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Preparatory Office for the Hong Kong Centre for Medical Products Regulation - Latest Updates

Date Title
06.12.2025 2025 Learning from Neighbours: Fostering an Eco-system for Medical and Pharmaceutical Advancement

The Chief Pharmacist Mr. Kevin Lam of the Preparatory Office for CMPR was invited to speak at the captioned forum co-organised by the Hong Kong Association of the Pharmaceutical Industry (HKAPI), the Centre for Pharmaceutical Regulatory Sciences (CPRS), University of Macau and the Pharmaceutical Society of Macao. Mr. Lam presented Hong Kong’s policy and regulatory initiatives that drive medical products innovation and regulatory excellence to an audience of over 100 industry representatives from Hong Kong, Macao, etc. Mr. Lam subsequently took part in the panel discussion, engaging in in-depth exchanges with fellow speakers and participants.

2025 Learning from Neighbours: Fostering an Eco-system for Medical and Pharmaceutical Advancemen
2025 Learning from Neighbours: Fostering an Eco-system for Medical and Pharmaceutical Advancemen
18.11.2025 Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA
Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA
27.10.2025 The 2025 China BioMed Innovation and Investment Conference (CBIIC)

The Chief Pharmacist Mr. Kevin Lam of the Preparatory Office for CMPR was invited to deliver a keynote speech at the HK Health Industry Forum, as part of the captioned conference organised by the China Pharmaceutical Innovation and Research Development Association (PhIRDA).

Mr. Lam shared to the audience the current status of the establishment of CMPR, including work to drive regulatory excellence, the roadmap for phased implementation of primary evaluation and the vision of establishing an internationally renowned regulatory authority, for a greater contribution to global public health.

The 2025 China BioMed Innovation and Investment Conference (CBIIC)
The 2025 China BioMed Innovation and Investment Conference (CBIIC)
22.10.2025 DIA Global Regulatory Policy Forum – Beijing 2025

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, was invited to participate in a panel discussion session in the captioned forum organised by the Drug Information Association (DIA).

During the discussion, Mr. Chan shared about the importance of regulatory collaboration and Hong Kong’s plan to set up the CMPR to make greater contribution to public health protection of our region and to better position Hong Kong to actively participate in the trends of health and medical innovation in Asia, especially the Chinese Mainland.

DIA Global Regulatory Policy Forum – Beijing 2025
DIA Global Regulatory Policy Forum – Beijing 2025
26.09.2025 DIA Special Conference on the Greater Bay Area & The 2nd Macau Forum on Pharmaceutical Regulatory Science

Mr. Lot Chan, Assistant Director of Health (Preparatory Office for CMPR) attended the captioned conference co-organised by the Centre for Pharmaceutical Regulatory Sciences, University of Macau (CPRS) and the Drug Information Association (DIA).

Mr. Chan delivered a presentation on the development of regulatory science and strategic positioning of Hong Kong. The audience included professionals from regulatory science, pharmaceutical R&D, clinical trial institutions, academia, and clinical research organisations.

Following the presentation, Mr. Chan was invited to a panel discussion to explore the regulatory regional coordination and resources integration.

DIA Special Conference on the Greater Bay Area & The 2nd Macau Forum on Pharmaceutical Regulatory Science
DIA Special Conference on the Greater Bay Area & The 2nd Macau Forum on Pharmaceutical Regulatory Science
13.09.2025 Director of Health presents HK's medical innovation development at 2025 Capital International Medical Congress in Beijing Director of Health presents HK's medical innovation development at 2025 Capital International Medical Congress in Beijing
10.09.2025 BIOHK 2025: Global Regulatory Shifts: Hong Kong’s CMPR New Era – Strategies for Biopharma

The Assistant Director of Health (Preparatory Office for CMPR) Mr. Lot Chan, shared in the BIOHK 2025 to participants from pharmaceutical industry, research and testing sector, academia on the preparation work for CMPR establishment, priority strategic areas, as well as primary evaluation. He also elaborated on current global regulatory landscapes, Hong Kong’s edges, medical R&D ecosystems, etc. The Government is leveraging its strategic position and strengths to establish the CMPR, in order to seize the opportunity to strengthen its role as the “Super Connector”.

During the ensuing panel discussion session, panelists explored ideas relating to application of artificial intelligence in medical products regulation, creation of CMPR values, and engagement of talents by regulators.

