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TFDA hosts 2021 APEC Good Registration Management Regulatory Science Center of Excellence (CoE) Workshop

【Update Date:2021-08-24unit:藥品組

To promote the efficiency and efficacy of the medicinal products’ registration process and enhance the regulatory convergence among the Asia-Pacific region, Taiwan Food and Drug Administration (TFDA) is hosting the ‘2021 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence (CoE) Workshop’ from August 24th to September 16th. There are online self-learning courses and videoconferences in this year’s workshop and TFDA has invited 17 experts from overseas and local regulatory authorities, the pharmaceutical industries and the academia to deliver trainings to more than 70 trainees from 14 economies. We hope through the workshop and the training programs, these trainees could help promote the GRM, Good Review Practice and Good Submission Practice concept.

This workshop is endorsed by the APEC Life Science Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC). TFDA has invited experts from TGA, EMA, PMDA, Temple University of Pharmacy, APAC and IRPMA to share with the trainees about the principles and cases implemented the GRM concept. In addition, the workshop would further discuss about the regulatory agility and adjustment under the COVID-19 pandemic and the considerations of the application of RWD/RWE in the regulatory decision-making.

APEC is one of the most important multilateral official economic cooperation forums and TFDA has been actively engaging in the APEC LSIF-RHSC to promote the regulatory convergence. We will continue to convene CoE workshops and training activities to promote the implementation of the GRM concept and strengthen the capacity building and regulatory harmonization in order to benefit the well-being and health of the people.