Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025
New safety information for healthcare professionals
Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecally
PRAC agreed on a direct healthcare professional communication (DHPC) to remind healthcare professionals that extreme caution should be taken when handling and giving injectable tranexamic acid to ensure it is only given intravenously (into a vein).
Full article at source: European Medicines Agency (EMA)
ICMRA Summit 2025: EMA concludes its two mandates as chair
At the ICMRA Summit 2025, international medicines authorities addressed the regulators’ role as communicators of reliable, evidence-based, scientific information and the importance of trust and transparency.
Full article at source: European Medicines Agency (EMA)
EMA partners with content creators to promote safe and responsible use of GLP-1 medicines
Partnering with content creators
The Agency carefully selected content creators from seven different Member States of the European Union (EU) to ensure a balanced geographical coverage.
Full article at source: European Medicines Agency (EMA)
First treatment for serious chronic lung disease
EMA has recommended granting a marketing authorisation in the European Union (EU) for Brinsupri (brensocatib) 25 mg tablets, for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older who have had two or more exacerbations (flare-ups) in the prior 12 months.
Full article at source: European Medicines Agency (EMA)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its October 2025 meeting.
Full article at source: European Medicines Agency (EMA)
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation from Zoetis Belgium for Lenivia (izenivetmab), for the reduction of pain associated with osteoarthritis in dogs.
Full article at source: European Medicines Agency (EMA)
EMA Management Board: highlights of October 2025 meeting
EMA mid-year report 2025
EMA presented results and achievements of its operations for the first half of 2025.
Full article at source: European Medicines Agency (EMA)
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September – 2 October 2025
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
Full article at source: European Medicines Agency (EMA)
Advice on end of year submission dates for type I variations in 2025
EMA is advising marketing authorisation holders to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025.
Full article at source: European Medicines Agency (EMA)
A path to better include patients’ perspectives in the regulation of medicines
EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else.
Full article at source: European Medicines Agency (EMA)
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