Policy Address

  1. establish the Greater Bay Area International Clinical Trial Institute – We 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. We will discuss with the Shenzhen Municipal Government regarding a cooperation framework, with a view to achieving coordinated development of the Hong Kong and Shenzhen Parks. We will also explore cooperation with the clinical trial networks in the Mainland, in particular the GBA, through the Institute, and co-ordinate clinical trial work between the two places to comply with national and international standards;

  2. promote clinical research and trials under the HA – The HA will establish the Cluster Clinical Research Support Office in 2024-25. The office will provide advisory and support services for frontline staff, introduce additional measures to encourage medical teams to participate in clinical researches and trials, expedite the process of ethics review of clinical research, and strengthen the systems and mechanisms for supporting clinical research and data sharing; and

  3. establish the new "1+" mechanism to expedite the approval of new drugs – To accelerate patients' access to new chemical or biological entities (NCEs) and promote the development of clinical trials and research and development of drug in Hong Kong, we will enhance the existing drug regulatory regime by establishing the new "1+" mechanism this year. Under this mechanism, pharmaceutical products containing NCEs for life-threatening or severely-debilitating diseases with local clinical data will be allowed to register conditionally with only one certificate of pharmaceutical product (instead of two under the prevailing arrangement) issued by reference drug regulatory authorities (e.g. the National Medical Products Administration).