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Customized Or Pooled PSURs – Two Options

To address the different needs of individual firms regarding the writing of PSURs, the Pooling Project Pharmacovigilance offered two options for ordering PSURs.

Customized PSUR

When a customized PSUR is ordered, a complete PSUR in compliance with all regulatory requirements is written. The finished PSUR includes an Executive Summary, Introduction, Worldwide Market Authorisation Status, Update of regulatory authority or MAH actions taken for safety reasons, changes to reference safety information, patient exposure presentation of individual case history, studies, overall safety evaluation conclusion, and appendices (line listings, SmPC). The PSUR is delivered as one print copy and on digital copy (for editing).

The following components are included in the customized PSUR:

  • All narratives of case reports found in publications
  • Line listings of these case reports
  • Abstracts of published studies
  • Product-specific information, including direct reports, sales data and authorization dates, as well as line listings for the reports
  • Texts, analyses and summary tabulations, bibliography of publications
  • PSUR as a print-copy and an electronic file (for editing)

Pooled PSUR

The pooled PSURs are partial PSURs containing only literature-derived data (published case reports, line listings, etc.), as well as template text modules for the remaining parts of the document. Firms ordering such PSURs can then add the company-specific data in-house, an arrangement which significantly cuts costs and time spent on PSUR-writing.

In addition, the pooled PSURs are harmonised as to their data lock points and reporting periods for one active substance. Any firm that agrees to a harmonisation data can order such a pooled PSUR for an active substance. The costs are distributed among the participating firms. This also leads to a significant reduction in costs.

The following components are included in the pooled PSUR:

  • All narratives of case reports found in publications
  • Line listings of these case reports
  • Abstracts of published studies
  • Bibliography of publications
  • Template with formatting and text suggestions

When an active substance can be administered both locally and systemically, and a differentiation between the two routes seems pharmacologically necessary, the pooled PSURs are offered in a “systemic” and a “local” version.

To give you an idea of the structure and appearance of the pooled PSUR (template), please click on the menu item "Demo-Template" to view images of parts of such a PSUR.