Wondering how a new medicine reaches shelves across Europe? The EMA drug approval process runs through scientific committees: up to 210 active days of evaluation, then a European Commission decision.
| Item | Value |
|---|---|
| CHMP evaluation of a centralised application | Up to 210 active days |
| European Commission decision after the CHMP opinion | Within 67 days |
| Median submission-to-approval, EMA, cancer new drug applications | 424 days |
| Median submission-to-approval, FDA, same study | 216 days |
| EMA and FDA agreement on final decision, cancer new drug applications | 94% |
Figures come from the EMA step-by-step guide and a peer-reviewed comparison of cancer drug applications. Procedures and timings can change, so check the sources before you rely on them.
What the EMA does, and what it does not do
The European Medicines Agency (EMA) is the body that scientifically evaluates many medicines for the European Union. It does not, by itself, grant the legal permission to sell a product. That final step belongs to the European Commission.
The centralised procedure lets a company file one application with the agency. According to the EMA, this allows a company to “submit a single marketing authorisation application to EMA” and to market the medicine across the European Economic Area on the basis of a single authorisation.
This page is general education about regulation. It is not medical advice and says nothing about whether any particular medicine works. Questions about your own treatment belong with a physician or pharmacist.
Regulation sits at the far end of a long pipeline. A candidate usually spends years in laboratory work and testing before anyone prepares a file for a regulator, and many candidates stop along the way. Understanding where the EMA sits in that chain helps explain why approval statistics describe only a small, filtered group of products. If you want the wider context of how candidate molecules are found in the first place, start with what is drug discovery.
Steps before an application is submitted
Regulatory work starts well before the formal filing. The EMA describes a series of preparatory steps that an applicant is expected to take.
- Appointment of rapporteurs, the committee members who lead the assessment.
For advanced therapy medicines, the EMA states that “(co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment.” This reflects how specialised some products are.
Preparatory work should be distinguished from earlier research, including laboratory work such as high throughput screening. Such research may help identify candidates for further study, but an early laboratory result alone does not establish suitability for use as a medicine.
How the EMA drug approval process assesses an application
Once an application is submitted, the agency’s scientific committees assess it. The main one is the Committee for Medicinal Products for Human Use (CHMP). The EMA says these committees are “composed of members from each of the EU Member States and from Iceland and Norway, plus co-opted members who provide additional expertise in particular scientific areas.”
The evaluation “takes up to 210 active days,” in the EMA’s wording. Because the count is in active days, the calendar time from submission to opinion may differ from the headline figure.
In general discussions of medicines, these terms describe different aspects of the evidence:
- Quality: how the substance and finished product are made and controlled.
- Safety: what the data show about adverse effects and how risks would be managed.
- Efficacy: whether the submitted evidence supports the claimed benefit for the stated use.
The comparative research cited below illustrates the importance of interpreting evidence. It attributes differences between agency decisions mainly to differing conclusions about efficacy, based on the same data or different clinical data submitted.
These definitions help readers distinguish questions about a medicine; they do not, by themselves, explain how a particular application will be decided. The evidence quoted here describes the CHMP evaluation and the scientific opinion that follows it. It also describes differences between agency conclusions about efficacy. Those findings do not provide a formula for predicting an opinion from an individual research result, or for deciding how any particular uncertainty will affect the outcome.
When reading the comparisons below, separate the evidence submitted from the conclusions drawn from it. The cited analysis allows for both differences in interpretation of the same data and differences in the clinical data submitted. Agreement on an approval decision therefore should not be taken to mean that every scientific conclusion was identical. Likewise, a difference in decisions does not by itself tell a reader which evidence caused it. Understanding a particular application would require looking at that application and the reasoning behind its assessment, rather than treating these general definitions or the reported agreement figures as a substitute.
The opinion and the Commission decision
At the end of the evaluation, the EMA says that “the CHMP issues a scientific opinion on whether the medicine may be authorised or not.” The agency then sends that opinion to the European Commission.
The Commission issues the legal decision. The EMA lists the timing as “within 67 days of receipt of CHMP opinion.”
Once granted, the EMA notes that the centralised authorisation “is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.”
How EMA timelines compare with the FDA
Readers often ask how this differs from the fda drug approval process. The two agencies run different procedures, so direct comparisons need care.
One study of cancer drug applications reported that for new drug applications, “the time from submission to approval in the EMA and the FDA were median (interquartile range, IQR) 424 (394-481) days and 216 (169-243) days, respectively.” The same study found “agreement in the final decision between the EMA and the FDA” in 94% of new drug applications, as set out on the published paper.
A separate analysis of applications reviewed by both agencies found that decisions on first submission were concordant for 92% (98/107) of the applications. After resubmission or reexamination, the paper reports that concordance rose to 98% (105/107). The authors, writing in a journal article, attribute divergence mainly to differences in conclusions about efficacy “based on review of the same data or differing clinical data submitted.”
These results cover specific product groups and periods, so they should not be read as a statement about every medicine or every year.
Limits and uncertainty
An authorisation is a judgement made on the evidence available at one point in time. It says nothing certain about how any individual will respond, and it does not remove uncertainty about long-term effects.
Several limits are worth keeping in mind:
- Active-day counts may not match the real elapsed time.
- Comparisons between agencies depend on the sample, the years and the way “approval” is defined.
- Agreement between regulators does not show that either decision is correct.
- Many candidate medicines never reach a regulatory submission, so the approved set is a small, filtered view of development.
Frequently asked questions
Does the EMA itself authorise medicines?
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No. The EMA’s CHMP issues a scientific opinion, and the European Commission issues the marketing authorisation, according to the EMA’s step-by-step guide.
What does “210 active days” mean?
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It is the EMA’s cap on the CHMP evaluation of an application. Because it counts active days, calendar time may differ.
Where is a centralised authorisation valid?
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In all EU Member States and in the EEA countries Iceland, Liechtenstein and Norway, per the EMA.
Is the EMA slower than the FDA?
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In one study of cancer drug applications, the median time from submission to approval was longer at the EMA (424 days) than at the FDA (216 days). That finding applies to that study sample only.
This article is for information only. It is general education about science and the drug industry, and it is not medical, treatment or investment advice.
