Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA

​The 2025 Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Medical Products Administration Conferencewas convened in Hong Kong today (November 18). Representatives from the National Medical Products Administration (NMPA)and the regulatory authorities ofGuangdong, Hong Kong and Macao exchanged views on enhancing the working mechanism for regulatory collaborations on drugs and medical devices in the GBA, and fostering the innovation development on regulating drugs and medical devices in the region.

Under the guidance of the NMPA, the Conference was co-organised by the Department of Health (DH) of the Hong Kong Special Administrative Region (HKSAR) Government, the Guangdong Provincial Medical Products Administration, and the Pharmaceutical Administration Bureau of the Macao Special Administrative Region Government. Deputy Commissioner of the NMPA, Dr Yang Sheng, also attended the Conference.

Addressing at the Conference, the Secretary for Health, Professor Lo Chung-mau, said, "The Recommendations of the Communist Party of China (CPC) Central Committee for Formulating the 15th Five‑Year Plan for Economic and Social Development, adopted at the Fourth Plenary Session of the 20th Central Committee of the CPC, proposed to support the development of innovative drugs and medical devices, and to promote the inheritance and innovation of Chinese medicine and the integration of Chinese medicine and Western medicine. The HKSAR Government is fully committed to aligning with these key national strategies, leveraging Hong Kong's unique advantages of enjoying strong support of the Motherland and being closely connected to the world under the 'One Country, Two Systems' principle to develop Hong Kong into an international health and medical innovation hub and a bridgehead for Chinese medicine to go global, contributing to the high-quality development of the national pharmaceutical industry."

"Through the establishment of 'one institute, one center' in the Hetao area (i.e. the Greater Bay Area International Clinical Trial Institute in the Hong Kong Park of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone and the Greater Bay Area International Clinical Trials Center (GBAICTI) in the Shenzhen Park) and the formation of the 'GBA Clinical Trial Collaboration Platform', we are promoting international multi-centre clinical trials of innovative drugs and medical devices, gathering top-tier global research resources and accelerating the transformation of research and development outcomes. By 2026, the Hong Kong Centre for Medical Products Regulation (CMPR) will be established, and the 'primary evaluation' for new drug registration will be implemented in phases, expediting the transformation of CMPR into an internationally recognised regulatory authority for medical products. These will strongly support the high-quality development of the national biopharmaceutical industry and jointly build the GBA into a world-class health and medical innovation hub. Regarding the development of Chinese medicine, we will announce the Chinese Medicine Development Blueprint outlining the way forward for the development of Chinese medicine in Hong Kong, and injecting new momentum for Chinese medicine to go global."

The Director of Health, Dr Ronald Lam, said, "GBA serves as a leading region for medical products innovation nationwide. The medical products regulatory authorities of Guangdong, Hong Kong and Macao have a significant responsibility. We not only safeguard public health of the people, but also drive scientific innovation with regulation and enhance the country's technological capabilities and international influence. This year marks the fifth anniversary of the release of the Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the GBA. There have been steady advancements in the innovative development of medical products regulation in the GBA, leading to fruitful achievements for Hong Kong in the field of medical products regulation, including the establishment of a real-time risk communication system, enhanced personnel and technical training, accelerated cross-boundary market access and circulation of high quality pharmaceutical and medical device products in the GBA, joint development of the standards of pharmaceutical products, and collaborative enforcement. These are some of the best examples of 'collaboration, innovation and mutual benefit' in the GBA."

At the meeting, Dr Lam also reported on the HKSAR's achievements in promoting the GBA's collaborative strength in pharmaceutical regulation. These achievements included hosting the first International Medical Device Regulatory Forum and the global "2025 Pharmaceutical Inspection Co-operation Scheme (PIC/S) Seminar" in Hong Kong. Under the "special measure of using Hong Kong registered drugs and medical devices used in Hong Kong public hospitals in GBA", 61 drugs and 73 medical devices have been allowed to be used in the 45 designated healthcare institutions. A total of 16 proprietary Chinese medicines (pCms) for external use and one pCmfor oral use, allregistered in Hong Kong, have been approved for sale in the Chinese Mainland. Additionally, one Western medicine and two Chinese medicines have been approved for production and market launch in the GBA through a new cross-boundary contract manufacturing model, under which research, development and production occur in Hong Kong while manufacturing takes place in the GBA.

