EMA

The European Medicines Agency wants to develop a structured framework for non-clinical proof-of-concept studies in pediatric oncology.

The European Medicines Agency has requested updated safety warnings for Ixchiq’s product information after a case of aseptic meningitis was reported in a healthy young adult.

Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.

The European Medicines Agency’s review of its stepwise pediatric investigation plan pilot, which allows sponsors in justified cases to finalize core study details later in development, found that the approach was both feasible and valuable in supporting complex pediatric drug development programs.

The European Medicines Agency has formally begun the process of recruiting its next executive director, as EMA head Emer Cooke, prepares to retire in 2027.

Several orphan drugs, including SOBI’s emapalumab, Merck KGaA’s pimicotinib and Percigen’s zopapogene imadenovec, are now under review for potential pan-EU marketing authorization by the European Medicines Agency.

A marketing authorization application for another AstraZeneca product – its orphan drug candidate anselamimab – is now also under review in the EU.

The European Medicines Agency says drug companies can cut through the noise of irrelevant reports when searching for pregnancy-related adverse events about their products by adopting more precise identification methods.

The EMA has voted in favor of EU approval for five new products, including treatments for a rare, life‑threatening genetic disorder and for non‑cirrhotic MASH, and has also recommended reversing its earlier rejection of an orphan drug for chronic graft‑versus‑host disease.

The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.

The European Medicines Agency has not “always fared favorably” compared to other countries such as the US when it comes to drug approval timelines, but the reform of the EU pharma legislation is a key opportunity to “think out of the box,” says the agency’s head of therapeutics areas.

Scientific advances in pharmacogenomics have prompted the European Medicines Agency to propose revisions to its existing guideline to ensure its continued relevance and applicability.

The standard baseline of regulatory data protection will remain at eight years under the new pharma package, while market protection will drop to a year as standard. However, innovative products that fulfil certain criteria could get up to 11 years of market exclusivity.

The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.

A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.

EU drug regulators are taking steps to strengthen their assessment capacity by widening access to specialists from outside the EU/EEA.

The European Medicines Agency says it is speeding up its review of drug marketing applications through initiatives that restrict requests from companies for additional response time and minimize unnecessary questions from the assessors.

Finalized EU pharmaceutical legislation must ensure that patients are fairly represented in regulatory decision making, according to patient and industry experts.

A new EU study will assess the potential of existing Duchenne muscular dystrophy patient registries and other real-world data sources to address regulatory questions for emerging therapies.

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.