How the Safety of Medicinal Products Is Monitored – The Spontaneous Reporting System

Medicinal products are intended to cure or alleviate diseases and, in some cases, even prevent illness or symptoms from occurring at all. However, the use of medicinal products and vaccines can also lead to side effects. Rare and very rare adverse events can still be detected after reaching stages such as authorisation and market launch once a very large number of people have been vaccinated or treated. That is why the continuous monitoring of medicinal products carries on even after authorisation. An important component of medicinal product monitoring is the spontaneous reporting system. Reports of side effects are recorded in the spontaneous reporting system. The reports are "spontaneously" documented and reported outside of systematic examinations. There may be valuable indications (signals) of rare, hitherto unknown side effects. 

The Paul-Ehrlich-Institut – responsible for monitoring the safety of vaccines and biomedicines in Germany – has created two short explanatory videos demonstrating how reporting and recording suspected side effects contributes to the safety of medicinal products and how suspected case reports are assessed.

The Spontaneous Reporting System – How Reporting and Recording Suspected Side Effects Contributes to the Safety of Medicinal Products

The Spontaneous Reporting System – How Reports of Suspected Side Effects Are Assessed