To promote regulatory convergence across the Asia-Pacific region and enhance the quality and efficiency of drug registration management and medical device regulatory science, the Taiwan FDA organized the 2025 APEC Good Registration Management (GRM) & Medical Devices (MD) Regulatory Science Center of Excellence (CoE) Workshop from August 26 to 28. This year’s workshop was endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC) as an official training program. The GRM session brought together nearly 20 experts from the European Medicines Agency (EMA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), the D.K. Kim International Center for Regulatory Science at the University of Southern California (USC), and experts from Taiwan, including the Center for Drug Evaluation (CDE), the Asia Partnership Conference of Pharmaceutical Associations (APAC), and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA). At least 70 participants from multiple APEC member economies, sharing best practices on good registration management and discussing topics such as accelerated approvals for medicines addressing unmet medical needs and combination products. The workshop emphasized interactive learning to foster collaboration and improve the overall efficiency of drug review and submission processes. The MD session featured experts from PMDA, the Japan Medical Imaging and Radiological Systems Industries Association (JIRA), and experts from Taiwan, including the CDE, Taiwan Drug Relief Foundation (TDRF), Industrial Technology Research Institute (ITRI), and Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter. A total of 34 participants were trained with a focus on the application of International Medical Device Regulators Forum (IMDRF) guidances. Through group discussions and case studies, participants explored the full life-cycle management of medical devices and exchanged practical experiences. Arrangements were also made for international regulators to visit a local medical device manufacturing facility to observe how the Taiwanese industry implements international standards. This demonstrates Taiwan’s commitment and achievements in promoting international regulatory harmonization. In 2025 workshop, participants came from 14 economies, including Singapore, Indonesia, Philippines, Vietnam, Malaysia, Hong Kong, Papua New Guinea, Chile, Peru, Brazil, Cuba, El Salvador, Oman, and Tanzania, fully reflecting Taiwan’s extensive influence in advancing regional cooperation and professional exchange. As an active APEC member, TFDA continues to drive capacity building and harmonized regulatory frameworks for pharmaceuticals and medical devices. Through the CoE platform, Taiwan is committed to improving submission quality, streamlining reviews, promoting life-cycle regulatory science, and empowering seed instructors—advancing regional convergence and contributing to better public health across the Asia-Pacific.