EMA
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.
A new reflection paper from the European Medicines Agency marks a significant step forward in patient-centered drug development, as it aims to promote the systematic integration of patient experience data across all stages of the process.
The European Medicines Agency’s executive director Emer Cooke will remain in her post until April 2027, a shorter timeframe than the full five-year term for an executive director’s mandate at the agency, as she will be due to retire.
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.
A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.