Medicine safety refers to the continuous and systematic monitoring of the safety of medicines.
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The body of knowledge on the safety of a particular medicine is not considered complete upon authorisation. This is primarily because clinical trials include a relatively small number of patients. It is generally not possible to detect rare or extremely rare adverse events during clinical trials. New findings on the safety of a medicine can be discovered after marketing authorisation and can result in a new benefit-risk profile for that medicine.
The Medicine Safety Division of the Paul-Ehrlich-Institut (PEI) collects and evaluates reports of adverse medicinal events for human and animal vaccines and biomedicines in Germany. Institute experts take any measures deemed necessary for the protection of patients or animals.
Pharmaceutical companies, in consultation with the competent higher federal authority, are required to promptly share any safety-relevant information with doctors and pharmacists (‘Dear Doctor Letters’, Rote-Hand-Briefe).
Anyone can report a suspected adverse event associated with a medicine. Marketing authorisation holders, medical professionals, affected patients, and patients’ family members have access to specific reporting channels:
Updated: 08.08.2022
