Steps to maximize the utilization of EU's specialized resources for expedited evaluations, working together, the European Medicines Agency (EMA) and the European Medicines Regulatory Network aim to increase the effectiveness of the EU's new drug assessment and approval procedures. With this initiative, the network's expert resources will be used more efficiently, applicant application dossiers will be better and more thorough from the start, and assessment procedures will be streamlined. The initiative's main goal is to hasten the availability of patient-centered, safe and efficient treatments.
One of the areas identified as needing improvement is the reliability of long-term planning for initial marketing authorisation applications (MAAs). This has been a recurrent problem for the network for many years, binding precious assessment resources and slowing down medicine approval times.
According to a recent report published by EMA:
In 2023, the percentage of MAAs submitted on time (i.e. as per the date indicated on the letter of intent from the applicant) was only 35%. This is in line with 2018-2022 data, which indicates that each year only 30-40% of expected MAAs are submitted on the date indicated in the letter of intent.
42% of companies seeking marketing authorisation in 2023 requested more time to respond to questions from EMA’s scientific committees during the assessment (also known as an ‘extended clock-stop’) because their data was not mature enough when it was submitted to EMA.
In 2023, the average duration of clock-stops for initial MAAs (198 days) was comparable to the average time of assessment (204 days). In 2022, the average clock-stop was longer (205 days) than the assessment time (196 days).
These challenges are being addressed by EMA and the Heads of Medicines Agencies (HMA) through a series of comprehensive measures.
A multi-stakeholder workshop took place on Wednesday, 25 September to discuss submission predictability and how it can be improved. Representatives from national competent authorities, industry and EMA discussed some of the possible reasons for poor submission predictability via a number of case studies. A report with further recommendations to industry is under preparation and presentations from the workshop will be published.
Read full article about other ongoing measures that aim to ensure the sustainability of the EU regulatory network at: Improving efficiency of approval process for new medicines in the EU | European Medicines Agency (EMA) (europa.eu)
