#MedSafetyWeek: EU4Health Joint Actions ensuring the safety, quality and compliance of medicines and medical devices

#MedSafetyWeek is taking place from 3 to 9 November 2025. This annual campaign, which celebrates its 10^th anniversary this year, aims to increase worldwide reporting of suspected side effects of medicines.  

For one week, a wide range of stakeholders – from medicines regulators, international organisations and health authorities to national pharmacovigilance centres and pharmaceutical companies – join forces to promote this year’s campaign, focusing on how we can make medicines safer. 

In line with the theme, HaDEA is managing two Joint Actions funded under the EU4Health programme aiming to ensure the safety, quality and regulatory compliance of medicines and medical devices in Europe. 

EU4H11 (Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy) has been working to improve the quality and consistency of pharmaceutical inspections in the EU and the European Economic Area (EEA), harmonising Good Manufacturing Practices (GMP) standards and enhancing audit trainings. 

This Joint Action has achieved key outcomes such as: 

• A proposal for training and qualifications of GMP inspectors, addressing the lack of a harmonised and standardised approach, ultimately ensuring consistent inspector competence while strengthening trust among EU and EEA authorities; 

• A proposal for the Joint Audit Programme (JAP) audit checklist and its interpretation guide, which contributes to the prevention of falsified medicines from entering the legal supply chain, thereby securing the internal EU/EEA pharmaceutical market and ensuring the business continuity of each national competent authority and the EU/EEA inspectors’ network. 

JAMS 2.0 (Reinforced market surveillance of medical devices and in-vitro devices) has been working to enhance market surveillance of medical devices across the EU by harmonising approaches and strengthening collaboration between national competent authorities. This Joint Action has focused on data exchange, inspections, surveillance campaigns and training, ultimately aiming at ensuring that medical devices are safe, effective, and compliant with EU regulations. 

Among its key achievements, JAMS 2.0 has: 

• Created a template for manufacturers detailing all documentation requested for the evaluation campaign; 

• Developed a ‘best practice paper’ to identify and collate data for signal detection in pharmacovigilance, helping to facilitate a more harmonised approach to signal detection and the assessment of manufacturer incident reports by national competent authorities. 

Background 

EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe. HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and calls for tenders from 2021 to 2027.