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

more
modified 16/07/2024

This is a new custom box with content.
modified 16/07/2024

HMA Substances Validation Group Key documents
modified 12/07/2024

SAFE CT
modified 08/07/2024

HMPWG Public Consultation
modified 02/07/2024

HMPWG General Guidance/Regulatory and Legal issues/Notice to Applicants
modified 02/07/2024

HMPWG Reports
modified 02/07/2024

BEMA Programmes
modified 01/07/2024

CTCG Key documents list
modified 28/06/2024

CTCG Activities and achievements
modified 10/06/2024

DOWNLOADS