EMA concerned about MAA delays, working on solutions
The European Medicines Agency (EMA) and the European Medicines Regulatory Network are concerned that marketing authorization applications (MAA) are not being handled efficiently, leading to significant delays in reviewing and ultimately bringing products to market. The agency recently held a stakeholder meeting on the topic and is engaged in several initiatives to find potential solutions.On 2 October, EMA issued a statement that it is concerned that the current assessment and approval process used to get drugs on the European market is not efficient enough and is working on ways to improve the current regulatory process.
“One of the areas identified as needing improvement is the reliability of long-term planning for initial marketing authorization applications (MAAs),” said the agency. “This has been a recurrent problem for the network for many years, binding precious assessment resources and slowing down medicine approval times.”
EMA noted that data from a focus group report earlier this year found that only 35% of MAAs were submitted on time, almost identical to the percentage of applications in the previous four years. The report also found that 42% of applicants in 2023 asked for additional time by requesting an extended stop-clock to respond to EMA scientific committee questions because their data was insufficient.
Stakeholders met during a workshop on 25 September to discuss how MAAs can be improved and more predictable. EMA said it will take what it learned from the meeting and publish a report to help stakeholders better understand the challenges and potential solutions.
In the meantime, EMA and the EU regulatory network are taking several steps to improve the regulatory process, including reinforcing clock-stop extension best practices by launching a standard clock-stop extension template in April. EMA’s human medicines committee (CHMP) and the Committee for Advanced Therapies (CAT) are also stricter about implementing a 2009 clock-stop extension guideline.
“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,” said EMA.
EMA said it is working to develop better guidance for assessors in the national competent authorities (NCA) through potential new assessment report templates, guidance and/or checklists, and training. Furthermore, next year it plans to launch a project to improve pre-submission interactions with applicants in a joint project with NCAs.
“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,” said EMA.
EMA statement
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