What is European Public Assessment Report (EPARs) and Periodic safety update reports (PSURs)?

What is European Public Assessment Report (EPARs) and Periodic safety update reports (PSURs)?

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. Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits EMA and national competent authorities assess information in PSURs to determine if there are new risks identified for a medicine and/or if its risk-benefit balance has changed. A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health (e.g. an update of the information provided to healthcare professionals and patients). Marketing authorisation holders (MAHs) are legally required to submit PSURs, in line with Regulation (EU) No 1235/2010, Directive 2010/84/EU and Commission Implementing Regulation (EU) No 520/2012.