The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.

Periodic Safety Update Report

Periodic Safety Update Reports are pharmacovigilance documents submitted to the Competent Authorities, which provide an evaluation of the risk benefit balance using the worldwide safety data collected in connection to a medicinal product. Marketing Authorization Holders and Competent Authorities use this evaluation to conclude on the safety and efficacy profile of the medicinal product and 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.

Periodic Safety Update Report in the European Union/EEA

In the EU/EEA, PSURs should follow a specific format (PBRER) and submission schedule.

The frequency with which the PSURs are to be submitted shall be specified in the marketing authorization. The dates of submission according to the specified frequency shall be calculated from the date of the authorization.

The Agency (European Medicines Agency) carries out single assessments of related PSURs (PSUSA) for medicines containing the same active substances or combinations of active substances in order to harmonize and strengthen the safety and benefit-risk review of medicines across the European Economic Area. Marketing authorization holders of branded products as well as generic products are expected to submit PSURs under this single assessments process, using the EURD list as reference for submission dates and DLPs (data lock points).

Latest Glossary Definitions

Efficacy-Effectiveness Gap

The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.

Briefing Book (or briefing materials)

Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.

Clinical Impact

The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.

Commercially Confidential Information (CCI)

In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.

Clinical Evaluation Report (CER)

Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.

CE-Marking Technical File

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.

Comparative Effectiveness Research (CER)

The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).

Core Value Dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.

Core Reimbursement Dossier

A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.