PRAC Recommendations on Safety Signals

AIFA Drug Safety Signals

Published March 9th, 2026

Detected March 13th, 2026

Summary

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.

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What changed

The European Medicines Agency (EMA) has published recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting held February 9-12, 2026. These recommendations address specific safety signals identified for various medicinal products, including Chikungunya vaccine and Omalizumab. Marketing Authorisation Holders (MAHs) are directly informed of actions required, which may include submitting supplementary information by specific deadlines (e.g., February 23, 2026, for Chikungunya vaccine) or assessing risks in future Periodic Safety Update Reports (PSURs) by March 31, 2026, for Omalizumab.

MAHs must ensure their product information is updated according to current scientific knowledge and PRAC recommendations. For Centrally Authorised Products (CAPs), recommendations for product information updates have been endorsed by the Committee for Medicinal Products for Human Use (CHMP). For Nationally Authorised Products (NAPs), National Competent Authorities (NCAs) will oversee adherence. Failure to comply with these recommendations could lead to regulatory action and potential impacts on product authorisation. MAHs are advised to refer to EMA guidance for procedural aspects and submission requirements.

What to do next

Review PRAC recommendations for specific signals applicable to your products.
Submit supplementary information or update product information as required by the deadlines.
Consult EMA guidance for procedural requirements related to signal management and variation submissions.

Source document (simplified)

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged. 9 March 2026 Pharmacovigilance Risk Assessment Committee (PRAC) Adopted at the 9-12 February 2026 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 9-12 February 2026 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers). PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to take action according to the PRAC recommendations. When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States. MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations published on the European Medicines Agency (EMA) website (currently acting as the EU medicines webportal). For CAPs, at the time of publication, PRAC recommendations for update of product information have been agreed by the CHMP at their plenary meeting (23-26 February 2026) and corresponding variations will be assessed by the CHMP. For nationally authorised medicinal products, it is the responsibility of the National Competent Authorities (NCAs) of the Member States to oversee that PRAC recommendations on signals are adhered to. Variations for CAPs are handled according to established EMA procedures. MAHs are referred to the available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures) are handled at national level in accordance with the provisions of the Member States. Expected publication date. The actual publication date can be checked on the webpage dedicated to PRAC recommendations on safety signals. The relevant EPITT reference number should be used in any communication related to a signal.

Page 2/3 The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of PRAC recommendations on signals (e.g. submission requirements, contact points, etc.) please refer to the Questions and Answers on signal management.

Page 3/3 1. Recommendations for update of the product information Not applicable 2. Recommendations for submission of supplementary information INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Chikungunya vaccine (live) New aspect of the known risk of aseptic meningitis (20250) Dirk Mentzer (DE) Supplementary information requested (submission by 23 February 2026) Valneva Austria GmbH Omalizumab Acquired haemophilia (19385) Mari Thörn (SE) Assess in the next PSUR (submission by 31 March 2026) Novartis Europharm Limited, Celltrion Healthcare Hungary Kft. 3. Other recommendations INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Risankizumab Pemphigoid (20192) Liana Martirosyan (NL) Routine pharmacovigilance AbbVie Deutschland GmbH & Co. KG