Republic of Korea

The European Commission's Directorate-General for Health and Food Safety (DG-SANTE) and the European Medicines Agency (EMA) have in place a confidentiality arrangement with the Ministry of Food and Drug Safety of the Republic of Korea since 2024.

The arrangement enables exchange of confidential information on medical and medicinal products between the EU and Korean authorities, as part of their regulatory and scientific processes.

It is a significant step towards mutual recognition and regulatory harmonisation between both regions.

The confidentiality arrangement is in effect as of 25 April 2024. 

Confidentiality arrangement

The arrangement is valid for an indefinite period of time, unless terminated by either party.

In line with this arrangement, EMA and the Ministry of Food and Drug Safety of the Republic of Korea can exchange information in the following areas:

• Medicinal products regulation to ensure safety, efficacy and quality, including activities related to licensing, authorisation of clinical trials and policy-making
• Monitoring compliance, such as pharmacovigilance and benefit-risk assessment
• Compliance and enforcement activities, including inspections, investigations and risk assessment

Parties can extend the exchange of information to other areas of activity.

A working arrangement document is available:

Working arrangement between the Ministry of Food and Drug Safety of the Republic of Korea and the Directorate-General for Health and Food Safety of the European Commission and EMA for the Exchange of Non-Public Information on Medicinal Products