DH announces timetable for establishing CMPR and roadmap towards phased implementation of "primary evaluation" (with photo/video)
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The Director of Health, Dr Ronald Lam, said, "The Hong Kong Special Administrative Region (HKSAR) Government is committed to raising regulatory standards for medical products in Hong Kong. With the establishment of the CMPR, we will consolidate regulatory functions for Western and Chinese medicines, as well as medical devices, and enhance the existing regulatory regime in a holistic manner. The vision of the CMPR is to become a "leading, internationally renowned medical products regulatory authority, driving excellence and innovation", with the goal of gaining international recognition in the field. The CMPR will promote innovation, and research and development (R&D) of drugs and devices by optimising medical products regulation. This will ensure that the public can benefit from the latest scientific research, and that patients will gain earlier access to innovative, safe and effective medical products. It also fosters growth in the local healthcare and biotechnology industries."
The DH established the Preparatory Office for the CMPR in June last year. Over the past year, preparatory work has been carried out progressively, focusing on three strategic areas: driving regulatory excellence, promoting medical product innovation, and deepening national and international collaboration.
In the future, the DH will adopt a multipronged approach for the establishment of the CMPR, with the following key areas of work:
(1) enact legislation to empower the CMPR to regulate Western and Chinese medicines and establish a statutory framework for the regulation of medical devices;
(2) continuously enhance professional capacity, strengthen regulatory efficiency, and implement "primary evaluation" in phases;
(3) deepen collaboration with local, Mainland and overseas stakeholders and regulatory authorities, strive for international recognition, and foster an innovation-friendly environment; and
(4) further optimise the regulation of Chinese medicine based on the Chinese Medicine Development Blueprint to be published by the Health Bureau in the fourth quarter of this year, leveraging the HKSAR's role as a national bridgehead for the internationalisation of Chinese medicine.
Regarding the implementation of "primary evaluation", the HKSAR Government has implemented the "1+" mechanism in November 2023. Under this mechanism, new drugs that are supported by local clinical data and recognised by relevant experts can be applied for registration in Hong Kong if the applicant provides approval from the drug regulatory authority of one of the reference places (instead of two in the past). This is an important step towards the adoption of "primary evaluation". The "1+" mechanism was extended to all new drugs on November 1 last year. Since its implementation, 11 new drugs have been approved for registration under this mechanism. Among them, five new drugs (two for treating colorectal cancer, one for treating paroxysmal nocturnal hemoglobinuria, and two for treating secondary hyperparathyroidism and certain hypercalcaemia) have already been listed on the Hospital Authority Drug Formulary, improving access to effective medications in Hong Kong.
Dr Lam said, "The DH has been proactively advancing preparatory work, including issuing good practice guides, enhancing the electronic registration platform, and introducing new registration pathways and a new fee charging mode, among others. The phased rollout of "primary evaluation" will begin next year, with full implementation by 2030. The initial phases will cover applications for the registration of products containing registered chemical entities and biological entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, etc). This will progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in the HKSAR, the Mainland, and beyond."
The HKSAR Government consulted the Advisory Committee on Health and Medical Innovation Development and the Steering Committee on Health and Medical Innovation Development in May and June 2025 respectively on the timetable for establishing the CMPR and the roadmap for implementing "primary evaluation". The HKSAR Government would like to express its sincere gratitude for the invaluable insights provided by members of both Committees.
Members of the public who wish to learn more about the timetable for establishing the CMPR and the roadmap for implementing "primary evaluation" may visit the DH's thematic webpage.
Ends/Thursday, June 26, 2025
Issued at HKT 12:00
Issued at HKT 12:00
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DH announces timetable for establishing CMPR and roadmap towards phased implementation of "primary evaluation"