The World Health Organization (WHO) has launched new guidance to support the prioritisation of health research, recognizing the need to make strategic choices when limited resources mean not all projects can be pursued. Ethics plays a fundamental role in this process,...
On 19 June, the World Health Organization (WHO) released its first-ever global guideline on the management of sickle cell disease (SCD) during pregnancy, addressing a critical and growing health challenge that can have life-threatening consequences for both women and...
The Italian Medicines Agency (AIFA) has published the 2025 Independent Research Call dedicated to rare diseases. The initiative aims to support studies on low-prevalence conditions that often lack commercial research investment due to limited market potential. The...
The European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA), has published a joint workplan "Data and AI in medicines regulation to 2028" to harness data and tools to drive research, support regulatory decisions, and accelerate access to...
The European Medicines Agency (EMA) has published a new draft guideline offering key recommendations for the inclusion and retention of pregnant and breastfeeding individuals in clinical trials. This initiative aims to support the generation of robust clinical data in...
The European Medicines Agency (EMA) has opened a public consultation on the “Reflection Paper on Data Recommendations for Herbal Medicinal Products and Traditional Herbal Medicinal Products Used in Children and Adolescents”. Herbal medicinal products (HMPs) and...
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...
A new Standard Operating Procedure (SOP) titled “Validation, Publication, and Maintenance of Real-World Data Sources and Studies in the HMA-EMA RWD Catalogues” (SOP/TDA/3543) has been published by the European Medicines Agency (EMA). This SOP outlines the systematic...
The European Commission has opened a public consultation to gather feedback on the implementation of the AI Act's rules concerning high-risk AI systems. The aim is to collect practical examples, clarify open questions, and inform upcoming Commission guidelines on the...
24 May 2025, Geneva Switzerland The Seventy-eighth World Health Assembly (WHA78) adopted a landmark resolution to formally recognise rare diseases as a global health priority. The resolution aims to improve equity and inclusion for more than 300 million people living...
Recent posts in News