During the Conference, representatives from Guangdong, Hong Kong and Macao exchanged viewson enhancing collaboration and training in drug evaluation and Good Manufacturing Practice inspection, as well as conducting international multi-centre clinical trials for innovative drugs and medical devices. In addition, the NMPA introduced the latest situation of various regulatory work, including the streamlining of approval procedures for Hong Kong- and Macao-registered traditional proprietary Chinese medicines for oral use.

Other HKSAR Government representatives at the Conference include Deputy Secretary for Health,Ms Elaine Mak, and the Controller of Regulatory Affairs of the DH, Dr Fung Ying. Representatives from the Hong Kong Hospital Authority, the GBAICTI, relevant departments from Guangdong Province and nine Chinese Mainland cities in the GBA also participated in the Conference.

Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA Source: HKSAR Government Press Releases

Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA Source: HKSAR Government Press Releases

Hong Kong hosts GBA Medical Products Administration Conference to accelerate medical products regulation and innovation development across GBA Source: HKSAR Government Press Releases

Re-launch of Reporting Scheme for Unauthorised Building Works in New Territories Exempted Houses

Following the direction of earlier proposals, the Buildings Department (BD) announced today (April 1) the re-launch of the Reporting Scheme for Unauthorised Building Works (UBWs) in New Territories Exempted Houses (NTEHs). The reporting period will last for one year from April 1, 2026 to March 31, 2027.

"In view of the history and unique circumstances of the NTEHs (commonly known as village houses), the Government launched a one-off administrative reporting scheme in 2012 as a special arrangement. Under the scheme, owners could report to the BD about UBWs that were erected before June 28, 2011, posed lower risks or constituted less serious contravention of the law. The reporting period ended in December 2012. The Development Bureau (DEVB) put forward proposals to amend the Buildings Ordinance in December 2024, which included rationalising the policy for handling UBWs. The DEVB also pointed out that in response to the views of villagers and Legislative Council members that the reporting period was too short, the Government prepared to re-launch the Reporting Scheme to allow owners who at that time did not report their UBWs to do so," a spokesman for the BD said.

Relevant stakeholders and Legislative Council members generally considered the above proposals practical and feasible, and they welcomed the proposals. The DEVB and the BD have also consulted Heung Yee Kuk on the relevant implementation arrangements.

The re-launched Reporting Scheme will maintain the original criteria, including:

(1) The types of UBWs that can be reported and their erection dates are the same as the original Reporting Scheme, meaning that only UBWs erected before June 28, 2011, posed lower risks or constituted less serious contravention of the law and were not the First Round Targets (Note) are eligible. Examples include signboards projecting from the external walls of village houses; enclosed rooftop structures with a coverage of not more than 50 per cent of the roofed-over area of the main building.

(2) Same as the original Reporting Scheme, owners are required to conduct safety inspections on the reported UBWs every five years.

"The BD will not require the immediate removal of the reported UBWs unless their structures become obviously dangerous. Regarding UBWs in village houses, the BD is prioritising the handling of First Round Targets. If any relevant UBWs remain not reported after the application deadline of March 31, 2027, the BD will, after dealing with the First Round Targets, take priority enforcement action against the non-reported UBWs. The BD will formulate enforcement strategy for the reported UBWs at a later stage in accordance with the risks and the actual situation," the spokesman added.

To enhance the efficiency of processing applications, reports must be submitted via the electronic platform on the BD's website by technically competent persons or registered professional engineers appointed by owners. In accordance with the user-pays principle, an administrative fee of $600 is payable for each application. Upon successful reports, owners must also pay the relevant administrative fee when conducting safety inspections of the reported UBWs every five years.

Details of the re-launched Reporting Scheme are available on the BD's website at https://www.bd.gov.hk/en/safety-inspection/ubw/UBW-in-new-territories-exempted-houses/index_relaunch_reporting_scheme.html; Villagers who wish to report can call 2626 1616 for enquiry. The BD will also use different channels such as distributing leaflets and posters to Rural Committees to enable villagers to know more about the re-launch of the Reporting Scheme.

Owners who had successfully participated in the Reporting Scheme in 2012 are not required to submit reports again. However, they must continue to comply with the requirements of the original Reporting Scheme, including conducting safety inspections of the reported UBWs every five years, submitting safety certificates and paying administrative fees to the BD.

Note: The First Round Targets refer to UBWs with higher potential risks and more serious nature, such as village houses of four storeys or more, and enclosed rooftop structures covering more than 50 per cent of the roofed-over area.

Source: AI-found images