Do not go gentle into that good night, old age should burn and rave at close of day; Rage, rage against the dying of the light, though wise men at their end know dark is right, because their words had forked no lightning they, do not go gentle into that good night.
Korea joins Europe in landmark joint review of biopharmaceuticals
A promotional poster highlighting a joint pharmaceutical review between the National Institute of Food and Drug Safety Evaluation and the European Medicines Agency. Courtesy of National Institute of Food and Drug Safety Evaluation
By Jhoo Dong-chan
In a milestone move toward cross-border regulatory alignment, Korea’s drug safety watchdog said Wednesday that it completed its first international joint review of a biopharmaceutical product alongside European and global regulators.
The breakthrough is poised to substantially ease the regulatory bottleneck for multinational pharmaceutical companies seeking multimarket approvals.
The Ministry of Food and Drug Safety said that its evaluation arm, the National Institute of Food and Drug Safety Evaluation, concluded a simultaneous scientific assessment under the "Opening our Procedures at EMA to Non-EU authorities" (OPEN) framework. Spearheaded by the European Medicines Agency, the initiative brought together regulatory experts from Korea, Switzerland and the World Health Organization to jointly review a changes-to-permits application for a recombinant biological medicine.
Launched initially as a pilot in 2020 to accelerate the evaluation of COVID-19 therapeutics and vaccines, the OPEN program operates by standardizing evaluation requirements across participating countries. Historically, drug manufacturers were bogged down by localized requests, forcing them to construct separate, highly customized technical dossiers for every sovereign jurisdiction. Under this joint framework, however, application requirements are completely uniform.
The collaborative process kicked off in February, culminating in a critical online review session hosted by the EMA on April 15, where national regulators harmonized their findings. While each authority preserves its independent scientific and sovereign jurisdiction to issue final approvals, the consensus-driven blueprint enables companies to leverage a singular data package across multiple markets, sharply optimizing predictability and slashing compliance burdens.
For Korea, the successful integration into the OPEN framework serves as an institutional validation of its domestic medical oversight, following its inclusion in the WHO Listed Authorities in 2023. Regulatory officials stated they plan to expand joint assessments incrementally to assist domestic biotech firms navigating highly competitive foreign markets.
This article was published with the assistance of generative AI and edited by The Korea Times.