To promote regulatory convergence and enhance the efficiency and quality of the registration of medicinal products among the Asia-Pacific region, Taiwan Food and Drug Administration (TFDA) announces the hosting of the “2024 APEC Good Registration Management (GRM) Center of Excellence (CoE) Workshop”, scheduled from September 3^rd to September 5^th, 2024. This workshop brings together nearly 20 experts from local and international regulatory authorities, academia, and industry experts to provide comprehensive training to more than 80 participants from 9 APEC member economies. The aim is to disseminate and implement the GRM concept and promote regional regulatory convergence.

Endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC), the workshop features prominent experts from various countries, including the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the D. K. Kim International Center for Regulatory Science at the University of Southern California (USC), the Center for Drug Evaluation (CDE), the Asia Partnership Conference of Pharmaceutical Associations (APAC), and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA). These experts share their knowledge on GRM regulations and practical experiences, addressing specific topics such as benefit-risk assessment in regulatory decision-making for market authorization of medicinal products and conducting reviews in regenerative medicine. To foster experience sharing, the workshop also invites regulatory affair related participants from the government, academia, and industries across non-APEC and APEC member economies, including United States, Indonesia, Malaysia, Thailand, the Philippines, Singapore, Vietnam, South Korea and Chinese Taipei. Through the exchange of expertise and knowledge, the workshop aims to enhance cooperation between nations and improve the overall efficiency of medicinal product review and submission processes.

TFDA has long been engaged in APEC RHSC activities. By conducting regulatory training programs, TFDA aim to build capacity, foster international collaboration, and actively promote regulatory convergence and the GRM concept. These efforts continually contribute to improving the quality and efficiency of medicinal product review and submission, ultimately bringing greater health benefits to the public.