To further implement the Outline Development Plan for the Guangdong-Hong Kong-Macao Greater Bay Area, the State Administration for Market Regulation, the National Medical Products Administration, 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 National Administration of Traditional Chinese Medicine jointly issued the Work Plan for the Innovative Development of the Regulation of Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area (hereinafter referred to as the “Work Plan”) on September 29. The Work Plan thoroughly implements the spirit of General Secretary Xi Jinping’s important instructions on the building of the Guangdong-Hong Kong-Macao Greater Bay Area and the “Four Strictest (strictest standards, regulation, punishment and accountability)” requirements, adheres to new development concepts, explores the establishment of a new model of interactive and mutually beneficial cooperation in drugs and medical devices, and advances the innovative development of regulation of drugs and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area (hereinafter referred to as the “GBA”) to better meet the needs of the GBA residents for drugs and medical devices.
The Work Plan adheres to the principles of “One Country, Two Systems” and the rule of law, requires organically combining the upholding of the national drug and medical device regulatory system and respect for the differences from the regulatory mechanisms of Hong Kong and Macao to promote the coordination of the regulatory mechanisms of Guangdong, Hong Kong and Macao, and requires establishing a regulatory system covering the whole process management of procurement, import, customs clearance, storage, distribution and use between the nine mainland cities of the GBA and Hong Kong and Macao. The Work Plan establishes many innovative measures: 1. using urgently-needed drugs for clinic use, which are already marketed in Hong Kong and Macao, in designated medical institutions operated in nine mainland cities of the GBA, with the approver for such use to change from the National Medical Products Administration (“NMPA”) to the People’s Government of Guangdong Province as authorized by the State Council; 2. suspending the implementation of Paragraph 2 of Article 11 of the Regulations on the Supervision and Administration of Medical Devices in nine mainland cities of the GBA, and empowering the People’s Government of Guangdong Province to approve the use of urgently-needed medical devices for clinic use, which are already purchased and used by public hospitals in Hong Kong and Macao and which have advanced nature in clinical application, in designated medical institutions operated in the said region; 3. establishing the GBA sub-center of the NMPA for the evaluation and inspection of drugs and medical devices, to provide national-level technical support for the innovative development of the biological medicine industry in the GBA; 4. supporting the development of the traditional Chinese medicine industry in the Traditional Chinese Medicine Science and Technology Industrial Park of Co-operation between Guangdong and Macao in Hengqin; and 5. carrying out the reform of the system of drug marketing authorization holders and medical device registrants in the GBA. In addition, a new port permitted for drug import will be established in Zhongshan of Guangdong.
To strengthen regulation and ensure safety, the Work Plan requires step-by-step implementation, where it will first be piloted in medical institutions in places with mature conditions and, after the experience that can be replicated and promoted is obtained, be expanded to other areas and medical institutions in the GBA that meet the requirements.
The Work Plan adheres to the principles of “One Country, Two Systems” and the rule of law, requires organically combining the upholding of the national drug and medical device regulatory system and respect for the differences from the regulatory mechanisms of Hong Kong and Macao to promote the coordination of the regulatory mechanisms of Guangdong, Hong Kong and Macao, and requires establishing a regulatory system covering the whole process management of procurement, import, customs clearance, storage, distribution and use between the nine mainland cities of the GBA and Hong Kong and Macao. The Work Plan establishes many innovative measures: 1. using urgently-needed drugs for clinic use, which are already marketed in Hong Kong and Macao, in designated medical institutions operated in nine mainland cities of the GBA, with the approver for such use to change from the National Medical Products Administration (“NMPA”) to the People’s Government of Guangdong Province as authorized by the State Council; 2. suspending the implementation of Paragraph 2 of Article 11 of the Regulations on the Supervision and Administration of Medical Devices in nine mainland cities of the GBA, and empowering the People’s Government of Guangdong Province to approve the use of urgently-needed medical devices for clinic use, which are already purchased and used by public hospitals in Hong Kong and Macao and which have advanced nature in clinical application, in designated medical institutions operated in the said region; 3. establishing the GBA sub-center of the NMPA for the evaluation and inspection of drugs and medical devices, to provide national-level technical support for the innovative development of the biological medicine industry in the GBA; 4. supporting the development of the traditional Chinese medicine industry in the Traditional Chinese Medicine Science and Technology Industrial Park of Co-operation between Guangdong and Macao in Hengqin; and 5. carrying out the reform of the system of drug marketing authorization holders and medical device registrants in the GBA. In addition, a new port permitted for drug import will be established in Zhongshan of Guangdong.
To strengthen regulation and ensure safety, the Work Plan requires step-by-step implementation, where it will first be piloted in medical institutions in places with mature conditions and, after the experience that can be replicated and promoted is obtained, be expanded to other areas and medical institutions in the GBA that meet the requirements.