BIOHK 2025: Global Regulatory Shifts: Hong Kong’s CMPR New Era – Strategies for Biopharma
BIOHK 2025: Global Regulatory Shifts: Hong Kong’s CMPR New Era – Strategies for Biopharma
10.09.2025 Guangdong–Hong Kong–Macao Greater Bay Area Biomedical Industry Exchange Meeting, Hong Kong

The Chief Pharmacist Mr. Kevin Lam of the Preparatory Office for CMPR attended the captioned meeting organised by the Department of Commerce of Guangdong Province and delivered a speech. Mr. Lam shared to the participants the timetable for establishing the CMPR, and upcoming implementation of primary evaluation. He also gave details on Hong Kong “1+” mechanism for new drug registration which facilitates innovative pharmaceutical products developed in the Mainland to obtain registration in Hong Kong, and how Hong Kong could serve as a springboard for Mainland enterprises to develop markets globally. He also remarked that the Department of Health is dedicated to optimising medical products regulatory system and enhancing collaborations with overseas regulatory authorities and international organisations, with the aim of establishing potential mutual recognition and regulatory reliance.

Officials from relevant authorities of GBA cities such as Guangzhou, Zhuhai, and Zhongshan were also in attendance. The meeting agenda included roadshows by representatives of biomedical enterprises from the GBA and interactive exchange session, showcasing high-quality development of the biomedical industry.

Guangdong–Hong Kong–Macao Greater Bay Area Biomedical Industry Exchange Meeting, Hong Kong
Guangdong–Hong Kong–Macao Greater Bay Area Biomedical Industry Exchange Meeting, Hong Kong
23.08.2025 Department of Health Representatives Attend 2025 Guangzhou Medical and Health Industry Expo

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, attended the 2025 Guangzhou Medical and Health Industry Expo and presented information on the access mechanism for medical products in Hong Kong to participants at the “Measure of using HK registered drugs and medical devices used in HK public hospitals in Guangdong-Hong Kong-Macao Greater Bay Area” section, including the regulatory framework of medical products, registration of Western medicines, reform of registration regime of medical products and medical products regulatory collaborations in the Guangdong–Hong Kong–Macao Greater Bay Area.

Department of Health Representatives Attend 2025 Guangzhou Medical and Health Industry Expo
Department of Health Representatives Attend 2025 Guangzhou Medical and Health Industry Expo
19.08.2025 Meeting and exchanging views with Mainland stakeholders of innovative drugs

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, met with representatives of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) and a number of Mainland pharmaceutical companies of innovative drugs, and shared with them a number of new initiatives and recent developments (e.g. “1+” mechanism for new drug registration and current progress of establishing the CMPR) related to medical products regulation in Hong Kong, which would support Mainland pharmaceutical companies of innovative drugs registering their products in Hong Kong.

Participants actively offered suggestions and provided valuable comments for the future developments of the CMPR.

Meeting and exchanging views with Mainland stakeholders of innovative drugs
13.08.2025 Hong Kong and Singapore Strengthen Cooperation on Regulation of Drugs and Medical Devices

The Director of Health, Dr Ronald Lam, and the Chief Executive Officer of the Health Sciences Authority (HSA) of Singapore, Professor Raymond Chua, signed a Memorandum of Understanding (MOU) on 13 August 2025. The MOU aims to enhance cooperation between the two places in areas such as medical products regulation, promoting regulatory capacity enhancement and training, with a view to jointly promoting the high-quality development of the regulation of medical products.

Hong Kong and Singapore Strengthen Cooperation on Regulation of Drugs and Medical Devices
12.08.2025 Director of Health’s Singapore Visit

The Director of Health, Dr Ronald Lam, accompanied the Secretary for Health, Professor Lo Chung-mau, on a three-day visit to Singapore. During the visit, they met with representatives from the Consortium for Clinical Research and Innovation, Singapore, the Health Sciences Authority, the Duke-NUS Centre of Regulatory Excellence and a multi-national pharmaceutical company. The delegation gained understanding on Singapore’s latest developments in medical products regulation and insights into its strategies for fostering medical innovation. They also introduced to Singapore regulatory agency and organisations about Hong Kong’s ongoing regulatory reforms and policy initiatives supporting the transformation of biomedical innovation.

