The Ministry of Food and Drug Safety has been elected for the first time to the executive committee of the International Coalition of Medicines Regulatory Authorities (ICMRA), the body that sets policy direction for the world's major drug regulators. Over the next three years, the ministry will help shape global drug regulatory strategy alongside the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
The ministry said on the 3rd that South Korea has joined the ICMRA executive committee for a term running from this year through 2029. ICMRA is a head-of-agency level international forum bringing together drug regulators from 40 countries to discuss public health issues and regulatory cooperation. South Korea joined as a founding member in 2013 but has never before sat on the executive committee.
The executive committee is the coalition's core decision-making body, setting regulatory cooperation strategy and priorities and determining how working groups operate and what goes on the summit agenda. The new committee comprises 13 regulatory agencies from 11 countries, including chair country Australia, South Korea, the United States, the European Union, Japan, Britain and Canada.
The ministry plans to put forward the use of artificial intelligence in drug regulation, wider cross-border joint reviews and faster introduction of innovative new drugs as key agenda items. That gives South Korea a channel to reflect its own regulatory experience and positions from the earliest stages of discussions that shape global standards.
Seoul will host the ICMRA summit and general assembly for the first time in November. Heads of major drug regulators from 40 countries, including the United States, the EU and Australia, are expected to attend and discuss regulatory issues such as AI and the direction of cross-border cooperation.
"This means international confidence in our regulatory capabilities has risen," Minister of Food and Drug Safety Oh Yu-kyoung said. "We will expand our role in global regulatory discussions."
