Hong Kong’s DH to set up Centre for Medical Products Regulation

Hong Kong’s Department of Health (DH) has created an office to prepare for the creation of the Centre for Medical Products Regulation (CMPR). The new preparatory office will propose steps for formally establishing CMPR and study potential changes to regulatory and approval regimes in Hong Kong.

In its 2023 policy address, the government outlined plans to leverage the medical strengths of the Hong Kong Special Administrative Region to support the long-term goal of establishing an authority that registers drugs and medical devices under the “primary evaluation” approach. Primary evaluation means directly approving medical products for use in Hong Kong based on clinical trial data, without relying on approvals from other drug regulatory authorities.

The government sees primary evaluation as a way to accelerate the clinical use of new drugs and medical devices and support industry. The goal is to restructure and strengthen the regulatory and approval regimes for drugs and medical devices and make Hong Kong an international health and medical innovation hub.

Setting up the preparatory office is the third of six steps on the government’s roadmap for establishing an internationally recognized regulatory authority. The first two steps saw Hong Kong become an observer of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and set up a new mechanism for the approval of new drugs. The “1+” mechanism allows holders of registration from one recognized drug regulatory authority to seek approval.

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.

Through the work, the government is aiming to establish CMPR in 2026 or 2027. Beyond that, Hong Kong wants to establish a primary evaluation approach and secure ICH membership. The government said it typically takes eight to 10 years from initial engagement with ICH to become a regulatory member of the international organization. Hong Kong officially became an observer of the ICH in 2023.

While aspects of the plan are still years away from completion, the government is feeling the impact of the early steps in the strategy already. Hong Kong’s DH has received 210 inquiries from about 70 pharmaceutical companies since implementing the 1+ mechanism in November. Hong Kong has approved two cancer drugs using the mechanism, which allows companies with local clinical data to seek approval using one, rather than two, authorizations from recognized regulatory authorities. RAPS.org