Hong Kong: DH Sets Timeline for CMPR and Primary Evaluation Framework

In a strategic move to become a global hub for healthcare innovation, the Department of Health (DH) has announced a detailed timetable for establishing the Centre for Medical Products Regulation (CMPR) and implementing a primary evaluation mechanism for new drug registrations. These developments signal a new era of regulatory excellence and market accessibility for pharmaceutical and medical devices in Hong Kong.

CMPR to be Established by End of 2026

By the end of 2026, DH will officially launch the CMPR, which will centralize and elevate the regulatory framework for Western and Chinese medicines, as well as medical devices. This initiative is positioned to strengthen Hong Kong’s international standing as a medical innovation hub and create a more robust, harmonized regulatory environment for healthcare and MedTech stakeholders.

Roadmap Toward Full Primary Evaluation by 2030

DH also confirmed that the primary evaluation process for new drug registration will be rolled out in phases starting in 2026, with full implementation expected by 2030. The phased approach allows for time to complete infrastructure upgrades, engage stakeholders, and align regulations across sectors.

Key implementation milestones include:

• Initial phase: Focus on products with registered chemical or biological entities and expanded applications (example: new dosage forms, strengths, or indications)

• Infrastructure readiness: Enhancement of electronic platforms, introduction of good practice guidelines, and a new fee structure to streamline registration

• Full framework: A solid, internationally aligned approval system by 2030, supporting faster market entry for innovative products

  
  

The “1+” Mechanism

The groundwork for primary evaluation was laid with the “1+” mechanism, launched in November 2023. This policy enables new drugs to be registered in Hong Kong with approval from a single reference regulatory authority, provided they are supported by local clinical data and expert consensus – a significant shift from the earlier requirement of two reference approvals. To date, 11 new drugs have been approved under this system. Five of these 11 have already been added to the Hospital Authority Drug Formulary, expanding access to effective therapies for patients in Hong Kong.

Driving Growth and Global Connectivity

The CMPR will take a multi-pronged approach to regulatory transformation by:

• Enacting new legislation to empower the CMPR and provide a statutory framework for medical device regulation

• Strengthening capacity and efficiency, including recruitment and upskilling of regulatory professionals

• Deepening international collaboration, positioning Hong Kong as a bridge between Mainland China and the global MedTech ecosystem

• Optimizing the regulation of Chinese medicine, in line with the upcoming Chinese Medicine Development Blueprint to be released later this year

  
  

The Preparatory Office for the CMPR, established in June 2024, has made significant progress across three pillars: regulatory excellence, product innovation, and national/international cooperation

Industry Engagement and Future Momentum

DH has consulted with both the Advisory Committee on Health and Medical Innovation Development and the Steering Committee on Health and Medical Innovation Development, integrating expert recommendations into the CMPR and primary evaluation rollout strategy.

Source: Department of Health (DH)