The Korean Research-based Pharma Industry Association (KRPIA) has welcomed the recent agreement between the Ministry of Food and Drug Safety of Korea, the EU Directorate-General for Health and Food Safety (DG SANTE), and the European Medicines Agency (EMA) to strengthen the exchange of confidential information on medical and medicinal products.

Last Thursday, the MFDS signed a “confidentiality agreement for exchanging information on medicines between Korea and the EU” with DG SANTE and the EMA.

As a result, the agencies will be able to exchange confidential information held by each organization, including information related to drug safety, efficacy, and quality, including licenses and clinical trial approvals, information collected, monitored, and analyzed, such as adverse events and risk information, regulatory policies for marketed drugs, and fact-finding, recall and risk assessment.

The DG SANTE is the European Commission's agency in charge of healthcare, food safety, public health, and animal health. The EMA evaluates and supervises all medicines and medical devices used in the EU.

"The signing of this agreement by the MFDS will positively impact the strengthening of the safety management of domestic medicines through active regulatory diplomacy and increasing global confidence in the quality of domestic drug regulation," KRPIA said.

The association said, evaluating the accord's significance, that the signing of this agreement paves the way for MFDS, together with the DG SANTE and the EMA, to pursue Mutual Recognition Agreements (MRAs) based on inter-agency trust in various fields, including medical products.

"In a diverse and rapidly changing international environment, the expansion of such global regulatory cooperation infrastructure is expected to help domestic medical products enter overseas markets, as well as improve access to globally innovative new drugs for Korean patients," the KRPIA added.