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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


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