Outcomes of imposed non-interventional post-authorisation safety studies
HumanMedicinesPharmacovigilance
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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.
An EU competent authority may impose a non-interventional PASS, either as a condition of marketing authorisation (category 1) or as a specific obligation in a conditional marketing authorisation or a marketing authorisation under exceptional circumstances (category 2). For more information, see Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3).
EMA's scientific committees (PRAC and CHMP) and the CMDh carry out the assessment of PASS study protocols and final study results. For more information, see PASS: questions and answers.
The outcomes of imposed non-interventional PASS final study results assessments for active substances found only in centrally authorised medicines are published as part of each medicine's European public assessment report (EPAR).
The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the European Commission.
Protocols and abstracts of results of imposed non-interventional PASS are publicly available in the EU PAS Register on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website.
Outcomes for active substances contained in nationally authorised products
The table below lists the outcomes of imposed non-interventional PASS final study results for active substances contained in nationally authorised medicines, by alphabetical order.
When the assessment of PASS final study results for a nationally authorised product leads to a variation of marketing authorisations, marketing authorisation holders for products containing the active substance concerned by the PASS final report should submit a variation to align their marketing authorisation with the adopted outcome.
Marketing authorisation holders for products containing the same active substance but not concerned by the PASS final report should consider whether the proposed changes to product information apply to their products.