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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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.