EMA publishes new guidance and process improvement for PSURs

The European Medicines Agency (EMA) has issued an “Explanatory note to GVP Module VII”, which contains new guidance and recommendations on the process for periodic safety update reports (PSURs).

 

The explanatory note and another new document, ‘Assessors’ questions and answers (Q&A) guidance on PSUR single assessment (PSUSA)’, seek to improve the safety information and benefit-risk assessment of medicines via a PSUSA.  The explanatory note addresses issues that have been raised by companies during two years of the single assessment process.  The Q&A document is for assessors, to guide them throughout the evaluation process of PSURs to improve standards and consistency.

The single assessments ensure that all relevant evidence on medicines containing the same active substance is reviewed at the same time by one authority, resulting in consistent safety information.  PSURs are assessed by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) together with a leading assessor from one nominated national authority, the so-called lead Member State.  Recommendations made during the assessment are legally binding and applicable to all EU Member States.

 

The EMA intends to run joint training in the second quarter of this year for the pharmaceutical industry and EU national competent authorities to support the implementation of the improved single assessment process.

 

Click here to read the EMA announcement and access two guidance documents.