EMA Issues Guidance on Periodic Safety Update Reports

On April 6, 2017, the European Medicines Agency (EMA) released two guidance documents to help improve the process of assessing periodic safety update reports (PSURs). Marketing authorization holders submit PSURs, which evaluate the benefits and risks of a medication, to the agency after authorization. EMA uses the reports to assess the benefit-to-risk balance of the medication to determine the continued safety of the drug. Products that contain the same API or combination of APIs are assessed jointly in a single assessment procedure.

The assessment process was streamlined to “ensure that all the evidence generated about medicines containing the same active substance is reviewed at the same time by one authority, resulting in consistent safety information,” EMA stated in a press release. Explanatory Note to GVP Module VII addresses concerns that companies have expressed during the two years since the PSUR single assessment process started in 2015. The guidance discusses several topics, such as the scope of information to be included in PSURs, changes to therapeutic indications, information for generic drugs, reference product information, safety actions taken by countries, patient exposure, and signal evaluation.

Assessors' Questions and Answers (Q&A) Guidance on PSUR Single Assessment (PSUSA) gives assessors guidance on the evaluation process of PSURs. The agency is planning joint training in 2017 for both industry and European Union authorities on the implementation of the single assessment process.