An EPAR, or European Public Assessment Report, is a document published by the European Medicines Agency (EMA) that explains how a medicine was scientifically evaluated and why it was approved or rejected for use in the European Union. One is published for every human or veterinary medicine that goes through the EU’s centralized authorization process. Think of it as a detailed public record of the evidence behind a drug’s approval, available for anyone to read.
What an EPAR Contains
Each EPAR includes several components: an overview of the medicine, its official product information, the full scientific assessment report, and a risk management plan. The scientific assessment reflects the conclusions of the EMA committee responsible for evaluating the application. It covers what the medicine is used for, how it works, what clinical studies were conducted, what benefits were demonstrated, and what risks were identified during review.
The full technical report is written for healthcare professionals and regulators, so it can be dense. To make the information accessible, each EPAR also includes a plain-language summary written for the general public. This summary covers the purpose of the report, what the medicine treats, the studies that were done, specific risks, and the reasoning behind the approval decision. One useful detail that sets this summary apart from the leaflet inside a medicine’s packaging: the EPAR summary often includes numerical information about how likely the medicine is to benefit you, something patient leaflets typically leave out.
Which Medicines Get an EPAR
Not every medicine sold in the EU has an EPAR. The report is only produced for medicines evaluated through the EMA’s centralized authorization procedure, which grants a single marketing approval valid across all EU member states. This centralized route is mandatory for certain categories:
- New treatments for specific diseases: HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune disorders, and viral diseases
- Biotechnology-derived medicines: products made through processes like genetic engineering
- Advanced therapies: gene therapies, cell therapies, and tissue-engineered medicines
- Orphan medicines: treatments for rare diseases
Companies can also voluntarily use the centralized procedure for other medicines, particularly if they contain a new active substance or represent a significant therapeutic innovation. However, most generic medicines and over-the-counter products are authorized at the national level by individual EU countries and do not receive an EPAR. Many older medicines also lack one because they were approved before the EMA existed.
When EPARs Are Published
An EPAR is published approximately two weeks after the European Commission issues its formal decision on a medicine. This applies whether the medicine was approved or refused. If a medicine is refused authorization, the EPAR still gets published, explaining the scientific reasons behind the rejection.
How EPARs Are Updated Over Time
An EPAR is not a static document. After a medicine reaches the market, the EMA continues to monitor its safety. When new safety studies are completed, the results are reviewed by the agency’s safety committee. If that review leads to changes in how the medicine should be used, such as new warnings, revised dosing guidance, or restrictions, the product information tied to the EPAR is updated through a formal regulatory decision. The outcomes of required post-approval safety studies are published as part of the medicine’s EPAR, so the report grows over time to reflect what has been learned since the original approval.
What Information Is Withheld
EPARs are designed to be transparent, but some information is redacted before publication. The exceptions are narrow: details about how a medicine is manufactured, information about production facilities and equipment, and certain contractual arrangements between companies. Clinical data and the scientific reasoning behind approval decisions are not withheld.
How to Find an EPAR
The EMA hosts a searchable medicine database on its website (ema.europa.eu/en/medicines) where you can look up any centrally authorized medicine by name or active ingredient. Each medicine’s page links to its full EPAR, including the public summary, product information, and scientific assessment. An advanced search option lets you filter by medicine type, authorization status, or therapeutic area, and you can also find reports for medicines that were refused or withdrawn from the market.
For anyone researching a specific medication approved in Europe, whether you’re a patient, a healthcare professional, or simply curious, the EPAR is the most comprehensive publicly available source of information on why that medicine was deemed safe and effective enough to approve.