Invited by the Centre for Pharmaceutical Regulatory Sciences, University of Macau (CPRS), Dr. Mann Fung, the President of MCF Consulting and an adjunct professor at the Peking University Clinical Research Institute, delivered a seminar titled “Charting New Territories: Evolution of FDA Regulations, Global Interactions, and the Next Wave of Medical Breakthroughs” to ICMS professors, researchers and students on September 16, 2024.

In this seminar, Dr Fung introduced the historical evolution of the regulations set forth by the FDA concerning pharmaceuticals and medical devices. The seminar explored the current policies that govern real-time practices within the industry, as well as the future directions and prospects of FDA regulations. Dr. Fung had previously served as a Medical Reviewer and Team Leader at the FDA’s Center for Drug Evaluation and Research (CDER) and had a rich background in the biopharma sector from his career at Eli Lilly, J&J, and Tavotek. With Dr. Fung’s extensive experience in both the regulatory and industry sectors, he provided his unique insights and understanding of the challenges and opportunities that existed within this dynamic field from a dual perspective as both a regulator and a biopharma professional. Additionally, Dr. Fung highlighted the latest trends in FDA approvals for groundbreaking technologies, including Brain-Machine Interfaces, Surgical Robotics, as well as innovative therapies such as stem cell therapy and gene editing/gene therapy. Furthermore, Dr. Fung discussed the FDA’s interactions with global regulatory bodies such as the EMA, PMDA, and ICH. At the end of the seminar, Dr. Fung provided his opinion on the unique roles that Macau could develop in the pharmaceutical and regulatory sectors in engaging with the FDA. Dr. Fung also discussed with the participants the different approval pathways and concerns in the FDA for new drugs and medical devices, as well as applications and attitudes towards novel technologies such as Artificial Intelligence.

During the visit, Dr. Fung was warmly received by Prof. Hu Yuanjia, the director of the Centre for Pharmaceutical Regulatory Sciences, University of Macau. Both parties exchanged experiences and ideas in research and knowledge translation, capacity building and collaboration.

Group photo of the seminar “Charting New Territories: Evolution of FDA Regulations, Global Interactions, and the Next Wave of Medical Breakthroughs”

Dr Mann Fung