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TFDA becomes the Associate Member of the ICMRA

【Update Date:2024-02-21unit:藥品組

In order to learn from other medicines regulatory authorities’ responding strategies on the current concerned issues, Taiwan Food and Drug Administration (TFDA) has submitted the expression of interest application letter to International Coalition of Medicines Regulatory Authorities (ICMRA) to become the Associate Member in 2023. After the decision made by the ICMRA Plenary Meeting, Taiwan Food and Drug Administration (TFDA), Chinese Taipei has officially become a part of the ICMRA community.

ICMRA is a voluntary-basis, executive level, international and non-political coalition of head of medicines regulatory authorities. ICMRA was established in 2013 and aims to support enhanced communication, information sharing, crisis response and address global regulatory science issues. ICMRA is currently consisted of 24 Full members (i.e., US FDA, EMA, MHLW/PMDA, MFDS, Health Canada, etc) and 15 Associate members (i.e., DKMA, ANMAT, SFDA, etc). The coalition now focus on issues related to innovation, Pharmaceutical Quality Knowledge Management System (PQKMS), public health emergency clinical trials, RWE and vaccine pharmacovigilance and jointly produce reflection paper and host workshops.

        In the future, TFDA will actively participate in all the ICMRA working groups and initiatives to deep dive into learning the trends of the current global regulatory issues and exchanging information on the health policy with other medicines regulatory authorities. Through joining the ICMRA will help TFDA better cope with all the challenges, construct the regulatory environment that harmonize with international standards and thus achieve the goal of continuous international collaboration.