New EMA guidance on the IRIS platform
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure This guide has been produced to help new users of IRIS to complete the prerequisite steps before accessing the platform. Most of these steps are independent from the IRIS
EMA develops a Concept Paper on the development of guidance concerning use of external controls for evidence generation in regulatory decision making
The European Medicines Agency (EMA) has published a Concept Paper on the Development of a Reflection Paper on the Use of External Controls for Evidence Generation in Regulatory Decision Making (Concept paper).
The Concept Paper recalls the current lack of specific regulatory guidance concerning the use of external controls to support regulatory decision making
Revision to EMA Alzheimer’s Trial Guideline
The European Medicines Agency Guidelines on the clinical investigation of medicines for the treatment of Alzheimer's Disease (AD) were last updated in 2018. The Agency has recently published a concept paper concerning future revision of these Guidelines.
The revisions are, in part, the result of recent advances in the field of AD
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.
EMA Unveils ERATO its new AI Tool improving Pharmacovigilance Signal Detection
Among the initiatives discussed by the European Medicines Agency (EMA) in its recently published annual report on 2024 activities was its new AI tool Enhanced Review of Abstracts with Transformer models (ERATO).
The purpose of ERATO is to reduce by an estimated 80% to 90% the roughly 200,000 abstracts the EMA Pharmacovigilance Office reviews every year. This could save more
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.