Following is a question by the Hon Stanley Ng and a written reply by the Secretary for Health, Professor Lo Chung-mau, in the Legislative Council today (October 7):
 
Question:
 
     The Outline Development Plan for the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) expressly supports Hong Kong in leveraging the strengths of its Chinese Medicines Testing Institute. With the official release of the first batch of GBA Chinese medicines standards (GBA Standards) at the end of October 2024, coupled with the successive commissioning of the Chinese Medicine Hospital of Hong Kong and the Government Chinese Medicines Testing Institute (GCMTI), the development of Chinese medicine (CM) in Hong Kong is entering a critical transformation period of standardisation, professionalisation and internationalisation. However, members of the CM industry have reflected that the formulation of some of the current Hong Kong Chinese Materia Medica Standards (Hong Kong standards) is overly focused on physicochemical identification, creating a gap with the national CM standards (national standards) and the actual operations of local small and medium-sized pharmaceutical manufacturers, and that there is also a lack of an efficacy evaluation mechanism centred on the holistic approach of CM. In this connection, will the Government inform this Council:
 
(1) given that the first batch of GBA Standards released covers a total of seven Chinese herbal medicines and proprietary CMs, whether the Government has formulated specific timetables and performance indicators for aligning more commonly used Chinese herbal medicines, proprietary CMs and clinical guidelines with the GBA Standards;
 
(2) how the Government will leverage the scientific research capabilities of GCMTI to promote the alignment of the GBA Standards with the standards formulated by international standardisation organisations (such as the Technical Committee for Traditional Medicine of the International Organization for Standardization (ISO/TC249)), and promote such standards to overseas markets;
 
(3) given the views that the use of CM emphasises that medication varies from person to person, that the efficacy of proprietary CMs is difficult to evaluate, and that the GBA Standards impose extremely high requirements on physicochemical identification, making it relatively difficult for local small and medium-sized pharmaceutical manufacturers to align with such standards, resulting in relatively low market adoption of the standards, and also leading many local institutions to directly adopt products conforming to the national standards (such as CM formula granules), whether the Government will review the direction of establishing the Hong Kong standards in the future, so as to ensure that the Hong Kong standards can align with the CM theoretical system and actual market demand; and
 
(4) given that the registration system for CM Practitioners in Hong Kong has been in place since 2000, but the professional benchmarks and statutory registration system for CM pharmacists have yet to be implemented, whether the Government has formulated a specific timetable for promoting the professionalisation and institutionalisation of CM pharmacists, so as to safeguard the safe use of drugs by the public; if so, of the details; if not, the reasons for that?
 
Reply:
 
President,

     The Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Chinese Medicines Standards (the Standards) aims to co-ordinate quality and safety standards of Chinese medicines (CMs) within GBA, promote mutual recognition and circulation of CMs and facilitate high quality development of the industry. Expert Committee of the Standards (the Expert Committee), jointly established by the drug regulatory authorities of the three places including Guangdong, Hong Kong and Macao, formulates harmonised standards for the industry's reference through discussion at meetings. The selection, verification, and publication of the Standards have to be discussed by the Expert Committee, and published by batches in an orderly manner having regard to the actual situation of the three places.
      
     In consultation with the Department of Health (DH), a consolidated reply to the Hon Stanley Ng's question is provided as follows:
     
(1), (2) and (3) The first batch of the Standards was promulgated on October 29, 2024, covering seven items, namely Chenpi (Guangchenpi), Huajuhong, Huajuhongtai (huajuhongzhu), Banlangen Keli, Xiasangju Keli, Shexiang Huoluo You and Zhangquan Potong You. The General Rules for the Chinese medicines standards and Safety Quality Control Items for Traditional Chinese Medicine in the Guangdong-Hong Kong-Macao Greater Bay Area (the General Rules) was also promulgated at the same time.
 
     To enhance mutual recognition and circulation of CMs, drug regulatory authorities of the three places are establishing more standards for commonly used Chinese herbal medicines (Chms) and proprietary Chinese medicines in an orderly manner through the Expert Committee mechanism, considering the needs of the industry. The second batch of the Standards was promulgated on August 31, 2026, covering seven items, namely Bajitian, Guizhi, Huajuhong (You) Peifangkeli, Jinyinhua Peifangkeli, Sharen (Yangchunsha) Peifangkeli, Xiaochaihu Keli and Zhibai Dihuang Wan, together with the revised General Rules.
 
