EPAR: European public assessment report

Article 13(3) of Regulation (EC) No 726/2004 requires EMA to publish the assessment report of the Committee for Medicinal Products for Human Use, with the reasons for its opinion, after deleting any information of a commercially confidential nature. The published set of documents is the EPAR. Under Article 11 and Article 13 EMA also publishes assessment reports where an application is refused or withdrawn after the committee has started its assessment, so the public record covers failures as well as approvals.

An EPAR contains several documents. The public assessment report, called the scientific discussion for older products, sets out the quality, non-clinical and clinical evidence, the committee's questions and the applicant's answers, the benefit-risk conclusion and any conditions. It is accompanied by the product information in all official languages, a plain-language summary for the public, the procedural steps taken before and after authorisation, and the list of all variations assessed since approval, with assessment reports for major changes such as new indications. For products authorised under conditional authorisation or in exceptional circumstances it records the specific obligations and their deadlines.

The EPAR is published after the Commission decision and is updated throughout the product's life, so it is the first place a competitor looks to understand how a product was developed and assessed. Generic and biosimilar developers read the clinical sections to see which comparators and endpoints the committee accepted, which studies failed and why, and what questions were raised about the manufacturing process. Originators read competitors' EPARs for the same reasons. National authorities publish public assessment reports for mutual recognition and decentralised procedures, in a shorter format, on the Heads of Medicines Agencies website.

What goes wrong: a team quotes a figure from an EPAR without checking whether a later variation changed it; commercially confidential information is requested to be redacted too broadly and the committee refuses, leaving process details public that the company expected to protect; the withdrawal assessment report for a failed application is treated as unpublished when it is on the website; and the summary of product characteristics in the EPAR is relied on when the nationally implemented translation, not the EPAR, is the legally binding text in a given country.