Whether it is blood pressure medication, vaccines or other essential medicines – their safety and quality must be guaranteed at all times. Medicines inspections play a central role in this by ensuring that medicines are manufactured, stored and transported safely and to a high standard. This is precisely where the EU4H11 Joint Action project came in, which successfully concluded on 30 April 2026 after a three-and-a-half-year run. As part of the project, 40 medicines inspectorates across the European Economic Area (EEA) worked more closely together. The aim was to harmonise inspections more closely across Europe, provide targeted training for inspectors and improve cooperation between authorities. As medicines are now often produced globally, uniform standards and international cooperation are therefore crucial to effectively protect patients.

Results at a glance

• Conduct of 36 Europe-wide harmonisation audits by medicines inspectorates
• Support for more than 500 training activities for inspectors
• 28 joint inspections to exchange knowledge and experience
• Establishment and expansion of EU training and quality standards
• Close coordination with international partner authorities

Austria as a driving force

These measures strengthen the European control system, avoid duplication and ensure uniformly high standards for medicinal products. Austria played a central role in this project: the inspectors from AGES’s Medicines Market Surveillance Unit, acting on behalf of the Federal Office for Safety in Healthcare (BASG), coordinated the Europe-wide project. A follow-up project with an expanded focus on the exchange of regulatory information is also already in the planning stage. Outlook: Subject to a positive assessment, the next project could start in autumn 2026 and further deepen cooperation between European medicines regulatory authorities. This pursues a clear objective: the safety and quality of medicines for patients across Europe.