EMA safety committee assessed 85 medicine reports in October

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) published October figures after its 28 September–1 October meeting. Its monthly summary lists 85 single assessments of periodic safety update reports, 49 risk-management plans for centrally authorised medicines and 16 post-authorisation safety studies.

The committee reported nine safety signals: five were started and four were ongoing or concluded. EMA said the committee did not start or conclude any referral procedure at the meeting. These counts do not establish that a medicine caused harm or that a new restriction was imposed.

The agency says the monthly figures are based on the draft agenda. It defines a safety signal as information that may suggest a medicine-event association requiring further investigation; a signal alone is not proof of causation.