Periodic safety update reports (PSURs)
This page includes information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list.
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.
Article 35 of the Commission Implementing Regulation describes the structure of PSURs. Module VII of the Guidelines on Good Pharmacovigilance Practices (GVP) provides guidance on the preparation, submission and assessment of PSURs.
The Agency has also published an explanatory note to GVP module VII, which all MAHs should consult when preparing PSURs. It addresses specific challenges in the EU single assessment procedure for nationally authorised products, but the issues may also apply to centrally authorised products.
For more information on GVP modules, see Good pharmacovigilance practices.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure.
For more information on how to use the PSUR repository, see:
Further information on the PSUR repository, guidance on how to register and multimedia tutorials for MAHs on how to submit a PSUR in the correctly-structured electronic formats can be found on EMA's eSubmission website.
The list does not include substances assessed at national level, although their PSURs must nonetheless be submitted via the PSUR repository. For these active substances, the frequency of submission is established at national level. For more information, see:
- frequency of PSUR submission;
- data lock point;
- submission date;
- requirements for the submission of PSURs for generic, well-established use, homeopathic and traditional herbal products.
The EURD list is a legally binding document and MAHs are legally responsible for complying with its requirements. The list overrules the 'standard' PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.
EMA updates the EURD list every month, following adoption by the Committee for Medicinal Products for Human Use (CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), after consultation with the Pharmacovigilance Risk Assessment Committee (PRAC).
Any amendment to the EURD list becomes effective six months after its publication.
For more information on the EURD list and answers to frequently-asked-questions, see the following document:
- extract of the relevant active substances/combinations from the Article 57 database for which the addition/amendment is requested.
Before submitting a request, EMA encourages stakeholders to carefully consult the introductory cover note. There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time.
PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure.
EMA carries out PSUSA procedures to assess PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorisations and are authorised in different EU Member States. This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area.
For more information, see the questions-and-answers below and Periodic safety update report single assessments.