About HMA
The Heads of Medicines Agencies (HMA) is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area.
The HMA co-operates with the European Medicines Agency (EMA) and the European Commission in the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities.
The HMA is coordinated and supervised by a Management Group and it is supported by several Working Groups, covering specific areas of responsibility, and by a Permanent Secretariat.
Main Activities
The HMA:
- addresses key strategic issues for the network, such as the exchange of information, IT developments and sharing of best practices
- focuses on the development, co-ordination and consistency of the European medicines regulatory system
- ensures the most effective and efficient use of resources across the network. This includes developing and overseeing arrangements for work-sharing
- co-ordinates the mutual recognition (MRP) and decentralised procedures (DCP).
Member agencies support the network by providing high-quality professional and scientific resources to all areas of medicines regulation including centralised, MRP, DCP and national procedures.
ABOUT HMA | RECENTLY PUBLISHED
Warning about sharp rise in illegal medicines sold in the EU
modified 03/09/2025
Archive of Working Groups
modified 02/09/2025
Periodic Safety Update Reporting (PSUR) - Synchronisation and Work-sharing
modified 01/09/2025
Periodic Safety Update Reporting (PSUR) - Synchronisation and Work-sharing
modified 01/09/2025
ARCHIVE
modified 01/09/2025
CTCG Key documents list
modified 04/08/2025
Guideline and recommendations for transparency
modified 31/07/2025
Working Groups Veterinary
modified 25/07/2025
Working Groups Human
modified 25/07/2025
Working Groups Joint
modified 25/07/2025
DOWNLOADS
HMA leaflet 'Protecting and Promoting Public and Animal Health in Europe | pdf
Updated July 2019