Published: 17:58, October 27, 2023 | Updated: 18:37, October 27, 2023
Health chief: HK aims for global drug, medical devices authority
By Xi Tianqi in Hong Kong

In this file photo dated Feb 4, 2020, medical staffs are seen outside Princess Margaret Hospital in Hong Kong, China. (PHOTO / AFP)

The Hong Kong Special Administrative Region’s health chief Lo Chung-mau said the healthcare sector aims to establish itself as an internationally recognized regulatory authority for drugs and medical devices. 

To this end, Hong Kong is set to leverage the advantages of the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) with a strong emphasis on clinical research.

The office will eventually transition from the  “1+” mechanism to a  “primary evaluation” system, eliminating the need for external approval bodies and enabling Hong Kong to independently evaluate clinical data and review drugs 

At a briefing on Friday, Lo highlighted Hong Kong’s role as a gateway connecting the nation to the international community. He expressed the city’s aspiration to develop an internationally recognized approval mechanism for new drugs, distinct from the Chinese mainland's existing regulatory process.

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Lo said that the development of the GBA presents a significant opportunity for Hong Kong. By capitalizing on the region’s substantial patient base and combining it with Hong Kong’s expertise in clinical research, the city would be able to attract multinational pharmaceutical and medical device companies to conduct research and development activities locally, and the relevant results could also be tried and applied in the GBA. 

This is a good case of making full use of the advantage of “two systems” under the “one country, two systems” principle, Lo said. 

Starting next month, Hong Kong will introduce the new  “1+” mechanism within its existing drug system, allowing new pharmaceutical products for life-threatening or severely-debilitating diseases to be registered conditionally with only one certificate of pharmaceutical product issued by drug regulatory authorities, down from the current requirement of two. 

In the meantime, the government proposed in its newly announced Policy Address to establish a preparatory office for the Hong Kong Centre for Medical Products Regulation (CMPR) within 2024, which is tasked to carry out a comprehensive study to explore potential enhancements to the current regulatory and approval regimes for medicines, medical devices, and medical technology. 

The office will eventually transition from the  “1+” mechanism to a  “primary evaluation” system, eliminating the need for external approval bodies and enabling Hong Kong to independently evaluate clinical data and review drugs.

In a bid to enhance Hong Kong's international standing, the city will strive to join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer, a move supported by the National Medical Products Administration. 

Lo estimated that achieving membership in the ICH and gaining international recognition for drugs registered in Hong Kong will likely take around eight to 10 years.

Another key initiative to this end is the establishment of the GBA International Clinical Trial Institute in the Hetao Co-operation Zone in the city’s border site of Lok Ma Chau. This institute aims to fully utilize the advantages of both Hong Kong and the mainland cities of the GBA, gaining recognition not only at the national level but also internationally.

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Lo said by facilitating the free flow of data and samples within the zone and establishing shared databases, sample repositories, and laboratories, Hong Kong seeks to create a dynamic platform for both importing and exporting medical research.

Lo said that a connected support office will be set up to encourage teams to participate and expedite various research processes, including ethical considerations. Efforts will also be made to enhance systems and mechanisms for data sharing within the healthcare sector.

Additionally, he explained that the 2023 Policy Address introduced the concept of a cross-boundary ambulance service, which aims to transport stabilized patients back to Hong Kong, ensuring compliance with local medical standards.