The “4. Bekanntmachung der Bundesoberbehörde zur Anzeige von Nebenwirkungen und
Arzneimittelmissbrauch” of April 2005 delineates the requirements for
literature research for pharmacovigilance purposes in germany.
Section 3.1.2 states the following:
Screening of literature for cases of adverse reactions should be based on a
specific substance (not product).
At least one relevant database must be screened.
The 15-day deadline for reporting relevant cases to the competent authorities
begins with the day the marketing authorisation gains knowledge of the case.
The Pooling Project Pharmacovigilance of the BPI Service GmbH helps
pharmaceutical firms to comply with the regulatory requirements for literature
research on a continuous basis without draining company resources.
The Literature Research and Assessment function within the Pooling Project
Pharmacovigilance is based on the use of a joint literature database.
Because the research, assessment and database access is collaborative, the
costs of these activities per firm become less as more participants take
advantage of the service.
The Pooling Project screens more than 12 relevant databases (including Medline
and Toxline) The literature found in these screenings is assessed for relevance
and then saved to the database. CIOMS forms are generated and filled out for
cases which are assessed as “Potential Cases”, including a “Recommended
assessment of drug relation to adverse reaction”. These can be accessed as
digital files to be downloaded and edited.
A line listing is available for all cases that appear relevant to a Periodic
Safety Update Report (PSUR). As with the CIOMS form, these may also be
downloaded for a small fee. Studies which are considered relevant for a PSUR
have no line listing attached, but are posted in the database to facilitate