Director of Health’s Singapore Visit
Director of Health’s Singapore Visit
30.07.2025 Meeting and exchanging views with HKSTP on medical products R&D in Hong Kong

Representatives of the Department of Health visited the Hong Kong Science Park in Shatin. They met with Mr. Eric OR, Acting Chief Corporate Development Officer of Hong Kong Science & Technology Parks Corporation (HKSTP) and his team. Updates on the progress of establishment of the CMPR and the roadmap for the implementation of “primary evaluation” mechanism for new drug registration were shared to HKSTP. Opportunities for collaborations between the two parties were also explored.

The visit included a tour of facilities in Hong Kong Science Park and an introduction of HKSTP’s measures relating to pre-clinical study testing.

Meeting and exchanging views with HKSTP on medical products R&D in Hong Kong
25.07.2025
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01.08.2025
Featured Interview at Metro Finance "我的事務所": "生物科技" (Part 1) – The Upcoming Development of the CMPR

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, shared in the programme that the Department of Health would begin phased implementation of “primary evaluation” for new drugs in 2026, aiming to attract pharmaceutical companies from both overseas and Chinese Mainland to register their products in Hong Kong, thereby expediting their access.

The “primary evaluation” approach allows Hong Kong to assess and approve new drugs independently through its own robust system, and expedite the clinical application of new drugs.

Featured Interview at Metro Finance "我的事務所": "生物科技" (Part 2) – The Upcoming Development of the CMPR

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, highlighted in the programme on how CMPR would attract pharmaceutical companies to prioritise Hong Kong as their entry point into the market through gaining international recognition and leveraging its strategic advantages. This initiative would promote access to more diverse and affordable treatment options for Hong Kong citizens.

15.07.2025 Department of Health Representatives Attend 2025 Drug Information Association (DIA) Singapore Annual Meeting

The Principal Medical & Health Officer (Medical Device), Dr. Ambrose Wong, represented the Department of Health to attend the 2025 DIA Singapore Annual Meeting and presented the latest regulatory updates in Hong Kong, including the progress of establishment of the CMPR and the roadmap for implementing the “primary evaluation” mechanism for new drug registration.

Dr. Wong then joined the panel to discuss on issues such as means to ensure the regulatory system is efficient, sustainable and fit-for-purpose to enable faster approval of innovative healthcare products.

Department of Health Representatives Attend 2025 Drug Information Association (DIA) Singapore Annual Meeting
10.07.2025 Introducing New Opportunities for Innovative Drug Registration across Multinational Scientific Research and Pharmaceutical Industry

In collaboration with the Drug Office and the Hong Kong Association of the Pharmaceutical Industry (HKAPI), the Preparatory Office for the CMPR hosted the captioned seminar to brief the industry of emerging opportunities on new drug registration. The seminar was attended by over 100 industry representatives.

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, provided an update on the progress of establishment of the CMPR and outlined the roadmap for the implementation of “primary evaluation” mechanism for new drug registration. Representatives from the Drug Office also shared the current implementation status regarding the “1+” mechanism for new drug registration.

The session was concluded with an engaging Q&A, where participants actively sought guidance for their effective planning of new product registration applications.

Introducing New Opportunities for Innovative Drug Registration across Multinational Scientific Research and Pharmaceutical Industry
27.06.2025 Featured Interview at RTHK "千禧年代" – The CMPR will be Established by the End of 2026 (Chinese only)

The Assistant Director of Health (Preparatory Office for CMPR), Mr. Lot Chan, presented the timetable, strategic areas and current progress of establishing the CMPR during the programme. He elaborated on the phased implementation of the “primary evaluation” mechanism for new drug registration, which would commence in 2026 and be fully implemented by 2030 to cover all kinds of pharmaceutical products. The “primary evaluation” approach allows Hong Kong to assess and approve new drugs independently through its own robust system, and expedite the clinical application of new drugs.

Featured Interview at RTHK 千禧年代 –  The CMPR will be Established by the End of 2026
26.06.2025 DH announces timetable for establishing CMPR and roadmap towards phased implementation of "primary evaluation" (with photos/video) DH announces timetable for establishing CMPR and roadmap towards phased implementation of primary evaluation (with photos/video)
11 Dec 2025