EMA’s strategy for speeding up drug approvals in the EU
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the pandemic, Ben Hargreaves finds the agency aiming to streamline processes and improve collaboration with applicants.
The European Medicines Agency (EMA) has experienced a turbulent few years. Brexit left the agency reeling, as it was forced to move from its base in London and reduce its services whilst navigating the move to Amsterdam. By 2019, the agency had begun operating from its new home, only for the arrival of COVID-19 to disrupt activity once again. The demands of the pandemic period meant carrying out standard activities whilst also expediting the review of potential treatments and vaccines against the virus, which led to the reduction or suspension of certain tasks.
Emerging from the other side of this period has left the agency reflecting on its processes. In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage the use of the network’s resources, streamline assessment processes, and encourage better and more comprehensive application dossiers from applicants at the time of initial submission.
The importance of efficiency
The efficiency of the approval process for new medicines in the EU is vital. From a patient perspective, the longer it takes for a treatment to be approved, the longer they must wait to receive the drug. In a number of conditions, this can have a dramatic impact, whether on their quality of life or the likelihood of staying alive.
From a business perspective, the time taken for a drug to hit the market can dramatically impact revenue and the treatment’s ability to compete. With the average R&D cost for drug development being $2.3 billion, the urgency to turn this cash burn into cash generation is crucial for many businesses. In addition, a responsive and efficient approval process fosters an environment that encourages research and development within the EU.
According to the EMA, “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.”
In line with this observation, the agency held a multi-stakeholder workshop to discuss submission predictability, which resulted in a report that outlined some of the reasons and solutions for delayed MAAs.
Understanding the problem
To outline the issues the agency is facing, it provided three statistics that set out the challenges it aims to tackle:
- In 2023, the percentage of MAAs submitted on time 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)
During the multi-stakeholder meeting, the agency stated that striving for 100% success in achieving predictable submission dates is not possible. This is due to myriad factors that can complicate and change submission dates for innovative medicines. The list of factors provided by the agency is 11 potential issues long and includes: uncertainty of clinical trial outcomes; patient recruitment duration; last minute regulator requests; and lack of knowledge of European regulatory framework, among other potential challenges.
However, a reduction in delays is still a vital aim for the agency. The greater the number of delays in the application process, the fewer drug approvals secured each year, at least according to research conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The industry body identified the “speed of the regulatory process” as one potential root cause of delays and drug unavailability.
In full year 2023 figures, the EMA recommended 77 medicines for marketing authorisation. This represented a 13% drop on the previous year and the third consecutive where approval numbers had fallen from a high of 97 in 2020.
Closer dialogue
The conclusion of the agency’s review sees the EMA plan to tackle delays in medicine approval by enhancing both submission predictability and regulatory preparedness. A key component involves intensifying pre-submission interactions to assess each application’s readiness. Through these interactions, the EMA aims to identify challenges early, such as requests for accelerated assessments or novel clinical methodologies, which may require additional resources.
To improve submission timing, the Letter of Intent (LoI) will be revised with a detailed annex that clarifies the data requirements and emphasises that resources are allocated based on the applicant's planned submission date. Rapporteurs—responsible for evaluating applications—will be appointed three months before submission rather than the current six, making adjustments if other measures do not prove sufficient.
Efforts to streamline communication with applicants include automated reminders for post-authorisation plans, additional training on the implications of submission timing, and stress on the importance of rapid responses to the EMA's requests.
The EMA will monitor the impact of these measures, aiming for refined submission predictability by tracking and addressing any recurring issues. If these adjustments are successful, the EMA plans to extend systematic monitoring into 2025 to maintain improvements.
