Every health product provides benefits but also poses risks. This is referred to as the “benefit-risk balance”. Our mission is to ensure that this balance is positive, i.e. that the benefits for the patient are greater than the risks, throughout the life cycle of the health product.
For this reason, ANSM therefore monitors health products constantly, with the aim of continually checking that the benefit-risk balance remains positive post-marketing, in real life, and reinforcing the safety of heath products if needed through various measures.
This process is based on:
For this reason, ANSM therefore monitors health products constantly, with the aim of continually checking that the benefit-risk balance remains positive post-marketing, in real life, and reinforcing the safety of heath products if needed through various measures.
This process is based on:
- Recording and analysing adverse events reports submitted by healthcare professionals, patients and users, via the “vigilance” system and targeted and enhanced surveillance of certain products;
- Conducting epidemiological studies on health products;
- Conducting literature reviews of studies conducted in France and internationally.
