Confidentially Agreement Signed Between European Union and Republic of Korea Regulatory Bodies

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The European Medicines Association (EMA) and the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) have signed a working agreement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea in order to share confidential information on medical and medicinal products. This partnership will build on the close cooperation fostered between the two regulatory authorities during the COVID-19 pandemic and is intended as a step toward mutual recognition and regulatory harmonization as they work to improve human and animal health. The agreement also builds on the previously established ad-hoc arrangement, which ensured the exchange of medicinal information used for diagnosing, preventing, and treating COVID-19 and related infectious diseases.

The arrangement, which came into effect on Apr. 25, 2024, will allow participants to exchange sensitive information on medicinal products as part of their regulatory and scientific processes. This will include confidential information about the safety, quality, and efficacy of human medicines which have been authorized or are under evaluation, as well as information on inspections, regulatory guidance, and legislation. These types of confidentiality agreements can allow for faster exchanges of information on quickly emerging global issues, such as medicine shortages, quality concerns, and safety questions.These type of confidentiality arrangements, EMA said in a press release, “are the cornerstone of global cooperation” (1). This arrangement between the EU and Korea is valid for an indefinite period and will not need a renewal.

In its International Agreements page, EMA states that it has formalized its working relations with a number of third-country regulators through bilateral confidentiality agreements, which allows the parties to exchange confidential information and provide a framework for regulatory cooperation. “The emphasis,” the agency states, “is on exchange of information concerning regulatory guidance, legislation and non-public information on products, as well as safety information including adverse reactions, good manufacturing practice (GMP) and good clinical practice (GCP) inspection findings” (2).

EMA has listed the countries it has standing confidentiality agreements with, which are: Australia, Brazil, Canada, Japan, Switzerland, the United States, and now the Republic of Korea. It also has this agreement with the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe, and the World Health Organization (WHO). The agency states that it can also establish ad-hoc confidentially arrangements with international regulators to address specific public-health needs; such agreements have a limited scope and duration.

The agency also has signed several mutual recognition agreements on the conformity assessment of regulated products, which covers the mutual recognition of GMP compliance for human and veterinary medicines. These agreements aim to “facilitate market access while protecting consumer safety and encourage greater international harmonization of compliance standards” (2). EMA has signed mutual recognition agreements with Australia, Canada, Japan, New Zealand, Switzerland, and the United States. It has also signed this agreement with Israel, though the agency notes the agreement is on conformity assessment and acceptance of industrial products.

References

1. EMA, Confidentiality Arrangement between the EU and the Republic of Korea. ema.europa.eu. Apr. 26, 2024.
2. EMA, International Agreements. ema.europa.eu/en/partners-networks/international-activities/international-agreements (accessed Apr. 26, 2024).