Improving the efficiency of the approval process for new medicines within the European Medicines Agency (EMA) involves several strategies and ongoing reforms aimed at reducing the time to market while maintaining safety and efficacy standards.
On October 2, 2024, the European Medicines Agency (EMA) announced a series of measures towards efficient approval process for new medicines in European Union (EU). The main focus is to better utilize expert resources across the regulatory network, streamline assessment processes, and encourage applicants to submit more comprehensive and higher-quality application dossiers from the start.
Based on the historical data that highlighted significant issues with delayed submissions for Marketing Authorisation Applications (MAAs):
On-time Submissions: Only 35% of MAAs were submitted on time in 2023.
Historical Trends: Between 2018 and 2022, 30-40% of MAAs were submitted on time, indicating an ongoing problem with submission punctuality.
Requests for Clock-Stop Extensions: In 2023, 42% of applicants requested more time because their data were not mature enough at the expected submission time.
Additionally, the average duration of clock-stops in 2023 (198 days) was nearly as long as the average assessment time (204 days), and in 2022, the clock-stop period (205 days) even exceeded the assessment time (196 days).
In order to address the issue, a focus group was formed to analyze the historical data and monitor the MAA pipeline during the year 2023. And a multi-stakeholder workshop was held on September 25 to explore ways to improve submission predictability. Representatives from national competent authorities, the pharmaceutical industry, and the EMA reviewed several case studies to identify potential factors contributing to poor submission predictability.
On October 2, 2024, EMA made a press release on steps taken to improve the efficiency of the approval process for new drugs within the European Union. These efforts aim to accelerate the availability of safe and effective treatments by addressing several key challenges:
Better Resource Management: The EMA aims to optimize the use of expert resources across the regulatory network to streamline the drug evaluation process.
Timely Submissions: The agency seeks to improve the timeliness of Marketing Authorisation Applications (MAAs).
Quality of Submissions: The initiative encourages applicants to submit more comprehensive and mature dossiers at the initial submission to reduce clock-stop requests, which occur when incomplete data leads to delays during the review process.
Predictability and Communication: EMA plans to enhance pre-submission interactions and introduce automatic notifications to marketing authorization holders. This will improve the predictability of submissions and post-marketing activities, ultimately expediting the review and approval process.
These changes aim to minimize inefficiencies in the system, ensuring that important medicines can reach patients more quickly
Proposed Recommendations by the Focus Group
In addition to the measures to improve submission predictability and resource management, the EMA has several ongoing efforts to ensure the sustainability of the EU regulatory network:
Standardized Templates for Clock-Stop Requests: The EMA’s Committee for Medicinal Products for Human Use (CHMP) and the Committee for Advanced Therapies (CAT) have introduced a standardized template for clock-stop extension requests. This measure ensures more consistent and well-justified requests from applicants and limits delays caused by incomplete dossiers.
Stricter Enforcement of Guidelines: The CHMP and CAT are also strictly applying provisions from the 2009 guideline on clock-stop extensions, reducing the possibility of granting extensions for issues that should have been addressed during the initial submission.
Assessment Report Revisions: In 2023, the EMA revamped its two main assessment report templates to streamline and improve the evaluation process. These changes are aimed at enhancing transparency and consistency across the regulatory network.
Improved Communication Tools: The EMA plans to implement new communication tools in 2025 to facilitate better interaction between applicants and regulators during the pre-submission phase. This includes the use of automatic notifications to enhance the predictability and efficiency of the review process.
The implications of EMA’s measures towards improving the approval process are significant, as an efficient regulatory framework will foster innovation in the pharmaceutical industry, support public health needs, and maintain the EU's position as a leader in global drug regulation. The EMA’s ongoing efforts ensure the sustainability of the regulatory network, ultimately benefiting both patients and the broader healthcare system.
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