Forwarding of the Notice on Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the Guangdong-Hong Kong-Macao Greater Bay Area by the Provincial and Municipal Ministries and Commissions
To people's governments of Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen and Zhaoqing,
With the consent of the provincial people's government, the Notice on Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the Guangdong-Hong Kong-Macao Greater Bay Area (GSJY  No. 159) by the State Administration for Market Regulation is hereby forwarded to you, and relevant work is notified as follows:
Guangdong Administration for Market Regulation and Guangdong Medical Products Administration, together with Guangdong Provincial Development and Reform Commission (Greater Bay Area Office), Department of Finance of Guangdong Province, Department of Commerce of Guangdong Province, Health Commission of Guangdong Province, Guangdong Sub-administration of GACC, Hong Kong and Macao Affairs Office of the People's Government of Guangdong Province, and Traditional Chinese Medicine Bureau of Guangdong Province, coordinate and promote the implementation of relevant work.
Guangdong Medical Products Administration takes the lead in organizing Shenzhen Municipal People's Government and relevant departments to provide pilot work of using Hong Kong and Macao drugs and medical devices in the University of Hong Kong-Shenzhen Hospital. The pilot period will last until July 31, 2021. The administration is responsible for organizing the evaluation and selection of pilot drugs and medical devices, and implementing the examination and approval; it takes the lead in strengthening the construction of supporting systems together with relevant departments, sorting out the list of supporting systems, and formulating the whole process supervision supporting systems and management measures according to the functions. After the pilot work, Guangdong Medical Products Administration prepares and reports pilot work summary and work suggestions to the provincial government. The Health Commission of Guangdong Province is responsible for formulating the approval conditions and procedures for designated medical institutions, and formulating the review requirements and procedures for the clinical use of drugs and medical instruments in Hong Kong and Macao by designated medical institutions. Guangdong Provincial Development and Reform Commission (Greater Bay Area Office) strengthens service coordination and follow-up of policy implementation. According to the Mainland and Hong Kong Closer Economic Partnership Arrangement (CEPA), the Department of Finance of Guangdong Province organizes and collects the requirements for reducing import tariff proposed by designated medical institutions, forms tax rate adjustment opinions with customs departments and submits them to the Ministry of Finance for approval. Guangdong Sub-administration of GACC coordinates relevant customs in 9 mainland cities of Greater Bay Area to provide import customs clearance involved. The Hong Kong and Macao Affairs Office of the People's Government of Guangdong Province cooperates with Guangdong Medical Products Administration and the drug regulatory authorities in Hong Kong and Macao to establish a drug supervision and cooperation mechanism in Guangdong, Hong Kong and Macao.
The relevant municipal people's governments should attach great importance to it, organize and implement it in a timely manner, clarify the responsibilities of relevant departments, implement the supervision work, provide risk management and control, and keep the bottom line of regional and systematic safety risks. In case of any new situation and any new problem in pilot work, please report to Guangdong Medical Products Administration in time.
Guangdong Administration for Market Regulation