EU aims to make medicines review more efficient

The European Medicines Agency (EMA) and the European medicines regulatory network plan to improve the efficiency of how new medicines are assessed and approved.

A new initiative aims to better manage the use of the network’s expert resources, streamline assessment processes, and encourage better and more comprehensive application dossiers from applicants at the time of initial submission.

The overall objective of the initiative is to accelerate the availability of safe and effective treatments for patients, the EMA said in a statement.

One of the areas identified for 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, absorbing precious assessment resources and slowing down medicine approval times.

A recent report published by EMA found that, 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.

The report also found that 42% of companies seeking marketing authorisation 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.

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).

The EMA and the Heads of Medicines Agencies (HMA) held a workshop with stakeholders in late September to discuss measures that would improve the process.