Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October

2 Octubre 2026

PRAC carried out its broad range of responsibilities for managing the safety of medicines

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. 

The Committee did not start or conclude any referral procedures. Information on ongoing safety referrals is provided in the ‘Ongoing referrals’ table below. 

Information on all topics discussed by the PRAC is available in the agenda.

Agenda

Agenda of the PRAC meeting 28 September - 1 October 2026

Draft Reference Number: EMA/PRAC/204838/2026

PRAC statistics: October 2026

Monthly figures for PRAC outcomes based on the draft agenda.

© European Medicines Agency

PRAC statistics: Text version

October 2026 statistics:

• 9 safety signals: 5 started, 4 ongoing and concluded
• 85 periodic safety update reports (PSURs) single assessments: 55 recommendations for centrally authorised medicines only, 27 recommendations for nationally authorised medicines only, 3 recommendations for PSURs including both centrally and nationally authorised medicines
• 49 risk management plans (RMPs) for centrally authorised medicines: 10 RMPs reviewed for new medicines, 39 RMPs reviewed for authorised medicines
• 16 post-authorisation safety studies (PASSs): 7 protocols for imposed and non-imposed studies reviewed, 9 results from imposed and non-imposed studies reviewed
• 0 referrals: 0 started, 0 ongoing or concluding

Glossary

• Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under 'Signal management'.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under 'Periodic safety update reports: questions and answers'.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans'.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under 'Post-authorisation safety studies'.
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.