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.
- 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
HMPWG Guidance documents on Safety
HMPWG General Guidance/Regulatory and Legal issues/Notice to Applicants
CTFG News and events
CTFG Key documents list
HMA/EMA Joint Big Data Steering Group Key documents
HMA/EMA Joint Big Data Steering Group Members and Representatives
HMA/EMA Joint Big Data Steering Group Introduction/Overview/Mandate
HMA leaflet 'Protecting and Promoting Public and Animal Health in Europe | pdf
Updated July 2019