Korea joins Europe in landmark joint review of biopharmaceuticals

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,