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Preparatory Office for the Hong Kong Centre for Medical Products Regulation

“The Chief Executive’s 2023 Policy Address” announced that the Government will leverage the medical strengths of the Hong Kong Special Administrative Region with the long-term objective of establishing an authority, i.e. the Hong Kong Centre for the Medical Products Regulation (CMPR), that registers drugs and medical devices (medical products) under the “primary evaluation” approach, i.e. to directly approve applications for registration of medical products in Hong Kong based on clinical trial data, without relying on registration approval from other drug regulatory authorities. This will help accelerate the clinical use of new drugs and medical devices, and foster the development of industries relating to the research and development and clinical trials of medical products, developing Hong Kong into an international health and medical innovative hub.

The Preparatory Office for the CMPR was set up under the Department of Health in June 2024. The specific work of the Preparatory Office includes:

• Comprehensively studying and planning a regulatory and approval regime for drugs and medical devices suitable for Hong Kong;
• Putting forward proposals and steps for the establishment of the CMPR;
• Conducting a review on the need for amending existing legislations to promote the development of medical products regulation; and
• Making recommendations to the Steering Committee on Health and Medical Innovation and Development (chaired by the Secretary of Health); as well as maintaining close communication with various stakeholders.