Our missions

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:

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.

Monitoring medicines

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ANSM receives or detects potential signals from various sources (pharmacovigilance, medication error and misuse reports, articles from monitoring the scientific literature, pharmacovigilance surveys conducted by RPCs, etc.). We categorise each signal according to its level of risk and analyse it by cross-referencing the data at our disposal in order to confirm or refute it. Discussions are held with the Regional Pharmacovigilance Centre (CRPV) network, but also with patient representatives and healthcare professionals throughout the signal evaluation process.

Signal identification and processing

Managing medication errors

In addition, we establish an enhanced surveillance programme based on a preliminary risk analysis of certain situations or products, without there necessarily being an identified signal. Various tools are used to perform this enhanced surveillance: pharmacovigilance surveys, statistical signal detection, monitoring of surveillance databases, etc.

Enhanced surveillance of medicines

This continuous surveillance enables ANSM to implement new or supplementary measures, if necessary, in addition to those already in place.

Risk-reduction measures

Finally, ANSM oversees medicine advertisements before they are published.

Control over medicine advertising

Our missions

Ensuring the safety of health products

Monitoring medicines