The Centre for Pharmaceutical Regulatory Sciences (CPRS) at the University of Macau (UM) held the “2025 Pharmaceutical Regulatory Science Workshop – From Regulatory Insights to Global Drug Development” at UM on 15 October. The workshop facilitated a meaningful exploration of pharmaceutical regulatory science across countries, and shared perspectives on the challenges and opportunities in drug development in diverse regions, including major emerging markets.

On behalf of Prof. Xin Chen, Director of ICMS, Prof. Jiahong Lu, Deputy Director (Research and Technology Transfer) of ICMS, noted in his opening remarks that Macao, with its historical ties to Portugal, serves as a vital gateway to Portuguese-speaking countries. The workshop’s focus on regulatory insights directly supports Macao’s pivotal role by fostering cross-cultural collaboration and regulatory harmonization, while advancing ICMS’s mission to transform centuries-old Traditional Chinese Medicine (TCM) wisdom into evidence-based therapeutics that meet rigorous international standards.

Dr. Zili Li, Board Member of Drug Information Association (DIA) and Food and Drug Administration (FDA) Alumni Association, and former Clinical Team Leader in the US FDA, shared his valuable experience and opinions on China’s biotech innovation. He suggested building a new drug development model to address unmet medical needs in emerging markets such as China. Throughout his more than 25-year career in global pharmaceutical regulation and drug development, Dr. Li has held significant global and regional positions at organizations such as the Merck & Co., Johnson & Johnson, and the Bill & Melinda Gates Foundation. Drawing on this experience, he provided the participants with an insider-level insight into the regulatory decision-making and risk-benefit regulatory judgments of both Eastern and Western authorities.

Dr. Antonio Barra Torres, former President-Director of Brazilian Health Regulatory Agency (ANVISA) and DIA Fellow, introduced the connection and collaboration between Brazil and China in the healthcare sector. He also shared in-depth insights on how global collaboration could promote Brazil’s biotech innovation through health and regulatory policy, which showed great market potential in Portuguese-speaking countries and further opportunities for collaboration and communication between China, Macao and Brazil.

After that, Prof. Yuanjia Hu, Director of CPRS, held a panel discussion with the above speakers to further discuss how TCM can be implemented in Portuguese-speaking countries and the translation of regulatory policies and decision-making into more effective global drug innovation strategies in emerging countries, thus supporting the delivery of safe and effective medicines.

This workshop attracted industry professionals, researchers and students from both Macao and the Greater Bay Area. Prof. Hao Hu, Ying Bian, Defang Ouyang, Jing Zhao and Jing Yuan of ICMS also attended the workshop.

A group photo

Dr. Zili Li

Dr. Antonio Barra Torres

Panel discussion