(Policy Address 2023) Govt sets up preparatory office for establishment of local medicine regulator

Chief Executive John Lee Ka-chiu said the government will set up a preparatory office for the Hong Kong Centre for Medical Products Regulation (CMPR) to study the potential restructuring and strengthening of the current regulatory and approval regimes for medicine, medical devices and medical technology. 

The office will also put forward proposals and steps for the establishment of the CMPR which will be a step towards the transition of the “primary evaluation” approach in approving applications for registration of pharmaceutical products, and explore the upgrading of the CMPR as a standalone statutory body in the long run. 

“This will help accelerate the launching of new drugs and medical devices onto the market, and foster the development of R&D and testing of medical products and related industries,” Lee said. 

Lee continued that the government will pursue Hong Kong’s accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an observer to familiarize itself with and promote the latest development of drug regulation. 

The move also paves the way for developing Hong Kong into an internationally recognized regulatory authority for drugs and medical devices in the long run. 

The government will establish the Greater Bay Area International Clinical Trial Institute in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone next year to provide a one-stop clinical trial support platform for medical research institutions. 

The Institute will co-ordinate clinical trial resources in the public and private healthcare sectors in Hong Kong, including researchers, supporting services, data banks, sample banks, laboratories, etc. 

Hong Kong will also promote clinical research and trials under the Hospital Authority and establish the new “1+” mechanism to expedite the approval of new drugs.