supervision responsibility
.
The relevant functional departments of Guangdong Province strictly review and approve in accordance with the proposed supporting system to ensure that the application conditions, application materials, import customs clearance process and use management are unchanged, and the approval standards are not lowered to prevent the management of urgently needed imported drugs and medical devices from getting out of control
.
Accelerate the construction of a clinical information platform for the supervision of imported drugs and medical devices that are urgently needed, and establish a traceability system covering the entire process management of procurement, import, customs clearance, storage, distribution, and use, so as to achieve traceability, traceability, risk control, and accountability of drugs and medical devices.
Research
.
Strengthen daily supervision and inspection, explore the implementation of hierarchical and classified supervision, "daily inspection + unannounced inspection" and other measures
.
Improve the adverse reaction and event monitoring system, establish an adverse reaction and event monitoring information notification mechanism, and take effective measures to control risks in a timely manner
.

(4) Strengthen the main responsibility
.
Strictly implement the access conditions for medical institutions and implement the legal representative commitment system
.
Designated medical institutions to strengthen medicines procurement of medical equipment, import, use, storage, maintenance, ethical review, informed consent of patients, adverse event reporting, product recalls, damages and other management
.
Pharmaceutical and medical device operating companies strengthen the management of procurement, import, storage and distribution
.
Medical institutions that urgently need to import drugs and medical devices for clinical use must sign a letter of commitment by their legal representative, promising that the declared information is true, ensuring that the drugs and medical devices are used in the medical institution, and taking full responsibility for the risks of the imported drugs and medical devices
.

(5) Improve the relief system
.
The designated medical institution signs an informed consent form with the patient, clarifies the way of dispute resolution, draws on the work model of Hong Kong and Macau in handling medical accidents, and refers to the internationally accepted insurance compensation mechanism to protect the legal rights and interests of patients in the event of a medical accident after using imported medicines and medical devices
.
The drug regulatory department is responsible for formulating emergency plans, designated medical institutions are responsible for formulating emergency plans, increasing public opinion monitoring, and quickly and effectively doing accident verification and handling
.