The European Medicines Agency (EMA) is inviting researchers and developers from academic and not-for-profit organisations to take part in a survey. The goal is to map current expertise and developments in medicines and scientific tools and better understand the...
A new clinical trial map is now accessible via the Clinical Trials Information System (CTIS) public website. Designed for patients and healthcare professionals, it provides real-time, comprehensive access to clinical trials across the European Union (EU), improving...
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...
A second public consultation is now open on the Technical Specification (TS) of the ICH M11 Clinical Electronic Structured Harmonised Protocol. This aims to ensure clinical trials protocols follow a standardised format and can be electronically exchanged in a...
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...
The Committee on Public Health (SANT) has launched a public consultation to gain a deeper understanding of the challenges faced by people living with rare diseases and to gather insights from those working in or involved with this field. Taking part is crucial as...
After two rounds of public consultations, the EMA adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which will enter into force on 1 July 2025. The guideline explains...
The GDPR introduces the concept of ‘pseudonymisation,’ highlighting it as a potential safeguard for ensuring compliance with data protection requirements. The EDPB guidelines clarify its definition, applicability, and benefits, explaining how it supports key GDPR...
We are pleased to announce a new publication in Frontiers in Medicine. It is titled “Effects of the Paediatric Regulation funding on the development of off-patent medicines in children”. The authors Lucia Ruggieri, Silvia Torretta, Viviana Giannuzzi, Adriana Ceci, and...
The update of the ICH E6 (R3) guideline on Good Clinical Practice (GCP) is currently in its final stages and is expected to come into force during 2025. Its final release will depend on the regulatory authorities of each country involved in the ICH. Since the first...
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