The European Medicines Agency (EMA) has opened a public consultation on a new “Reflection paper on non-human primates (NHPs) in safety testing of human medicinal products and opportunities for 3Rs implementation”. The aim of this Reflection Paper is to provide an...
On 13 November, the European Medicines Agency (EMA) announced the Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending marketing authorisation for Etuvetidigene autotemcel (Waskyra®). This is an ex vivo hematopoietic stem cell gene...
Fondazione Gianni Benzi took part, from 4 to 7 November 2025, in the EP PerMed Implementation School on Personalised Medicine – Data-driven Research and Implementation, held in Zaragoza at the CIBA – Aragon Health Sciences Institute. The School, organised by the EP...
Two new reports highlight how Artificial Intelligence (AI) is reshaping healthcare and medicine development across Europe, offering major opportunities but also raising key challenges. The Study on the Deployment of AI in Healthcare (Final Report) finds that European...
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...
On World Patient Safety Day 2025, the World Health Organization (WHO) is urging countries to invest in safe, high-quality care for children and newborns, under the campaign theme “Patient safety from the start!”. Unsafe care remains a major but preventable cause of...
The European Medicines Agency (EMA) has recommended the conditional approval of Zemcelpro®, a promising new stem cell-based Advanced Therapy Medicinal Product (ATMP) designed to treat adults with haematological malignancies, including leukaemia, lymphoma, myeloma, and...
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...
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