In order to improve the regulatory convergence and to enhance the quality and efficiency of the review and submission of medicinal products in the APEC region, the Taiwan TFDA hosts the “Good Registration Management Regulatory Science Center of Excellence Workshop (GRM CoE)” from August 29 to September 15.  This workshop includes a series of digital courses and live webinars delivered by 19 regulatory officials, scholars and industry experts from various countries to over 100 trainees from 11 APEC economies.    These trainees are expected to disseminate the GRM concept and to promote the Good Review and Submission Practice in the APEC region.

This workshop is approved and endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC).  The lecturers include regulatory and industry experts from the Australian Department of Health, the EMA, the PMDA, the GHC, the Temple University School of Pharmacy, the CDE and the IRPMA.  They are going to share their experiences on Good Review and Submission and address special issues such as the regulatory decision making for orphan drugs, the application of RWD/RWE and the collaboration on joint drug review.   The trainees are mainly drug regulatory affairs (RA) personnel from Japan, Malaysia, Philippines, Hong Kong, Vietnam, Columbia, Peru, Indonesia, Russia, Thailand and Taiwan.

The TFDA has long involved in the APEC RHSC activities and is a long-term campaigner for the GRM concept and the regional regulatory convergence.   The TFDA will continue to organize GRM-related trainings so as to increase the review capacity and efficiency and to encourage international communication.  The ultimate goal is to improve the well-being of the people around the world.

 【2022-08-29 / TFDA】