EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.
New Guidance Concerning Radiopharmaceuticals Supply Chain
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have published Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals.
Medicines and Healthcare products Regulatory Agency fee increases
The Medicines and Healthcare products Regulatory Agency (MHRA) has increased fees in a number of areas by an average of 8%. The fees entered into application on April 1, 2025.
EMA Updates and Strengthens Policy on Conflicts of Interest
The European Medicines Agency (EMA) has recently published an update to the Agency’s Policy on conflicts of interests of members of scientific committees and experts.