European public assessment report

from Wikipedia, the free encyclopedia

The European Public Assessment Report (EPAR;. English for European public assessment report ) is a document of the European Medicines Agency EMA , where the Committee for Human Medicinal Products (CHMP) and the Committee for Veterinary Medicinal Products (CVMP) the public in detail about the official assessment of a new drug or veterinary medicinal product .

concept

The European Public Assessment Report is compiled and published by the European Medicines Agency (EMA) for every medicinal product for human or veterinary medicine submitted for a central authorization procedure . The core element is the scientific discussion in which the risk-benefit ratio is carefully weighed up. It concludes with a positive or negative recommendation ( positive / negative opinion ) from the committee, on which the granting or rejection of drug approval by the European Commission is based.

The report is published on the basis of Article 13 (3) of Regulation (EC) No. 726/2004 .

Content and format

The European Public Assessment Report consists of several parts. Regulatory documents are included. Confidential information (such as information about the manufacture of the product) that is made available by the pharmaceutical company during the evaluation of the authority is not listed in the report. The report is continuously updated to make significant changes to the drug currently available to the public.

The report consists of the following parts:

  • Summary of the EPAR for the public
  • Details about drug approval : area of ​​application in therapy , international non- proprietary name, time of approval, holder of approval
  • Product information: Summary of the product characteristics , package insert and a list of all forms of presentation ( dosage forms , strengths, pack sizes)
  • Evaluation history with a detailed scientific discussion. In addition to the initial scientific assessment, all subsequent assessments of the medicinal product, for example resulting from changes to the medicinal product introduced by the applicant or from new findings on the benefit-risk ratio, are published.

publication

Parts of the EPAR such as the summary for the public, product information, package insert and a list of all forms of presentation are published in all official languages ​​of the European Union . The public evaluation report is only published in English.

Web links

Individual evidence

  1. ↑ a b c d e f European Public Assessment Report background and context. EMA, accessed March 27, 2019 .
  2. ↑ Regulation (EC) No. 726/2004