EMA Committee for Medicinal Products for Human Use – Meeting Highlights – November 2026

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has published the highlights from its meeting held in November 2026.

The CHMP is the European Medicines Agency’s (EMA) scientific committee responsible for evaluating the quality, safety, and efficacy of human medicines. The committee meets once a month and is composed of scientific experts from all 27 EU Member States as well as Iceland, Lichtenstein and Norway. HPRA experts act as the representatives from Ireland. 

The CHMP issues an opinion on whether a medicine should be granted an EU-wide centralised marketing authorisation (i.e., license). This opinion is based on a rigorous review of scientific and regulatory information to ensure the benefits of taking a medicine outweigh the known and potential risks. It is the European Commission who ultimately grants a centralised marketing authorisation based on the CHMP’s opinion. 

Visit the EMA website for more information on the Committee for Medicinal Products for Human Use (CHMP).

Whether a centrally authorised medicine is marketed (i.e. placed on sale) in Ireland is at the discretion of the company which holds the marketing authorisation. The HPRA and EMA have no role in the marketing or pricing and reimbursement of medicines in Ireland.

New medicines:

• Aumseqa (aumolertinib), for the treatment of non-small cell lung cancer.
• Baxfendy (baxdrostat), for the treatment of insufficiently controlled hypertension.

• Zybrivo (sintilimab), for the treatment of non-squamous non-small cell lung cancer in adults. 

Biosimilars:

• Garzulys (insulin aspart), for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
• Donrafylix (insulin aspart), for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Generics:

• Fondaparinux sodium Evumed (fondaparinux sodium), for the prevention of venous thromboembolic events, and the treatment of deep vein thrombosis, pulmonary embolism, unstable angina and myocardial infarction in adults.
• Ruxolitinib Krka (ruxolitinib), for the treatment of myelofibrosis and polycythaemia vera in adults, and treatment of Graft-versus-host disease in adults and children.

Further information is available from the November 2026 CHMP meeting highlights.