Co-authored by guest bloggers Alison Scott and Bianca Wu of Howse Williams. Not affiliated with Covington & Burling LLP.
In his 2023 Policy Address on October 25, 2023 (“Policy Address”), the Hong Kong Chief Executive officially proposed to establish a preparatory office for the Hong Kong Centre of Medical Products Regulation (“CMPR”). According to the Policy Address, the preparatory office and the CMPR would be a step toward establishing Hong Kong as a “home grown” drug approval authority with primary evaluation capacity, thereby fostering industry research and development and accelerating the launch of new drugs and medical devices in Hong Kong. It is envisaged under the Policy Address that these changes would drive Hong Kong as an international biomedical hub, making it eligible for membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Hong Kong’s current drug registration regime requires that at least one foreign approval be obtained in support of the registration of a drug (or a biosimilar). For drugs containing a new chemical or biological entity, two or more approvals are required from a list of 36 recognized countries. The Policy Address includes a proposed “1+” mechanism, which would shortcut this process by allowing drugs containing new chemical entities for life-threatening or severely debilitating diseases to be accepted with only one certificate of pharmaceutical product. It is anticipated that this change would cut the approval time for new drugs from 2 years to 7 months. Further efficiency would be gained by centralizing the review and approval authority under the CMPR, rather than relying on the current overlapping powers of the Drug Office, Pharmacy and Poisons Board, and the Legislative Council.
The Policy Address also calls for the establishment of the Great Bay Area International Clinical Trial Institute in the Hetao Collaboration Zone. The Institute will help facilitate clinical trials by providing a one‑stop clinical trial support platform for medical research institutions, collecting clinical trial resources in the public and private healthcare sectors in Hong Kong—including researchers, supporting services, data banks, sample banks, and laboratories—and exploring collaboration and coordination with clinical trial networks in Mainland China. Collaboration between Hong Kong and the Greater Bay Area Zone (GBA) in Guangdong Province envisages more clinical trials and drug reviews being carried out in Mainland China, and also allows Mainland-manufactured drugs to be tested and approved in Hong Kong. In 2020, Mainland China established the GBA, where drugs for which there are clinical need and that are marketed in Hong Kong and Macao can obtain limited local approval prior to being approved in Mainland China.
The new regime is likely to be more efficient if successfully implemented. Realistically, however, the change to the current regime may take some time to accomplish. In the interim, Hong Kong will likely continue to take considerable reference from international drug regulatory authorities while developing its own medical products primary evaluation capacity.
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