Aggregate Reporting

Producing and delivering
Periodic Reports in Pharmacovigilance

What is an Aggregate Report?

The periodic reporting of aggregate safety reports provides National Competent Authorities (NCAs) with a comprehensive overview of the safety profile of a drug, based on the collated evidence to date. They also provide assurance that the Marketing Authorisation Holder is continuously monitoring and critically assessing the benefit-risk balance of the product and taking appropriate action where new risks or changes to known risks are identified. The international standard for periodic reports follows reporting guidelines set by the International Conference on Harmonisation (ICH). 


For products under development in interventional clinical trials, the aggregate report is the Development Safety Update Report (DSUR; ICH-E2F). For products with a marketing authorisation, the Periodic Benefit-Risk Evaluation Report, also commonly referred to as the Periodic Safety Update Report (PSUR), is used. These reports cover drug products, vaccines and combination therapies including drug-device products. While the DSUR is an annual report, the frequency of submission of the PSUR is usually dependent on the receiving NCA, time since authorisation, other products on the market with the same active ingredient, use in vulnerable populations and other known or potential risks with use of the product.

Our PV team are highly experienced in the delivery of aggregate reports, such as Development Safety Update Reports (DSURs), IND Safety Reports, Periodic
Safety Update Reports / Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs), and Periodic Adverse Drug Experience Reports (PADERs).

Preparation and submission of aggregate reports  

QVigilance can work in conjunction with the customer and can help support the document preparation and submission of aggregate reports by providing the following services:

  • Development and maintenance of an aggregate reporting schedule

  • Planning of a preparation and review schedule with agreed timelines for all parties involved in the preparation and review, including requesting and collating information

  • Generation of listings from the safety database

  • Preparation of line-listings and tabulations for inclusion in the report

  • Drafting, medical review, formatting of reports

  • Submission of reports, including registration and submission of reports via centralised repositories for aggregate reports if required, including submission via PSUR centralised repository, Common European Submission Portal (CESP) and other portals for electronic submission

  • Submission of reports by courier service in either paper or CD format

  • Provision of quality metrics

  • Management of assessment reports and responding to any questions that may arise from authorities


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