Since their inception, the University of Macau’s (UM) State Key Laboratory of Quality Research in Chinese Medicine (SKL-QRCM) and the Institute of Chinese Medical Sciences (ICMS) have achieved numerous scientific advancements in Chinese medicine innovation. To transform these research outcomes into practical products and support the development of Macao’s Chinese medicine industry, UM has, in recent years, set up the Macao Centre for Research and Development in Chinese Medicine, the Macao Centre for Testing of Chinese Medicine, and the Centre for Pharmaceutical Regulatory Sciences, forming a comprehensive system for innovation and translational research in the science and technology of Chinese medicine.’   

 

Developing innovative Chinese medicine products

 

In 2020, leveraging the growth of the Guangdong-Hong Kong-Macao Greater Bay Area, SKL-QRCM established the Macao Centre for Research and Development in Chinese Medicine (MCR&DCM), Macao’s first dedicated platform for the innovation, research, development, and translation of Chinese medicine. MCR&DCM collaborates with leading pharmaceutical companies and research institutions, including Guangzhou Pharmaceutical Corporation, China Resources Sanjiu Medical & Pharmaceutical Co Ltd, Pien Tze Huang Pharmaceutical Co Ltd, China Resources Jiangzhong Pharmaceutical Group Co Ltd, the Institute of Chinese Materia Medica at the China Academy of Chinese Medical Sciences, and the Centre for Chinese Herbal Medicine Drug Development in Hong Kong. By focusing on modernising classical prescriptions, enhancing established product lines, and developing premium health products, MCR&DCM aims to consolidate resources in the Chinese medicine industry’s supply chain to drive the development of the Chinese medicine sector in Macao.

 

Prof Li Peng, deputy director of ICMS and director of MCR&DCM, explains that MCR&DCM is dedicated to supporting the diversification of Macao’s economy. To this end, the centre has collaborated with leading pharmaceutical companies on over 20 projects. These projects include developing traditional formulas such as Baoyuan Decoction (to improve vitality), Banxia Xiexin Decoction (to improve digestion), and Astragalus and Cinnamon Twig Decoction (to improve circulation); popular remedies such as Zishen Yutai Pills and Xiaoer Qixing Cha; and health products such as Ganoderma spore oil and Agaricus bisporus polysaccharides. The centre has also facilitated the introduction of products such as Ganoderma lucidum spore oil soft capsules, developed by GPHL International, into the Macao market.

 

Prof Li Peng adds that with the rapid development of a medical innovation platform characterised by independent intellectual property rights and Chinese features in the Guangdong-Macao In-depth Cooperation Zone in Hengqin, MCR&DCM is actively partnering with enterprises and research institutions in Hengqin. The centre strives to leverage the advantages of the ‘one country, two systems’ policy and incorporate resources from the mainland to advance the Chinese medicine industry.

 

Providing Chinese medicine testing services

 

Chinese medicine products must undergo rigorous examination and testing before they are launched in the market. To meet Macao’s growing demand for these services, and with the support of the Macao SAR Government, UM commenced creation of the Macao Centre for Testing of Chinese Medicine (MCTCM) in July 2021. MCTCM was established on 12 January 2022, and officially came into operation in November 2024.

 

Distinguished Professor Li Shaoping, deputy director of SKL-QRCM and director of MCTCM, says, ‘The Macao SAR Government and the university place a strong emphasis on Chinese medicine testing. Over the past two years, MCTCM has been committed to building a quality management system, enhancing testing capabilities, fostering partnerships, and expanding service offerings. The centre has also taken part in several testing capability assessments.’ In May 2023, MCTCM’s first testing service—measuring levels of lead, cadmium, arsenic, mercury, and copper in Chinese medicinal ingredients—was accredited by the China National Accreditation Service for Conformity Assessment (CNAS).

 

By September 2024, 118 Chinese medicine testing services provided by MCTCM had passed CNAS’s expanded and supervisory assessments. Prof Li says, ‘Our accredited testing services now basically cover the standards in the Chinese Pharmacopoeia, and include a range of chemical and microbiological tests. In terms of chemical analyses, we test for heavy metals, hazardous elements, sulphur dioxide residues, aflatoxins, and 33 banned pesticides. We are also equipped to identify and quantify content levels. For microbiological testing, our parameters include microbial limits and control strains.’

