EMA – Outcomes of imposed non-interventional post-authorisation safety studies
The European Medicines Agency (EMA) publishes the outcomes of final study results of imposed non-interventional post-authorisation safety studies (PASS) for medicines authorised in the European Union (EU).
The rules on submitting results for imposed non-interventional PASS fall under Art 107q of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use.
A PASS is a study carried out after a medicine has been authorised to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures. A PASS is non-interventional if:
- the medicine is prescribed in the usual way in accordance with the terms of the marketing authorisation;
- deciding how to treat the patient is based on current practice and not a trial protocol;
- the prescription of the medicine is separate from the decision to include the patient in the study;
- patients do not undergo additional diagnostic or monitoring procedures;
- data analysis uses epidemiological methods.
More information on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (4 octobre 2024). EMA – Outcomes of imposed non-interventional post-authorisation safety studies. ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/12f6z





