In the context of the EU pharma package 2010, the complexity of PSURs was substantially extended. PSURs are now focussing on the up-to-date signal evaluation and benefit-risk assessment of a product. Signal and risk evaluation needs to be performed not only for the reporting period, but also cumulatively for the time since granting of the marketing authorisation.
Therefore, the preparation of a PSUR ties up considerable human and financial resources within the industry without giving rise to any direct benefits in any other areas. Relevant parts of a PSUR are API specific, which means that the same general information (scientific and medical publications, announcements of Competent Authorities, originator documents etc.) has to be researched and processed by every authorisation holding company.
The BAH WiDi therefore decided to offer a high-quality PSUR compilation service at a reasonable price.
As described in the “Guideline on Good Pharmacovigilance Practices - Module IX - Signal Management”, signal evaluation is based on new information regarding the benefit-risk profile and efficacy. This information is extracted from all kinds of PV relevant sources. Customer specific data may also be evaluated and included in the PSUR.