The European Medicines Agency is looking to speed up its drug review timelines, following a recent report showing how applications can see long delays.
Beginning in 2023, the EMA began monitoring every new marketing application to get a better understanding of delays. It found that only 35% of applications were submitted on the agreed-to time by the sponsor, and 21% were submitted with a delay.
“This is in line with 2018-2022 data, which indicates that each year only 30-40% of expected [marketing authorization applications] are submitted on the date indicated in the letter of intent,” which is the final document required before a submission, EMA said in a statement on Tuesday.
Next year, the agency says it plans to launch a project to improve pre-submission with applicants. The goal is to address the increasing number of applications submitted with premature data and to improve submission predictability through closer communication in advance of the planned submission date.
Even after an application is submitted, the 2023 review found 42% of companies seeking marketing authorization requested more time to respond to questions from EMA’s scientific committees “because their data was not mature enough when it was submitted,” the agency said.
Unlike in the US, drugmakers in the EU can stop the clock on their assessments as they prepare additional responses for the regulator.
Those delays, however, can add up. According to the agency, in 2023 the average total of those delays was 198 days — almost as long as the 204 days that the average assessment took.
“These challenges are being addressed by EMA and the Heads of Medicines Agencies (HMA) through a series of comprehensive measures,” the agency said in its statement.
Moving forward, the EMA says all requests for clock-stop extensions “need to be well justified and the [Committee for Human Medicine Products] and the [Committee for Advanced Therapies] will no longer grant extended clock-stops to solve problems caused by immature application dossiers or issues that were foreseeable prior to the submission of the application.”
In 2023, EMA revamped its two main assessment report templates, and the launch of a revamped “overview template” — which EMA says “evolves from Day 80 of the procedure until the final European Public Assessment Report” — is planned for January 2025.