Hong Kong: A New Chapter in Medical Products Regulations

On 26 June 2025, the Department of Health (DH) announced the timetable for establishing the Hong Kong Centre for Medical Products Regulation (CMPR) and the roadmap for implementing a new “primary evaluation” system.^[1] This is a major update following the establishment of the Preparatory Office for the CMPR about a year ago.

The CMPR will be established by the end of 2026. In addition to implementing the “primary evaluation” for new drug registration in phases, the CMPR will also consolidate regulatory oversight of pharmaceutical products, traditional Chinese medicine, and medical devices. Through these developments, the Government seeks to position the CMPR as a globally recognised regulatory authority and to develop Hong Kong into an international hub for health and medical innovation.

Key Summary

• Introduction of “Primary Evaluation” for Drugs: Hong Kong to move away from requiring approval from established reference authorities. From 2026 onwards, pharmaceutical products containing new chemical or biological entities will be assessed directly based on clinical trial data. This system will be implemented in phases through 2030.
• Statutory Framework for Medical Devices: A separate legislative framework is under development to align medical device regulations with international standards, create transparent approval processes, and enhance innovation.
• Implications for Life Sciences Companies: Shortened approval timelines, increased R&D incentives, clearer regulatory guidance, and stronger global competitiveness, particularly in APAC, underscore the need for proactive planning and alignment with forthcoming CMPR requirements.

New Regulatory Approach for Drugs

As a preliminary step towards “primary evaluation,” the DH introduced the “1+” mechanism in November 2023. Under this system, companies with local clinical data only need to submit regulatory approval from one reference authority, rather than two.^[2] This approach was extended to all new drugs in 2024.

Starting in 2026, Hong Kong will implement the “primary evaluation” approach for registering drugs containing new chemical or biological entities. This means that, unlike the current system, which requires one regulatory approval from reference authorities (e.g., the US FDA, EMA, or China’s NMPA), applications will be evaluated directly based on clinical trial data. This shift aims to accelerate the approval process and enhance access to innovative treatments for the Hong Kong market.

 The “primary evaluation” system will be implemented in phases:

• Phase 1 (2026 onwards): products containing registered chemical entities with extended applications (e.g., new indications, new strengths, new posology, new dosage forms, etc.);
• Phase 2: products containing registered biological entities with extended applications;
• Phase 3: new pharmaceutical products containing active substances that are not first-in-class (i.e., they use established mechanisms of action) and certain advanced therapy products; and
• Phase 4 (by 2030): full implementation covering all pharmaceutical products.^[3]

Statutory Framework for Medical Devices

In parallel, the DH is developing a statutory regulatory framework for medical devices, which is currently in the planning and legislative drafting stage. The Preparatory Office for the CMPR is actively reviewing existing legislation and consulting stakeholders to create a comprehensive regime. Key objectives include:

• Establishing clear registration and approval processes for medical devices
• Aligning with international standards to ensure safety and efficacy
• Supporting innovation by fostering a regulatory environment conducive to research and development

While specific timelines for the medical device framework are still under development, the DH is committed to working towards the above objectives to complement the drug regulation reforms.

Implications for Life Sciences Companies

These regulatory changes present significant opportunities and considerations for life sciences companies operating in or targeting the Hong Kong market:

1. Faster Market Access: The “primary evaluation” approach for drugs will reduce approval timelines, enabling quicker launch of new therapies.
2. Enhanced R&D Opportunities: The streamlined process and upcoming medical device framework will encourage clinical trials and innovation in Hong Kong, fostering partnerships with local research institutions and universities.
3. Regulatory Clarity: A statutory framework for medical devices will provide a predictable and transparent approval process, reducing compliance uncertainties.
4. Global Competitiveness: Once the CMPR is in place and fully functional, companies securing approvals in Hong Kong will be able to capitalise on the strengthened credibility to expand their presence in other markets, particularly across APAC.
5. Need for Strategic Planning: Companies should prepare for the transition by aligning clinical data submissions with the CMPR’s requirements and prepare for adjustments to application processes, fees, and registration pathways.

For further details, please refer to the official announcement (https://www.info.gov.hk/gia/general/202506/26/P2025062600281.htm) and the DH’s informational pamphlet (https://www.dh.gov.hk/english/main/main_pocmpr/files/cmpr_infobro202506_e_tc.pdf).

If you have any questions about these regulatory updates in Hong Kong, please do not hesitate to reach out to us.