Improving efficiency of approval process for new medicines in the EU
Measures to optimise use of the EU's expert resources for faster assessments
News
EMA and the European medicines regulatory network are working to further improve efficiency in the assessment 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 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.
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.
Other ongoing measures that aim to ensure the sustainability of the EU regulatory network are:
- Reinforcing best practices for requests for clock-stop extensions: In April 2024, EMA’s human medicines committee (CHMP) and the Committee for Advanced Therapies (CAT), introduced a standard template for the request of clock-stop extensions. In addition, from July 2024, both committees have started to apply the provisions of the 2009 guideline more strictly. 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.
- Streamlined templates: In 2023, EMA revamped its two main assessment report templates: the ‘Day 80 non-clinical assessment report’ and the ‘Day 80 clinical assessment report’ Assessment templates and guidance. Work is ongoing on the quality assessment report as well as a dedicated ‘Day 80 clinical assessment report’ for biosimilars. In addition, the launch of a revamped ‘Overview template’, which evolves from Day 80 of the procedure until the final European Public Assessment Report (EPAR), is planned for January 2025. 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.
- Better guidance for assessors: A number of initiatives are ongoing, looking to provide better guidance to assessors in the national competent authorities, whether through the assessment report templates, guidance and/or checklists and training, with the overall aim of building efficiency and consistency in the assessment process.
- Better predictability of post-marketing activities: In May 2023, EMA piloted an automatic email notification to all marketing authorisation holders, requesting them to submit a list of their planned line extension and major variation submissions 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.
- Closer dialogue with applicants: In 2025, EMA plans to launch a project dedicated to improving pre-submission interactions with applicants. A joint project with NCAs and industry associations will aim to find practical solutions to address the increasing number of dossiers submitted with premature data and to improve submission predictability through closer communication between the applicant, EMA and rapporteur teams well in advance of the planned MAA submission date.