EU drug safety committee reviews nine signals, 85 PSURs at October meeting

• 2026-10-22
• Europe
• News Desk
• Source: European Medicines Agency https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-september-1-october

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee assessed nine safety signals, 85 periodic safety update reports and 49 risk management plans during its monthly meeting held from 28 September to 1 October, the Amsterdam-based agency said. The committee did not open or close any referral procedures during the session.

Key facts

What did the committee actually do?

• The PRAC assessed 9 safety signals: 5 were started and 4 were ongoing or concluded, according to EMA's October statistics based on the draft agenda.
• The committee issued 85 single assessments of periodic safety update reports: 55 recommendations for centrally authorised medicines only, 27 for nationally authorised medicines only and 3 covering both categories.
• Of 49 risk management plans for centrally authorised medicines, 10 were reviewed for new medicines and 39 for already authorised products.
• The committee reviewed 16 post-authorisation safety studies, covering 7 protocols and 9 sets of results from imposed and non-imposed studies.
• No referral procedures were started, ongoing or concluded during the meeting.

According to the agency's meeting highlights, the committee carried out its broad range of responsibilities for managing the safety of medicines. That work covered the assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

EMA describes a safety signal as information suggesting a new potentially causal link, or a new aspect of a known link, between a medicine and an adverse event that warrants further investigation. Such signals are drawn from sources including spontaneous reports, clinical studies and the scientific literature.

Periodic safety update reports are filed by marketing authorisation holders to describe worldwide safety experience with a medicine over a defined period after authorisation. Where products containing the same active substance or combination of substances are authorised in different EU member states, they are assessed jointly in a single procedure — a mechanism that pools safety evidence across the single market. Where do risk plans and safety studies fit?

Risk management plans are detailed descriptions of activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies must submit one to EMA when applying for a marketing authorisation, and the plans are updated throughout a medicine's lifetime as new information emerges.

Post-authorisation safety studies are carried out after a medicine has been authorised, either to obtain further information on its safety or to measure the effectiveness of risk-management measures. The committee assesses both the protocols — the organisational aspects of a study — and the results.

Referrals are the procedures used to resolve concerns over the safety or benefit-risk balance of a medicine or class of medicines. In a safety referral, the PRAC is asked by a member state or the European Commission to conduct a scientific assessment on behalf of the EU. What happens next?

The committee's agenda and a full list of topics discussed at the 28 September to 1 October meeting have been published, and information on referrals still under way is set out in the agency's ongoing referrals table. The PRAC, which meets monthly, will continue its assessments at its next scheduled session.

Source: European Medicines Agency