The European Medicines Agency (EMA) and the European Medicines Regulatory Network are working on a new initiative to further improve the efficiency of the evaluation and approval processes for new medicines in the European Union.
The initiative aims to better manage the use of the network’s expert resources, streamline evaluation processes and encourage applicants to produce better and more complete application files at the time of initial submission. The general objective of the initiative is to accelerate the availability of safe and effective treatments for patients.
One of the areas identified as requiring improvement is the reliability of long-term planning for initial requests for marketing authorization (MAA). This has been a recurring problem for the network for many years, tying up valuable evaluation resources and delaying drug approval timelines.
According to a recent report published by the EMA, in 2023, the percentage of marketing authorization applications submitted on time was only 35%. This coincides with data from 2018 to 2022, which indicates that each year only 30-40% of applications the envisaged MAs are filed on the date indicated in the letter of intent.
Similarly, 42% of companies seeking marketing authorization in 2023 requested more time to answer questions from the EMA’s scientific committees during evaluation (also known as “extended clock stopping”) because their data was not sufficiently mature when sent to the EMA. In 2023, the average duration of early MAA clock outages (198 days) was comparable to the average assessment duration (204 days). In 2022, the average clock outage was longer (205 days) than the assessment duration (196 days).
Officials at the EMA and the Medicines Agency are addressing these challenges with a series of comprehensive measures and a report with further recommendations for industry is being prepared.
