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 ‘2022 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence (CoE) Workshop’ from August 29th to September 15th. There are online self-learning courses and webinars in this year’s workshop and TFDA has invited 19 experts from overseas and local regulatory authorities, the pharmaceutical industries and the academia to provide trainings to more than 100 trainees from 11 APEC economies. Via this workshop, we hope to disseminate the GRM concept and further promote the Good Review and Submission Practice. 

 

     This workshop is endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC). TFDA has invited expert from Australian Department of Health, EMA, PMDA, Temple university of Pharmacy, CDE and IRPMA etc, to share with the trainees about the concept, principles and cases of implementing GRM. Moreover, this workshop would also discuss about the regulatory decision-making of orphan drugs, application of RWD/RWE and the review collaboration programs like ACCESS work-sharing and Project Orbis. 

 

     TFDA has been actively engaging in the APEC RHSC activities to promote the regulatory convergence and GRM concept. We will continue to host GRM workshops and training programs to strengthen the capacity building and international collaboration to benefit the well-being and health of the people.