Republic of Korea
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:
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