New guidance and process improvement for periodic safety update reports
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement.
PSURs are reports that evaluate the benefit-risk balance of a medicine as evidence is gathered in clinical use. 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 linked to a medicine or if the balance of benefits and risks of a medicine has changed. Based on this information, EMA decides whether further investigations are needed or whether measures have to be taken to protect public health, generally via updated product information for healthcare professionals and patients. If medicinal products contain the same active substance or the same combination of active substances, the related PSURs will be jointly assessed in a single assessment procedure.
Two new documents aim at improving the safety information and benefit-risk assessment of medicines in the context of the periodic safety update single assessment (PSUSA): ‘Explanatory note to GVP Module VII’ and ‘Assessors’ questions and answers (Q&A) guidance on PSUR single assessment (PSUSA)’. The explanatory note addresses issues that have been raised by companies during two years of running the single assessment process. The Q&A document guides assessors throughout the evaluation process of PSURs to improve standards and increase consistency.
The Agency has carried out single assessments of periodic safety update reports for nationally authorised medicines containing the same active substances or combinations of active substances since 2015. Before that, PSURs for medicines containing the same active substance or the same combinations were submitted for assessment by their respective marketing authorisation holders to different national competent authorities at different times. The introduction of single assessments helped to streamline the process and 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.
The PSURs submitted by marketing authorisation holders are assessed by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) together with a leading assessor from one nominated national authority for medicines regulation, the so-called lead Member State. The recommendations made during the assessment are legally binding, applicable to all Member States and implemented across the European Union (EU). The joint assessment helps to optimise use of resources between national competent authorities.
Single assessments of periodic safety update reports are a key post marketing regulatory tool to ensure patients receive up-to-date information on the safety of medicines. PSURs provide regular opportunities for monitoring medicines in a public health space that covers nearly 500 million people. Patients and healthcare professionals benefit from it because they have timely access to safe, effective and high quality medicines.
EMA plans to organise joint training in the second quarter of 2017 for the pharmaceutical industry and EU national competent authorities to support the implementation of the optimised single assessment process.