To promote the regulatory convergence and enhance the efficiency and quality of the registration of the medicinal products among Asia-Pacific region, Taiwan Food and Drug Administration (TFDA) is hosting the ‘2023 APEC Good Registration Management (GRM) Center of Excellence (CoE) Workshop’ from September 6th to September 8th. TFDA has invited 20 experts from overseas and local regulatory authorities, the pharmaceutical industries and the academia to provide trainings for trainees. 80 trainees from 9 APEC economies and from the government, academia and industries are trained as the seed lecturers to promote the concept of Good Registration Management (GRM).
This workshop is endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC). TFDA has invited experts from U.S. FDA, EMA, PMDA, International Center for Regulatory Science (University of Southern California), CDE and IRPMA etc., to share with the trainees about the concept, principles and cases of implementing GRM. To foster the experience sharing with each other, TFDA also invited reviewers and applicants from the USA, Malaysia, Philippines, Singapore, Indonesia, Thailand, Vietnam, Papua New Guinea, Pakistan, Botswana and Taiwan to participate in the workshop.
TFDA has been actively engaging in the APEC RHSC activities. Since 2016, 70-110 trainees have been trained through the workshop annually. Through the workshop, it will not only contribute to promote the concept of GRM, but also improve the efficiency of drug review and submission. TFDA will continue to host the GRM workshops and provide training programs to strengthen the capacity building and international collaboration for achieving the goal of well-being and health for all.