All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored to ensure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. This monitoring is called pharmacovigilance.
Pharmacovigilance activities include:
- Collecting and managing data on the safety of medicines.
- Looking at the data to detect “signals” (any new or changing safety issue).
- Evaluating the data and making decisions with regard to safety issues.
- Pro-active risk management to minimise any potential risk associated with the use of the medicine.
- Acting to protect public health (including regulatory action).
- Communicating with and informing stakeholders and the public.
- Audit, both of the outcomes of action taken and of the key processes involved.
For more information about pharmacovigilance on the ec.europa.eu website