What are the EMA’s timelines for the standard and accelerated procedures?
The European Medicines Agency (EMA) plays a central role in the scientific evaluation, supervision, and monitoring of the safety of medicines within the European Union (EU).
The EMA offers two types of procedures for evaluating MA applications: the standard procedure and the accelerated procedure, each following a clearly defined timeline.
The EMA’s role in drug regulation
Created in 1995, the EMA coordinates the scientific evaluation of medicines in the European Union. It centralizes marketing authorization applications to enable pharmaceutical companies to obtain a single authorization valid in all EU Member States, Iceland, Liechtenstein, and Norway.
Depending on the urgency of the medical need or the innovative nature of the medicine, companies can opt for a standard procedure or, if they meet certain criteria, request an accelerated procedure.
For further reading: How to obtain a marketing authorization (MA) for a new medicine?
Standard procedure timeframes
The EMA’s standard procedure follows a fixed 210-day timeline, to which may be added clock stops during which the applicant responds to questions posed by the Committee for Medicinal Products for Human Use (CHMP).
Details of the standard timeline:
- Day 1: The assessment officially begins.
- Day 70: The rapporteur and co-rapporteur submit their preliminary assessment report.
- Day 100: End of the CHMP member comment period.
- Days 115-120: The CHMP discusses and adopts the list of questions to be addressed to the company.
- Day 120: Start of the clock-stop period, during which the company prepares its responses.
- Day 121 (resumption): Responses are received and the assessment restarts.
- Day 150: Final assessment report (joint assessment) is submitted to the CHMP.
- Day 170: End of comments on this report.
- Day 180: Final discussion by the CHMP and preparation of the opinion.
- Day 210: Adoption of the CHMP opinion and transmission to the European Commission.
Why can the time between submission of a dossier and EMA approval exceed 300 days?
The marketing authorization process at the European level is strictly regulated, but several steps can extend the time beyond 300 days:
- Duration of the standard evaluation procedure: The evaluation of a drug by the EMA theoretically lasts 210 days. However, this period can be interrupted several times to allow the applicant to respond to questions from the Committee for Medicinal Products for Human Use (CHMP). These interruptions are called “clock stops.”
- Impact of clock stops: Each clock stop temporarily suspends the countdown. Its duration depends on the time it takes the company to submit its responses to the EMA’s requests. These interruptions can add several weeks or even months to the overall process. The countdown then resumes where it left off (clock restart).
- European Commission decision time: Once the CHMP issues a positive (or negative) opinion, the European Commission has an average of 67 days to issue its final decision.
In the event of a positive opinion, the European Commission publishes the marketing authorization, which is valid throughout the EU.
Accelerated assessment timeframes
Marketing authorization under the accelerated assessment procedure is a European Union mechanism designed to enable faster access to innovative treatments of major public health interest. This implies that the authorization decision has been taken following an accelerated scientific evaluation procedure by the EMA.
Under the centralized assessment procedure, the standard timeframe for assessing a marketing authorization application is 210 days (excluding clock stops).
However, when the CHMP accepts an application for accelerated assessment for a medicinal product of major public health interest or a therapeutic innovation, the processing time is reduced to 150 days (excluding clock stops).
For this type of medicinal product, this 150-day period is divided into two phases: 120 days for the first phase, followed by 30 days for the final phase, with a clock stop allowed up to 3 months after the 120th day to allow the company to submit written responses.
Eligibility criteria for the accelerated assessment procedure:
- Marketing Authorization (MA) application
The general steps of this procedure are detailed on the European Medicines Agency’s website. - Major public health interest (Article 14(9) of Regulation (EC) No. 726/2004)
The medicinal product must be of major public health interest, particularly from the perspective of therapeutic innovation. - Meeting patient expectations and scientific developments
The medicine must meet patients’ legitimate expectations. It must also adapt to the constant evolution of scientific knowledge and available therapies, as emphasized in several of the European regulations’ recitals.
Furthermore, it should be noted that although the timeline is compressed, it may also include clock stops. Furthermore, in the event of technical difficulties or the need for major additional data, the EMA may decide to revert to the standard procedure. Finally, as with the traditional procedure, the opinion is forwarded to the European Commission for a final decision.
Also read: Focus on early access and compassionate use programs
Comparison of the two procedures: standard vs. accelerated
The EMA’s classic procedure provides for an assessment period of 210 days, excluding time limits during which the company responds to questions from the Committee for Medicinal Products for Human Use (CHMP). It applies to the majority of MA applications and does not require any specific justification.
On the other hand, the accelerated procedure is reserved for medicines considered a public health priority, particularly when they address diseases for which there are unmet medical needs. It allows for a reduction in the evaluation period to 150 days. This reduction is not automatic: the laboratory must submit a reasoned request to the EMA, which assesses the eligibility of the application before acceptance.
In both cases, the procedure may be temporarily suspended if the CHMP requests additional information. Once the CHMP’s opinion is issued (on day 210 for the standard procedure, or on day 150 for the accelerated procedure), the European Commission makes the final authorization decision, generally within approximately 67 days.
Conclusion
For pharmaceutical companies, mastering the EMA’s evaluation periods is essential for effectively planning the marketing of new medicines.
The classic procedure, with its 210-day evaluation period, remains the standard for most drugs. However, for treatments with high therapeutic potential, the accelerated procedure offers a faster regulatory pathway, provided they meet strict criteria.
In both cases, rigorous preparation of the application and anticipation of time-sensitive deadlines are essential to meet deadlines and maximize the chances of obtaining marketing authorization.
