Date of Publication: 09-Feb-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has published its recommendations and safety signals adopted at the 12–15 January 2026 meeting, providing updated assessments of emerging safety information for medicines authorised in the EU. These recommendations reflect PRAC’s ongoing monitoring of post-authorisation safety data, periodic safety update reports (PSURs), risk management plans (RMPs), and post-authorisation safety studies.
Industry Impact
PRAC’s safety signal assessments are critical for Marketing Authorisation Holders (MAHs), safety and PV teams, and regulatory strategists across the pharmaceutical industry. The recommendations:
- Highlight emerging safety issues requiring closer evaluation or additional risk-mitigation measures
- Inform potential updates to product information and regulatory actions
- Guide proactive pharmacovigilance planning and compliance
- Support a risk-based approach to ongoing benefit-risk evaluation
Staying aligned with PRAC signals and recommendations helps industry stakeholders maintain up-to-date safety profiles and anticipate regulatory expectations in the EU market.
KEYWORDS: Pharmacovigilance, Risk Management, Post-Authorisation
REFERENCE: https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-12-15-january-2026-prac-meeting_en.pdf