This new partnership between the two regulatory authorities is an important step towards mutual recognition and regulatory harmonisation to improve human and animal health. The confidentiality arrangement builds on the close cooperation with MFDS during the COVID-19 pandemic and the establishment of an ad-hoc arrangement which ensured the exchange of information on medicines used for the diagnosis, prevention, and treatment of COVID-19 and related infectious diseases.
The arrangement allows its participants to exchange sensitive information about medicinal products as part of their regulatory and scientific processes. This includes confidential information on the safety, quality and efficacy of human medicines (already authorised or under evaluation) as well as information on inspections, regulatory guidance and legislation.
Confidentiality arrangements of this type contribute to timely information exchanges on fast emerging issues with global impact, such as shortages of medicines, quality concerns or safety questions and are the cornerstone of global cooperation.
The confidentiality arrangement, which came into effect on 25 April 2024, is valid for an indefinite period and does not require a renewal. It provides the framework for the European Union and the Korean authorities to further develop their regulatory cooperation.