The European Medicines Agency (EMA) has launched a public consultation to collect input for a reflection paper on patient access to electronic product information (ePI). The ePI is the future electronic product information for medicines, and it is the outcome of a...
Animal research remains essential for medical progress, despite ongoing efforts to develop alternative methods. Following an initiative by the National Committee for the Protection of Animals Used for Scientific Purposes, the Italian Ministry of Health is promoting...
Following a public consultation period, the Regulation on Health Technology Assessment (HTA) has been officially published and entered into force. The new rules establish a permanent EU framework for the joint clinical assessment of health technologies, such as...
The European Medicines Agency (EMA) has recommended the approval of two medicines that could offer new therapeutic options for people living with rare and serious conditions. Duvyzat® has received a conditional marketing authorisation recommendation for the treatment...
The Clinical Trials Information System (CTIS) has officially been designated as a primary registry by the World Health Organization (WHO) within the International Clinical Trials Registry Platform (ICTRP). This recognition confirms that CTIS meets strict international...
The EMA (European Medicines Agency) “Reflection paper on the current regulatory testing requirements for human medicinal products and opportunities for implementation of the 3Rs” has been developed as a follow-up to the 2016 “Guideline on the principles of regulatory...
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...
On 11 March, the Commission proposed a new regulation, the Critical Medicines Act, to enhance the availability of critical medicines in the European Union (EU). This initiative complements other legislative proposals addressing medicine shortages, including the by...
On 1 January 2025, Regulation (EU) 2024/568 on fees and charges came into force. It affects the European Medicines Agency. Such law stipulates that scientific advice fees are waived for entities not engaged in economic activity, including academia. This exemption also...
The European Medicines Agency (EMA) has issued its first Qualification Opinion (QO) on an AI-based tool for clinical research. The tool, AIM-NASH, assists pathologists in analysing liver biopsies to assess the severity of MASH (Metabolic dysfunction-associated...
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