     The Standards serves as the technical standards of the three places and is neither to replace the statutory standards of the Government of the Hong Kong Special Administrative Region (HKSAR) or Chinese Mainland, nor a mandatory standard for the industry to adopt. As such, the Government Chinese Medicines Testing Institute (GCMTI) of DH also continues to advance the development of the Hong Kong Chinese Materia Medica Standards (HKCMMS), establishing safety and quality standards for some commonly used Chms in Hong Kong and strive for aligning with the formulation of international standards. HKCMMS provides a reference standard of Chms for the Chinese medicine (CM) industry, also promotes research in CMs to facilitate its modernisation and internationalisation, thereby encouraging international trade in CMs. The content of HKCMMS includes the names, source, description, identification, tests, extractives, assay and chemical structure of reference substances. To date, the GCMTI has published 12 volumes of HKCMMS, covering 357 types of Chms.
 
     An International Advisory Board (IAB) under HKCMMS project, comprising of herbal medicine experts from the HKSAR, Chinese Mainland and overseas regions, is responsible for reviewing the standards for Chms. The objective of HKCMMS is to precisely align with the CM theoretical framework and market demands, while ensuring the incorporation of views from the local and Chinese Mainland industry through IAB. HKCMMS has been frequently cited by authoritative overseas institutions; for example, 28 CM relevant International Organization for Standardization (ISO) documents cited the heavy metal limits and other information set out in HKCMMS as reference. HKCMMS has also been cited in over 420 international journal articles. Furthermore, the Chinese Medicine Regulatory Office (CMRO) of the DH has been designated by the World Health Organization (WHO) as a Collaborating Centre for Traditional Medicine since 2012, providing technical support to WHO in developing the standards of herbal medicines and implementing its strategies and standards for traditional medicine. In June 2026, DH supported WHO in organising a conference in Hong Kong to discuss the development of the first volume of the International Herbal Pharmacopoeia and assisted WHO in drafting part of the monographs and general chapters on herbal medicines.
 
     In terms of international promotion, the DH fully leverages the unique advantages of Hong Kong in having strong support of the motherland and being closely connected to the world, to actively develop and participate in efforts to promote CM to go global, in co-operation with the national strategy to promote CM's global expansion, standardisation and matters related to strategic CMs management. In addition to the aforesaid contributions to standard setting and WHO herbal medicines standards, CMRO also continues to actively promote scientific research findings to the international community through authoritative platforms, such as the Western Pacific Regional Forum for the Harmonization of Herbal Medicines and the International Regulatory Cooperation for Herbal Medicines. In 2025, Hong Kong hosted the 7th Guangdong-Hong Kong-Macao Greater Bay Area Conference on the Inheritance, Innovation, and Development of Traditional Chinese Medicine, which representatives from WHO were invited to join and exchange views on the future direction of the global development of traditional medicine and standards for CMs.
 
(4) The standards and recognition of healthcare professionals are promoted by the relevant professions in accordance with the principle of professional autonomy. In regulating healthcare professions, the Government adopts a risk-based approach in determining the most suitable mode of regulation applicable to an individual healthcare profession, based on the level of risk posed on public health, healthcare quality and public safety when providing services. The Chinese Medicine Development Blueprint (the Blueprint) sets out various measures to promote CMs regulation, quality enhancement and innovative research and development in Hong Kong. Among other things, CMs talents cultivation is a key driver of the CMs development in Hong Kong.
 
     At present, CMs professionals in Hong Kong have a wide scope of work and a diverse range of functions, and the competence standard of CMs professionals in different fields have yet been comprehensively established. Action 6.2 of the Blueprint explicitly proposes empowering the industry to cultivate talents in CMs and intends to establish a dedicated working group under the future sector advisory structure. This working group will bring together relevant stakeholders from the Chinese Mainland and the local CMs sector to discuss models for the continuing education and development of CMs professionals. The Blueprint also proposes leveraging the Chinese Medicine Development Fund to promote collaborative efforts among stakeholders to conduct research on the core competence for talents in the CMs sector, with a focus to clarify the alignment between professional competence and industry development needs, thereby laying the groundwork for future exploration of continuous professional development requirements and regulation for CMs personnel. The Government will align with the development direction sets by the CMs sector for its professionals and maintain continuous communication with the industry.

Ends/Wednesday, October 7, 2026
Issued at HKT 15:00

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