In line with Council Regulation 2015/496 amending the original Archives Regulation 354/83, the European Medicines Agency (EMA) made its first archival deposit at the Historical Archives of the European Union (HAEU) in Florence in October 2025. The deposit marks an important milestone in preserving the history of one of the earliest agencies of the European Union.
The newly accessible records shed light on the EMA’s early years, covering its creation, governance and management. The documents include files relating to the Agency’s establishment and role; press releases; correspondence between the Agency and National Competent Authorities; the outcomes of the first evaluations of medicinal products; and records on leadership within the European Medicines Management Board.
The files have been checked and inventoried and are now available for online consultation in the HAEU database, in accordance with the thirty-year rule.
About the European Medicines Agency
The European Medicines Agency was established in 1993 by Council Regulation (EEC) No 2309/93 of 22 July 1993, which laid down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and established a European Agency for the Evaluation of Medicinal Products. The EMA became operational in 1995 with the objective of harmonising the work of existing national medicines regulatory bodies. It was initially located in London, before being transferred to Amsterdam in 2019 following the United Kingdom’s withdrawal from the European Union.
The EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines across the European Union. Its work protects public and animal health in the EU and in the countries of the European Economic Area. Since the 2000s, the EMA has expanded its remit to include the regulation of medicinal products developed for the treatment of rare diseases, paediatric illnesses, as well as advanced-therapy and herbal medicines.
Photo: The European Medicines Agency in Amsterdam. Used with permission. © European Medicines Agency, 2024