 

Prof Li adds that another goal of the centre is to facilitate the application of pharmaceutical research outcomes in Macao. ‘The centre is dedicated to enhancing its professional influence and positioning Macao as a leader in establishing quality standards for Chinese medicine. By developing a testing and certification industry for Chinese medicine with Macao characteristics—where quality is the core focus, standards provide guidance, testing serves as a key tool, and certification is the ultimate goal—our centre aims to ensure rigorous quality assurance for products that are developed, approved, and certified in Macao.’

 

Advancing pharmaceutical regulatory sciences

 

In 2023, the permanent secretariat of the Western Pacific Regional Forum for the Harmonization of Herbal Medicines was established at UM. The secretariat is committed to building a service platform for economic and trade cooperation in the Chinese medicine industry, as well as promoting research and related work for establishing regional and international standards for herbal products and developing technical requirements for product registration, in order to promote Macao’s role as a key coordinator in the global development of Chinese medicine.

 

Also in 2023, UM established the Centre for Pharmaceutical Regulatory Sciences (CPRS). The centre is dedicated to building a sustainable platform to strengthen regulatory capabilities for healthcare products in Macao and across the Guangdong-Hong Kong-Macao Greater Bay Area. Prof Hu Yuanjia, director of CPRS, says that the centre’s key functions include assisting the Pharmaceutical Administration Bureau of Macao with technical evaluations of proprietary Chinese medicines and medical devices; conducting research on regulatory science, policy, and legal frameworks; developing new regulatory tools, standards, and methods for drug evaluation and regulatory decision-making; and undertaking government and industry research projects. The centre is also dedicated to cultivating talent in regulatory science and organising relevant training and exchange programmes.

 

Moreover, CPRS actively promotes collaboration. The centre recently hosted the 1st Macau International Forum on Pharmaceutical Regulatory Science—High-Quality Development of Chinese Medicines: Theory and Practice. The forum brought together pharmaceutical regulatory experts, scholars, and policymakers from Macao, mainland China, Southeast Asia, Portuguese-speaking countries, and beyond, aiming to establish a collaborative and exchange platform among industry, academia, research institutions, and government departments in medical product regulation and innovation. Prof Hu says, ‘CPRS will keep expanding its role to further support the development of pharmaceutical services and the industry in Macao.’

 

Establishing quality standards for Chinese medicine

 

Internationally recognised quality standards are essential to bringing Chinese medicine to the global market. Therefore, SKL-QRCM is actively developing innovative quality analysis methods and international standards. The unit has established joint laboratories with the United States Pharmacopeia Convention, the European Pharmacopoeia Commission, and China’s National Institutes for Food and Drug Control, respectively. These joint laboratories have completed or are working on including more than 20 Chinese medicine quality standards in the United States Pharmacopeia, European Pharmacopoeia, and Chinese Pharmacopoeia. These standards cover key medicinal ingredients, including Panax notoginseng, ophiopogon root, goji berries, cordyceps militaris, artificial cordyceps powder, galangal, dendrobium, patchouli, and amla.

 

When it comes to the establishment of Chinese medicine quality standards, SKL-QRCM focuses on core quality elements and developing innovative methods and applications. In 2016, SKL-QRCM, ICMS, and Peking Union Medical College conducted a research project focused on using DNA barcoding for species identification of medicinal plants, which was awarded a second prize of the State Scientific and Technological Progress Award.

 

Committed to making a social impact

 

From drug development to product and service launch, and ultimately to promoting the development of the Chinese medicine industry, this journey is long and full of challenges. The process requires close collaboration between government departments, research institutions, and industry. Throughout this process, UM is committed to translating more Chinese medicine research results into practical applications, thus making contributions to the sustainable development of the Chinese medicine industry. 

 

 

Chinese & English Text / Davis Ip

Photo / Jack Ho, Editorial Board

Source: UMagazine ISSUE 30

 

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