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