The EU medicines regulatory network

The European Commission, the European Medicines Agency and the national authorities of the European Economic Area form one regulatory network for medicines in the EU. This branch covers that network, and its parts divide by the side of its work: the framework and strategies it works under and how they change, its action on medicine shortages, and its cooperation with regulators, agencies and organisations outside it. It leaves how far a regulation, a guidance and a guideline bind a document, and where national and regional requirements still diverge, to the rest of the regulatory framework; the procedures an application runs through to applications and authorisation procedures; the agency's work on real-world evidence to real-world evidence; and its work on artificial intelligence to artificial intelligence in law and regulation.

• What changed in the EU framework for medicines — the overhaul of the EU pharmaceutical legislation agreed in December 2025, from its simpler regulatory environment, support for innovation and supply obligations to its environmental and antimicrobial measures and its formal approval, the lessons of the network's COVID-19 response, and the network's strategies from the road map to 2015 to the strategy to 2028
• How the EU regulatory network acts on medicine shortages — the Medicines Shortages Steering Group, the solidarity mechanism and the shortages toolkit, the European Shortages Monitoring Platform, the Union list of critical medicines, the recommendations that strengthen the supply chains of listed medicines, and the supply chain of anti-D immunoglobulins
• How the European medicines network cooperates with other agencies and regulators — the International Coalition of Medicines Regulatory Authorities, the network's designation as a WHO Listed Authority and a decade of collaboration with the WHO, support for the African Medicines Agency, the One Health framework with the other EU agencies, and cooperation during health emergencies