Hong Kong Establishes Preparatory Office for Medical Products Regulation Centre

On June 5, Hong Kong’s Department of Health (DH) announced the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR). This initiative seeks to enhance the regulatory and approval processes for pharmaceuticals and medical devices in Hong Kong.

Following the Chief Executive’s 2023 Policy Address, which emphasized utilizing Hong Kong’s medical strengths to establish a primary evaluation authority for medical products, significant progress has been made. The goal is to facilitate direct approval of medical products based on local clinical trial data, which will help enhance Hong Kong’s status as a global health and medical innovation hub.

Key milestones include Hong Kong’s recognition as an observer of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the implementation of the “1+” mechanism, which streamlines the drug registration process. Since November 2023, this new policy has resulted in over 210 inquiries from 70 pharmaceutical companies and the approval of two new cancer treatment drugs.

The Preparatory Office will:

1. Study and plan a suitable regulatory framework
2. Propose steps for establishing the CMPR.
3. Review and potentially modify existing legislation.
4. Make recommendations to the Steering Committee on Health and Medical Innovation and Development and maintain stakeholder communication.

The Hong Kong government hopes these efforts will further attract international pharmaceutical and medical device companies to come to Hong Kong.