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The European Medicines Agency (EMA) and South Korea's Ministry of Food and Drug Safety have completed their first joint international review of a pharmaceutical product. Domestic companies will be relieved of the burden of submitting different sets of documents to European and Korean regulators, while the ministry is seen as having once again earned recognition for its global-level regulatory capabilities through the review.
The Ministry of Food and Drug Safety announced on the 17th that it had completed a joint review of a variation application for a biopharmaceutical through the EMA-led "Opening our procedures to non-EU authorities (OPEN)" program. It marks the first official case in which Europe and South Korea jointly reviewed the same product and reached a final result.
The OPEN program is a system in which the EMA jointly evaluates specific pharmaceuticals together with overseas regulators. It began as a pilot project in 2020 to facilitate cooperation on the evaluation of COVID-19 vaccines and treatments. Its scope has since expanded to include treatments for antibiotic resistance, drugs in short supply, priority medicines (PRIME), medicines addressing public health emergencies, and variation applications.
The ministry signed a confidentiality agreement with the EMA in April 2024 and has officially participated in the OPEN program since June of that year. Because joint reviews are conducted only after a company applies to participate, this case was the first such application. A ministry official explained, "Companies must apply to both the EMA and the ministry for a joint review," adding, "The first joint review application was received in February this year, and the process proceeded."
This joint review is expected to ease the burden on companies arising from differences in review standards across countries. Previously, the supplementary materials required by each country's regulator differed, forcing companies to prepare separate documents, but in a joint review the same supplementary requirements are presented. For companies, the ability to submit identical materials to both Korean and European regulators significantly reduces the burden of document preparation and improves the predictability of reviews.
A ministry official said, "During the joint review process, the EMA and each country's regulator coordinate supplementary requirements through meetings," adding, "Companies receive the same supplementary requests and can submit the same materials, which offers a major advantage in terms of document preparation."
The ministry plans to gradually expand the scope of joint reviews to support the global expansion of domestic pharmaceutical and biotech firms. A ministry official emphasized, "Building on this case, we plan to further expand joint reviews between regulators and international regulatory harmonization," adding, "We will actively support the overseas expansion and rapid supply of domestically developed pharmaceuticals."
