The Department of Health (DH) in Hong Kong has established a preparatory office aimed at laying the groundwork for the formation of the Centre for Medical Products Regulation (CMPR). This new office will suggest procedures for the formal establishment of CMPR and examine potential adjustments to regulatory and approval frameworks within Hong Kong.
In the 2023 policy address, the government unveiled intentions to harness the medical expertise of the Hong Kong Special Administrative Region in advancing the overarching objective of instituting an entity tasked with registering drugs and medical devices using the "primary evaluation" method. This approach involves the direct approval of medical products for local use in Hong Kong, utilizing clinical trial data, and bypassing the need for approvals from external drug regulatory bodies.
The government views primary evaluation as a means to expedite the clinical adoption of emerging drugs and medical devices while bolstering industry support. The aim is to revamp and fortify the regulatory and approval processes for drugs and medical devices, positioning Hong Kong as a global hub for health and medical innovation.
Establishing the preparatory office marks the third milestone in the government's roadmap to establish a globally acknowledged regulatory authority. The initial two steps involved Hong Kong's accession as an observer to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the establishment of a novel mechanism for new drug approvals. Dubbed the "1+" mechanism, it permits holders of registration from a recognized drug regulatory authority to pursue approval in Hong Kong.
The creation of the preparatory office will support the next three steps. Officials have tasked the office with studying and planning a regulatory and approval regime for drugs and medical devices suitable for Hong Kong. The work will inform proposals for establishing the CMPR. The office will also assess the need to amend existing legislation to promote the development of medical products regulation and offer advice to the Steering Committee on Health and Medical Innovation and Development.
The government's efforts are geared towards establishing CMPR by 2026 or 2027. Following this, Hong Kong aspires to implement a primary evaluation system and attain membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Typically, it takes between eight to ten years from the initial engagement with ICH to achieve regulatory membership in the international organization. Hong Kong officially assumed observer status in the ICH in 2023.
Although some elements of the plan are still several years from fruition, the government is already experiencing the effects of the initial stages of the strategy. Since the implementation of the 1+ mechanism in November, Hong Kong's DH has fielded 210 inquiries from approximately 70 pharmaceutical firms. Utilizing this mechanism, which enables companies with local clinical data to seek approval using only one rather than two authorizations from recognized regulatory bodies, Hong Kong has already approved two cancer drugs.
