Marketing Authorisation Holders (MAHs) are required to monitor scientific and medical literature and to report individual cases of suspected adverse reactions for medicinal products, for which they hold a Marketing Authorisation in the EEA.
Marketing authorisation holders (MAH) are expected to perform a:
- Global literature search, through a systematic literature review of widely used reference databases (e.g., Medline, Excerpta Medica or Embase).
- Local literature search, in local journals in countries where the medicinal product has a Marketing Authorization.
The literature review includes literature on the benefit/risk profile of the product and not just individual cases of suspected adverse reactions (also referred to as individual case safety reports (ICSRs)). It should also identify any emerging safety issues (ESI).
Suspected adverse reactions are valid for reporting if there is a reasonable suspected causal relationship between the event and the suspected medicinal product and the 4 minimum criteria for reporting are met:
- identifiable patient
- identifiable reporter
- suspected reaction
- suspect medicinal product
For regulatory reporting purposes the clock starts (day zero) on the day when the physical local journal is received by the Marketing authorisation holder/Applicant.
Awareness of a publication includes any personnel of the MAH, or third parties with contractual arrangements with the MAH.
The medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
It is intended that the literature search should start as soon as an application for a Marketing Authorisation is submitted and continue for as long as the authorisation is in force.
MAH are required to monitor the safety profile and the risk-benefit balance of their medicinal products.
Only medicines whose benefits are judged to be greater than its risks are authorized for marketing by the authorities.
Notes:
- ICSR: a document providing information related to an individual case of a suspected side effect due to a medicine.
- Safety signal: information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature.
Sources: