The first “Macau International Forum on Pharmaceutical Regulatory Science—High-Quality Development of Traditional Chinese Medicine: Theory and Practice,” hosted by the Institute of Chinese Medical Sciences (ICMS) and organized by the Centre for Pharmaceutical Regulatory Sciences (CPRS) at the University of Macau, brought together over 130 renowned experts, scholars, policymakers, researchers, and students from both domestic and international backgrounds. The forum focused on the latest advancements in pharmaceutical regulatory science and aimed to contribute ideas for the collaborative development of health products in research transformation, regulation, and industry, thereby playing a positive role in promoting the development of the health industry.

During the forum, Distinguished Professor Xin Chen, the Director of ICMS and Director of the State Key Laboratory of Quality Research in Chinese Medicine at the University of Macau, delivered a welcome speech. Professor Yuanjia Hu, Director of CPRS, introduced the center’s development status. More than 20 experts provided insights on how to effectively utilize pharmaceutical regulatory science to promote the development of traditional Chinese medicine and health products.

Among them, Rong Shao, Executive Dean of the Institute of Regulatory Science at China Pharmaceutical University, analyzed macro policies related to medicine and typical pilot zone policies, offering suggestions regarding the “Guangdong-Hong Kong-Macao Greater Bay Area Interim Regulations on the Administration of Imported Pharmaceuticals and Medical Devices for Urgent Clinical Needs” policy and the development of Macau’s pharmaceutical health industry. Yue Yang, Director of the School of Pharmaceutical Sciences at Tsinghua University, detailed the regulatory requirements and characteristics of clinical trials for innovative drugs in China and analyzed key clinical research features for approved new drugs. Lawrence Liberti, Director of the D.K. Kim International Center for Regulatory Science and Associate Professor of the Department of Regulatory and Quality Sciences at the University of Southern California, emphasized on the important role that the centers of excellence of regulatory science in the U.S. can play in optimizing the collaboration among government, industry, and academia to foster innovation of pharmaceutical products. Mario Alanís Garza, Senior Advisor at the Center for Innovation in Regulatory Science (CIRS) and former General Director of International Affairs at the Mexico’s Health Regulatory Agency, shared experiences in regional cooperation internationally, providing important references for building a pharmaceutical regulatory system in the Guangdong-Hong Kong-Macau Greater Bay Area that meets international standards. Yap Sher Rine, Senior Principal Assistant Director of the Center of Product and Cosmetic Evaluation at the Malaysia’s National Pharmaceutical Regulatory Agency, introduced Malaysia’s regulatory framework for traditional medicine products and analyzed the current status and future directions of key regulatory functions. Marcília Baticy Fernandes, Head of the Department of Health Sciences, Environment, and Technology at the University of Santiago in Cape Verde (one of the Portuguese-speaking countries), introduced the use of traditional Chinese medicine in Cape Verde and related regulatory challenges.

The forum was moderated by Professor Hao Hu, Associate Professor Defang Ouyang, and Assistant Professor Li Chihua from ICMS. The thematic discussions were led by Yuanjia Hu (Director of CPRS), Carolina Oi Lam Ung (Deputy Director of CPRS), and Associate Professor Ying Bian from the Institute. Carolina Oi Lam Ung also concluded the meeting.

Other participating experts included Fu Chong Lam, Chief of the Division of Traditional Chinese Medicine at Government of Macao S.A.R. Pharmaceutical Administration Bureau; Yihan Yang, Head of Regulatory Science and Policy Research Department at the Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring; Jian Wang, Professor at Wuhan University; Lan Yao, Professor at Huazhong University of Science and Technology; Tingrui Pan, Professor at the University of Science and Technology of China; Yunfeng Lai, Associate Professor at Guangzhou University of Chinese Medicine; Yajuan Zhang from Tsinghua University; and Meng Xiangrui from Chengdu University of Traditional Chinese Medicine. Corporate representatives included Honghao Shi from BeiGene Ltd., Shen Xiao from Hasten Biopharmaceutical Co. Ltd., Junyi Ma from ZSHK Laboratories Ltd., Xuelun Feng from Nam Yue Natural Medicine Co. Ltd., Ying Huang from Guangzhou Pharmaceutical International (Macao) Qingzhou Pharmaceutical Factory, Choi Kun Ung from Macaufacture Medical Supplies Ltd., Wing Suet Chung from Hovione PharmaScience Ltd., Lok Kei Cheong from Cheong Kun Pain Reliever Oil, and Jianheng Li from the Traditional Chinese Medicine Department at Kiang Wu Hospital.

This forum connected experts and policymakers in pharmaceutical regulation from Macau with those from mainland China, the Greater Bay Area, Southeast Asia, Portuguese-speaking countries, and other nations. It continuously builds a platform for exchange and cooperation among industry, academia, research, and government to support innovative development in drug and medical device regulation.

UM holds the inaugural ‘Macau International Forum on Pharmaceutical Regulatory Science’

A group photo