According to the GVP Module VI “Management and reporting of adverse reactions to medicinal products” and GVP Module IX „Signal management“ MAHs are expected to maintain awareness of relevant publications through a systematic literature review of a widely used reference database (for example MEDLINE) not less frequently than once a week.
Literature search meeting the requirements set out in the GVP modules Module IX “Signal Management” and VI “Management and reporting of adverse reactions to medicinal products” includes:
- Weekly literature search of the scientific and medical literature
- Identification of case reports of adverse reactions and signals/Emerging Safety Issues (ESIs)
- Retrieval of scientific medical publications with relevance to drug safety or benefit-risk-balance like systematic reviews, meta-analyses, reports and studies on the efficacy and/or safety of the medicinal product
- Continuous benefit-risk evaluation.
Identified unlisted ADRs or risks are handled as potential signals and are further analysed in the process of Signal Management and CoBRA®. Changes of the benefit-risk balance will be identified immediately and necessary countermeasures may be taken instantly. Our synergistic approach allows us to use the results of literature search and Signal Management and CoBRA®, respectively, for the compilation of PSURs.