25 November 2020
The State Administration for Market Regulation and other departments have issued the work plan for regulatory innovation and development of pharmaceutical and medical device in the Guangdong-Hong Kong-Macao Greater Bay Area ("GBA") on 25 November 2020. The work plan is formulated to implement the outline development plan for the GBA, promote the innovative development of supervision of drug and medical device in the GBA, explore the establishment of a new interactive and mutually beneficial drug and medical device cooperation model, and improve the level of modernisation of the regulatory system and capabilities. The plan lists out 6 key tasks and 5 safeguard measures. The 6 key tasks include (1) changing the approval authority from the State Council to the People's Government of Guangdong Province for the use of drugs that are marketed in Hong Kong and Macao and urgently needed for clinical use in designated medical institutions operating in 9 cities in the GBA; (2) suspending the implementation of Article 11 of Paragraph 2 of the regulations on the supervision and administration of medical devices in 9 cities in the GBA, and requesting designated medical institutions operating in the region that shall use medical devices that are in urgent clinical need, have been purchased and used by public hospitals in Hong Kong and Macao and have advanced clinical application, to obtain approval from Guangdong Provincial Government; (3) accelerating the review process by the National Medical Products Administration in the construction of the GBA sub-centre for drug and medical device evaluation and inspection; (4) encouraging the development of traditional Chinese medicine in the Traditional Chinese Medicine Science and Technology Industrial Park of Co-operation between Guangdong and Macao in Hengqin; (5) reforming the system of drug marketing license holders and medical device registrants in the GBA; and (6) establishing a drug import port in Zhongshan. The 5 safeguard measures include establishing a coordination mechanism, improving supporting systems, implementing supervision responsibilities, strengthening subject accountabilities and improving remedy systems.