According to §63b of the German Pharmaceutical Law (Arzneimittelgesetz – AMG),
the marketing authorisation holder is required to submit to the national
competent authorities a Period Safety Update Report (PSUR) in regular
intervals. The PSUR-writing service of the Pooling Project Pharmacovigilance is
central part of the comprehensive service package offered by the project.
The goal is to reduce the costs accrued by a pharmaceutical firm in writing
PSURs while still complying with all regulatory requirements and fulfilling the
highest quality standards. The basis of the project’s approach to PSUR-writing
is the pooling effect, which allows a reduction in the costs per firm in
proportion to the number of participating firms. The PSURs are written
incompliance with the BPI Service Standard Operation Procedures (SOPs).
Depending on the individual preferences and needs of the participating firms,
either a customized PSUR (including all company- and product-specific data, as
well as literature) or a pooled PSUR (including only literature-derived data)
may be ordered. The pooled PSUR is a template with pre-formatted tables and text
suggestions to help the firms complete it in-house.
When a customized PSUR is ordered, the firm receives a PSUR with all relevant
data for their product(s), including company-specific data (such as spontaneous
reports, sales numbers, etc.) and literature-derived data (published case
reports and studies), including narratives line listings, summary tabulations,
a publication list.
As an alternative to the customized PSUR, the Pooling Project Pharmacovigilance
offers a pooled PSUR. These PSURs include all relevant data derived from the
literature research within the project for a particular substance. This
includes narratives, line listings, summary tabulations and a publication list
for all literature case reports, as well published studies. The rest of the
template contains pre-formatted text modules that can easily be edited to
include the company-specific information in-house.
To maximize the pooling effect and resulting reduction in costs for each firm,
the PSURs are offered for harmonised data lock points and reporting periods.
These harmonized data lock points are currently based on the participating
firms’ individual data lock points, but will be based on the EU Harmonized
Birth Dates in the future, once these are published.
A tool has been programmed to efficiently extract the data from the literature
database, thereby cutting costs still further.