On 10 October the European Medicine Agency has published the “ICH M14 Guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise Real-World Data for safety assessment of medicines” which will come into...
The European Medicines Agency (EMA), together with nine EU National Competent Authorities (NCAs), has published a comprehensive report on the EU Repurposing Pilot initiated in 2021 to facilitate new therapeutic indications for authorised off-patent medicines. This...
The European Medicines Agency (EMA) has opened a public consultation on the “Reflection paper on patient experience data”. Patients experience data provide valuable insight on their preferences on treatments or outcomes to medicines regulators and other...
The European Medicines Agency (EMA) has opened a public consultation on the “Reflection Paper on the use of external controls for evidence generation in regulatory decision-making”. Recent developments in data availability and statistical/pharmacoepidemiological...
The Heads of Medicines Agencies (HMA), in collaboration with the European Medicines Agency (EMA), has released the third report on the integration of Real-World Evidence (RWE) in regulatory decision-making. From February 2024 to February 2025, the number of RWE...
The Council for International Organizations of Medical Sciences (CIOMS) has released a new report offering valuable insights into the methodologies used to assess the benefit-risk (BR) balance of medicinal products. Establishing a favourable BR profile is essential...
On 11 February 2025, the European Data Protection Board (EDPB) has released a new statement outlining key principles and concerns regarding age assurance measures on online platforms. The document provides guidance for organisations implementing age verification and...
Following public consultation, the EMA has finally published its Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes, providing clearer guidance on regulatory expectations and methodological...
We are pleased to announce that our researcher, Mrs. Annalisa Landi, recently give a talk entitled "ELSI and Data Protection for Rare Diseases Data". This insightful presentation was part of the HemaFAIR project, which aims to promote the application of FAIR...
On 5 March 2025, the European Union officially published the European Health Data Space (EHDS) Regulation (Regulation (EU) 2025/327), marking a significant step towards a unified framework for electronic health data across member states. The Regulation establishes a...
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