Literature research

According to the GVP Module VI (Management and reporting of adverse reactions to medicinal products) marketing authorisation holders should take appropriate measures in order to collect and collate all reports of suspected adverse reactions associated with medicinal products for human use originating from unsolicited or solicited sources.

MAHs are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. According to Appendix 2 (Detailed guidance on the monitoring of scientific and medical literature) of GVP Module VI literature searches should be conducted for all products with a marketing authorisation, irrespective of commercial status. It would therefore be expected that literature searching would start on submission of a marketing authorisation application and continue while the authorisation is active.

Reports of suspected adverse reactions from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, should be reviewed and assessed by marketing authorisation holders to identify and record individual case safety reports (ICSRs) originating from spontaneous reports or non-interventional post-authorisation studies.

We take over the literature search meeting the requirements set out in the GVP module VI including weekly literature search of the scientific and medical literature, retrieval of scientific medical publications with relevance to drug safety or benefit-risk-balance. In addition, at your request we also take over the identification of events, which fall within the definition of reportable valid ICSRs.

In addition, we offer literature research in questions related to the efficacy, safety, pharmacology, pharmacokinetics and toxicology of medicinal substances. Our services also include evaluation of the literature and supply with the bibliographic data and abstracts.