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Regulatory information - European Medicines Agency s guidance on European Union periodic-safety--report single assessment for nationally authorised medicines


Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines

The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the submission of periodic safety update reports (PSURs) for nationally authorised medicines subject to European Union (EU) single assessment.

The single assessment of nationally authorised medicines is a deliverable of the 2010 pharmacovigilance legislation. It aims to harmonise and strengthen the review of the benefits and risks of all medicines across the EU. PSUR single-assessment procedures involving a combination of centrally authorised medicines and nationally authorised medicines have been in place since April 2013.

All EU PSUR single assessments result in a recommendation from the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).

Marketing-authorisation holders with medicines subject to a PSUR single assessment involving nationally authorised medicines only, for which the frequency and dates of submission of the PSUR have been established in the list of EU reference dates (EURDs), have to submit their PSURs to all Member States where their medicine is authorised, and to the EMA. This applies to medicines with data lock points falling on or after 1 September 2014.

These PSURs will be assessed by either a PRAC member for single-assessment procedures involving a combination of centrally authorised medicines and medicines authorised through mutual-recognition, decentralised or purely national procedures, or a Member State appointed by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), for PSUR single-assessment procedures involving nationally authorised medicines only. This will result in one single assessment report which will be shared among the marketing-authorisation holders whose medicinal products are part of the PSUR single-assessment procedure. Marketing-authorisation holders have the possibility to comment on the assessment report, following which the PRAC will adopt its recommendation.

For all EU PSUR single-assessment procedures starting from October 2014, the procedure number will be published in advance in the EURD list. Marketing-authorisation holders should therefore include their procedure number when preparing their submission. Marketing-authorisation holders of nationally authorised products should also complete Annex I of the formatted table template of the cover letter.

The PSUR timetable has also been adapted to integrate the PSUR single-assessment procedures containing nationally authorised medicinal products. This timetable was published in July 2014.

As of 26 August 2014, marketing-authorisation holders have to pay a fee for assessment of PSURs.

The updated procedural guidance further clarifies how and to whom PSURs should be submitted. For nationally authorised medicines containing substances or a combination of active substances for which no single-assessment procedure has been established in the EURD list, the assessment of the PSUR will remain at national level.

PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. They are submitted by marketing-authorisation holders at defined time points following a medicine’s authorisation. 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, to decide if further investigations need to be carried out or to take action to protect the public from the risks identified such as updating the information provided for healthcare professionals and patients.