The Secretary for Health, Professor Lo Chung-mau, met with a delegation led by the Commissioner of the National Medical Products Administration (NMPA), Mr Li Li, today (May 8) to exchange views on fostering development of policy subjects such as approval of drugs and medical devices, clinical trials, and Chinese medicine (CM) on the Mainland and Hong Kong.
Professor Lo said, "The Guangdong-Hong Kong-Macao Greater Bay Area has been ushering in immense opportunities for medical and biotechnological developments in recent years. The National 14th Five-Year Plan has expressed clear support to develop Hong Kong into an international innovation and technology (I&T) hub. The Development Plan for Shenzhen Park of Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone promulgated by the State Council in August last year also put forward 30 measures on ways to work towards synergistic collaboration between the Hong Kong Special Administrative Region (HKSAR) and Shenzhen in promoting international I&T.
"The Chief Executive subsequently announced in the 2023 Policy Address that the HKSAR Government will enhance the prevailing evaluation, approval and registration mechanism for drugs as well as establish an internationally recognised regulatory authority for drugs and medical devices with the long-term objective of setting up an authority which registers drugs and medical devices under the 'primary evaluation' approach. All these aim at accelerating the clinical use of new drugs and medical devices, and spurring the development of industries relating to the research, development and clinical testing of drugs and medical devices.
"Following the announcement of the Policy Address, the HKSAR Government has been making proactive moves on all fronts and has scored certain achievements in just six months, including the formal acceptance by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as its observer and the implementation of the new drug approval mechanism, known as the '1+' mechanism, respectively on October 31 and November 1 last year. The HKSAR Government will set up the preparatory office for the Hong Kong Centre for Medical Products Regulation (CMPR) in the first half of this year to study the restructuring and strengthening of the regulatory and approval regime for drugs, medical devices and technologies, and put forward proposals and steps for establishing the CMPR which will be a step towards the transition to the 'primary evaluation' approach."
Moreover, the HKSAR Government will establish the Greater Bay Area International Clinical Trial Institute (GBAICTI) in the Hetao area by the end of this year. The GBAICTI will provide one-stop clinical trial support services, with a view to further ramping up the capacity and efficiency of clinical trials in Hong Kong and transforming the city into a leading clinical trial hub in Asia.
Regarding CM, Professor Lo said, "To promote the innovative application of CM data and resources, the Government Chinese Medicines Testing Institute officially launched a world-class dedicated website, the Digital Herbarium for Chinese Medicines, in March this year. The Digital Herbarium showcases scientific information and data on over 220 types of commonly used Chinese materia medica and enables users to immerse themselves in a virtual tour for viewing the precious Chinese materia medica specimens donated by the NMPA to the HKSAR Government through the National Institutes for Food and Drug Control."
After the meeting, the two parties renewed the Co-operation Agreement on Regulation of Drugs and the Co-operation Agreement on Construction, Research and Management of Chinese Medicines Herbarium. At the renewal ceremony, Professor Lo said, "The Health Bureau has long been closely collaborating with the NMPA on the safety and regulation of medical products. The renewal of the Co-operation Agreement on Regulation of Drugs underpinned the liaison and co-ordination arrangements among the NMPA, the Department of Health, and the CMPR to be set up, enabling the HKSAR Government to keep leveraging the city's healthcare strengths to establish a 'primary evaluation' mechanism for the registration of drugs and medical devices, and foster collaboration between the GBAICTI and relevant Mainland organisations in staging a collaborative regional platform for clinical trials. In addition, the renewal of the Co-operation Agreement on Construction, Research and Management of Chinese Medicines Herbarium is conducive to deepening the two parties' collaboration in the field of CM regulation. Through perfecting the collection of the Chinese Medicines Herbarium, its five-pronged functions, namely science popularisation, research, testing, regulation and inheritance, will be further strengthened, assisting in the national drive for CM to go global."
The Permanent Secretary for Health, Mr Thomas Chan; the Director of Health, Dr Ronald Lam; and the Chief Executive of the Hospital Authority, Dr Tony Ko, also attended the meeting and the renewal ceremony of the Co-operation Agreements today.
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