EMA to Improve Drug Approval Process

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The European Medicines Agency (EMA) announced on Oct. 2, 2024 that the agency is working with the European medicines regulatory network to improve the review and approval process for new medicines in the European Union. To improve efficiency, the agency plans to utilize the network’s resources, streamline drug review processes, and encourage applicants to provide more comprehensive submission applications. EMA hopes these efforts will accelerate the approval process.

The agency identified that the reliability of long-term planning for initial marketing authorization applications (MAAs) has been a recurring problem in need of improvement, which has led to slow approval times. According to EMA, only 35% of MAAs were submitted on time in 2023; only 30–40% of MMAs were submitted on time by the date on the letter of intent from 2018–2022. Requests for more time were made by 42% of applicants in 2023 because they did not have data mature enough at the expected time of submission. “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),” EMA stated in a press release (1). In September 2024, representatives from EMA, national competent authorities, and industry met at a workshop to discuss submission predictability. A report will be published with recommendations developed from the workshop.

Additional plans to improve sustainability of the EU regulatory network include the reinforcement of best practices for requests for clock-stop extensions, featuring a standard template for requests created by EMA’s Committee for Medicinal Products for Human Use (CHMP) and the Committee for Advanced Therapies (CAT). CHMP and CAT also began strictly applying provisions from the 2009 guideline on extensions in July 2024. “All requests for clock-stop extensions need to be well justified, and the CHMP and the CAT 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,” the agency stated in the press release.

EMA also revamped its two main assessment report templates in 2023. The agency is also planning the launch of a revamped “Overall Template” in January 2024. “With the new templates, there is a clearer differentiation between the evidence submitted by the applicant and EMA’s assessment. Information has been better structured, and duplication deleted,” the agency stated in the press release.

Other plans include the development of better guidance for assessors through report templates, guidance checklists, and training. EMA also piloted an automatic email notification to market authorization holders in 2023 that requests them to submit a list of planned line extensions and submission variations for the following six-month period. “This automatic request will be sent to each company contact point on 1 May and 1 November going forward. This will allow rapporteurs to have better visibility of the volume of post-approval work that they can expect in relation to a product,” EMA said in the release. The agency also plans to improve its dialogue with applicants in 2025.

Reference

1. EMA. Improving Efficiency of Approval Process for New Medicines in the EU. Press Release. Oct. 2, 2024.