Literature Screening

Marketing authorisation holders must regularly review the scientific literature for reports of suspected cases relating to their active substances. A published case is reportable like any other — the clock starts on the day on which the publication became accessible to the company.

Literature screening is the area in which gaps go unnoticed the longest. Anyone who searches only globally in the major databases misses local journals; anyone who looks only once a quarter has already missed the deadline when they find the case. Both only come to light during the inspection — and then retrospectively across the entire inspection period.

Every marketing authorisation holder. Particularly those with marketing authorisations in several countries, with active substances on which much is published, and those that have so far had screening done on the side.

• GVP Module VI — monitoring of the medical literature by the marketing authorisation holder
• Reporting deadlines of 15 and 90 days respectively from the date the publication became accessible
• Distinction from the EMA’s Medical Literature Monitoring for selected active substances
• Obligation to document the search strategy, interval and result — including when nothing is found

• Regular global searches in Medline and Embase
• Local searches in German-speaking countries
• Local searches in further countries in and outside the EU
• Documented search strategy, fixed interval, traceable assessment of hits
• Transfer of relevant publications into single case processing

Through a network of carefully selected partners, VigiPRO covers not only the global search but also local sources in further countries in and outside the EU — the area that a purely global search systematically fails to reach.