European public assessment reports: background and context
The European Medicines Agency (EMA) publishes detailed information on the medicines assessed by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP). The main vehicle for this information is known as a European public assessment report.
A European public assessment report (EPAR) is published for every human or veterinary medicine application that has been granted or refused a marketing authorisation. This follows an assessment by EMA of an application submitted by a pharmaceutical company in the framework of the Central authorisation of medicines.
An EPAR provides public information on a medicine, including how it was assessed by EMA. The EPAR is referred to in Article 13(3) of Regulation (EC) No 726/2004, which requires EMA to publish a public assessment report for each centrally authorised medicine together with a public-friendly overview.
EMA has developed the EPAR concept over time to ensure that it delivers a usable, transparent and appropriately detailed body of information. The EPAR content and structure have therefore evolved over time and may be further developed in future.
An important role of the EPAR is to reflect the scientific conclusions of the relevant EMA committee at the end of the assessment process, providing the grounds for the committee opinion on whether or not to approve an application.
All EPARs are published on the EMA website and can be viewed under human medicines and veterinary medicines.
Content and format
An EPAR is not a single document but an information resource containing several components, including a core set of regulatory documents. EPARs are displayed on the EMA website and the individual components can be viewed online, downloaded and/or printed out.
Information handled during the scientific assessment which is considered confidential is removed before an EPAR is published.
EPARs are updated periodically to reflect the latest regulatory information on medicines. If the original terms and conditions of a marketing authorisation are varied, the EPAR is updated to reflect such changes with an appropriate level of detail.
EPARs are displayed on the EMA website using four different sections containing different components of the EPAR. The below table provides an overview:
|Section||Type of information|
|Overview||Public-friendly overview in question-and-answer format.|
|Authorisation details||Key details about the product and the marketing authorisation holder.|
|Product information||Package leaflet and summary of product characteristics; labelling; list of all authorised presentations; pharmacotherapeutic group; therapeutic indications.|
|Assessment history||Public assessment report for the initial authorisation; public assessment report(s) for any variation concerning major changes to the marketing authorisation; orphan maintenance assessment report or withdrawal assessment report (as of 17 January 2018); tabulated overview of procedural steps taken before and after authorisation.|
The detailed format and content of the public-friendly overview have been adapted and enhanced over time, but the main principles are set out in a reflection paper:
Timing of publication
The EPAR for each medicine is published or updated after the European Commission has issued a decision regarding the application. In addition, whenever the product information is updated, the medicine's EPAR is updated accordingly to reflect the latest version.
For a new marketing authorisation or a major change to the authorisation terms, this process takes around two months following the adoption of an EMA scientific opinion, so there is a delay between adoption of opinion and publication or updating of the EPAR. Pending the European Commission decision, the EMA publishes a 'summary of opinion' immediately after the scientific opinion is adopted. Summaries of opinion can be found under Pending EC decisions (human) and Pending EC decision (veterinary).
Some components of the EPAR are always published in all official EU languages:
- Public-friendly overview;
- Package leaflet and summary of product characteristics;
- List of all authorised presentations.
The other elements of the EPAR are published in English only:
- Public assessment report(s);
- Tabulated overview of procedural steps taken before and after authorisation;
- Other content available only as a web page (e.g. information under the 'Authorisation details' tab).
Negative opinions and withdrawn applications
The EMA has established procedures for publishing information following the refusal of a new marketing authorisation application or an application to vary an existing authorisation, and following the withdrawal of an application by the applicant. The procedures cover the publication of public assessment reports and additional information to ensure transparency.
For more information, see:
- Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products
- Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products
Although the Agency makes its best efforts to provide accurate information, please note that for documents published before 1 July 2010, the date that of first publication displayed on the web page shall be deemed as indicative and estimated only. As a tool for managing web content, the date 'first published' and the date 'last updated' has been introduced only as of 1 July 2010.
The Agency publishes the Norwegian and Icelandic versions of product information for ease of reference only. The Agency is not responsible for their accuracy or completeness. Publication by the Agency does not mean that a national decision on the marketing authorisation has been taken by the Norwegian or Icelandic competent authorities. In case of further questions regarding decision-making in these countries, please contact the Norwegian or Icelandic national competent authority directly.
To enable browsing by therapeutic area for human medicines, the EMA website uses the Medical Subject Headings (MeSH) controlled vocabulary developed by the United States National Library of Medicine. The MeSH terms are allocated by EMA in order to improve the usability of the EMA website; they do not constitute official information on the medicine. The 2010 version of MeSH is currently being used. The Agency is using branches C, E, F, G and N of the MeSH taxonomy tree. To facilitate easier searching for the non-specialist, some of the terms on the first and second levels have been modified. To enable browsing by species for veterinary medicines, a list of species has been developed by the Agency that only includes target species for medicines for which the EMA has published an EPAR. It is not an exhaustive list of all animal species.