Periodic safety update reports
This page includes information on periodic safety update reports (PSURs), European Union (EU) reference dates for medicines and the frequency of submission of PSURs.
PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. Marketing authorisation holders (MAHs) must submit PSURs at defined time points following a medicine's authorisation. PSURs summarise data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorised uses and in unauthorised uses.
The Agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed. It can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.
Preparation of PSURs
The Agency has published an explanatory note to module VII of the guideline on good pharmacovigilance practices (GVP) providing additional clarification on the content of PSURs. All MAHs should consult the explanatory note when preparing PSURs. It addresses specific challenges in the EU single assessment procedure (PSUSA) for nationally authorised products, however, it highlights issues that may also apply to centrally authorised products. The explanatory note will form the basis of the upcoming revision of module VII of the GVP guideline and both documents should be read in conjunction.
EMA has also published a question-and-answer document for assessors in connection with the explanatory note to GVP module VII - see 'Assessment of PSURs' .
MAHs should also consult the following information when preparing the PSUR:
- Guideline on good pharmacovigilance practices: Module VII – PSUR
- Periodic safety update reports: questions and answers
Joint industry and national competent authority assessors' training
The European Medicines Agency organised a webinar on signals and close monitoring, safety specification, product information / reference safety information and the use of summary tabulations on 22 September 2017. These topics are described in the 'Explanatory note to good pharmacovigilance practice (GVP) Module VII' and in the 'Assessors' question-and-answer guidance on PSUR single assessment (PSUSA)'.
For more information, see PSUR roadmap: joint industry/assessor training
Submission of PSURs
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. MAHs should no longer submit PSURs to national competent authorities directly.
For more information on the changes to the submission of PSURs and how to use the PSUR repository, see:
Assessment of PSURs
Single assessments occur even though the active substances in question may be contained in medicines subject to different marketing authorisations and authorised in more than one Member State. This aims to harmonise and strengthen the safety and benefit-risk review of medicines across the European Economic Area.
The Agency sends the following documents to all MAHs whose medicines are part of a single PSUR assessment:
- preliminary single assessment report by the Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur;
- updated single assessment report by the PRAC rapporteur;
- PRAC recommendation;
- Committee for Medicinal Products for Human Use (CHMP) opinion (if applicable).
Single assessments of PSURs based on active substances and combinations of active substances for centrally authorised medicines began in July 2012. The Agency expanded this to active substances contained in centrally authorised medicines and in both centrally and nationally authorised medicines in April 2013.
The Agency also carries out the single assessment of active substances contained only in nationally authorised medicines. Information on how to submit these PSURs and to help marketing-authorisation holders prepare for single-assessment procedures (PSUSA) is available on Periodic safety update reports: questions and answers.
EMA has published an assessors' question-and-answer (Q&A) guidance document in connection with the explanatory note to GVP module VII:
List of EU reference dates and PSUR submission
The Agency maintains a list of EU reference dates (EURDs) and frequency of submission of PSURs for active substances contained in medicines in the EU:
The EURD list includes the active substances and combinations of active substances contained in medicines subject to different marketing authorisations and authorised in more than one Member State, together with:
- the corresponding EU reference dates;
- frequencies for submission of PSURs;
- related data lock points.
The EU reference date corresponds to the date of the first marketing authorisation of a medicine containing that active substance or that combination of active substances in the EU, or alternatively the earliest of the known dates of the marketing authorisations for a medicine containing that active substance or that combination of active substances.
The PSUR frequency and related data lock points for a given active substance or combination of active substances in the EURD came into effect on 1 April 2013. They overrule the submission schedule described in Article 107c (2) of Directive 2010/84/EU, and any conditions related to the frequency of submission of PSUR included in the marketing authorisation.
The EURD list aims to facilitate the harmonisation of data lock points and frequency of submission of PSURs for medicines containing the same active substances or combinations of active substances. This allows the single assessment of related PSURs to take place.
Amending the EURD list
MAHs and other stakeholders can request amendments to the EURD list for reasons of public health, to avoid a duplication of the assessment or to achieve international harmonisation. To request an amendment, stakeholders must complete the template below and send the request to email@example.com.
Any changes to the list, following a request for amendment, are approved or denied by the CHMP and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) following consultation with the PRAC.
List of European Union reference dates and frequency of submission of periodic safety update reports (XLS/1.5 MB) (updated)
First published: 01/10/2012
Last updated: 27/11/2018
EMA/630645/2012 Rev. 75 corr. 1
Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports (PDF/155.77 KB)
First published: 01/10/2012
Last updated: 22/10/2018
EMA/606369/2012 Rev. 16