The Medical Literature Review and Monitoring of the EMA
The review of medical literature and searching of relevant databases is an important factor in identifying any individual case safety reports (ICSRs) and safety study reports relating to:
- Suspected adverse reactions to a medicine
- Special situations such use during pregnancy or off-label use
- Lack of therapeutic efficacy
- Identification of falsified medicinal products and any resulting adverse events (AE)
- Suspected transmission of an infectious agent via a medicinal product .