The European Medicines Agency (EMA) cooperates with a number of countries and organisations outside the European Union (EU) based on specific types of agreement, which enable the signatories to share confidential information or facilitate market access and achieve greater international harmonisation while protecting consumer safety.
EMA has formalised its working relations with a number of third-country regulators through bilateral confidentiality arrangements.
These arrangements enable the parties to exchange confidential information and provide a framework for regulatory cooperation. Their scope focusses on centrally authorised products, including marketing authorisation applications and referrals for human and veterinary medicines.
Switzerland and the World Health Organization (WHO) signed the most recent confidentiality arrangements with EMA in 2015.
The emphasis 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.
The Agency has standing confidentiality arrangements with:
- European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe
- United States
- World Health Organization (WHO)
The Agency can also establish ad-hoc confidentiality arrangements with international regulators to address specific public-health needs. These agreements have a limited scope and duration.
The EU has signed a number of mutual recognition agreements with third-country authorities concerning the conformity assessment of regulated products, which cover 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 harmonisation of compliance standards.
The EU has mutual recognition agreements with: