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

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

Latest recommendations for authorisation 

Following the October 2026 CHMP meeting, the following medicines received a positive opinion and were recommended for approval:

New medicines

• Rasonque (daraxonrasib), for the treatment of adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have received at least one previous treatment. This recommendation follows a phased review of data on Rasonque, which was identified as a high-priority medicine under EMA’s Cancer Medicines Pathfinder project, given its potential to address this unmet medical need. More details on the authorisation of Rasonque is available on the EMA website. 
• Foundayo (orforglipron), for the treatment of obesity and type 2 diabetes mellitus in adults.
• Kizfizo (temozolomide), for the treatment of adults with glioblastoma multiforme (an aggressive type of brain tumour) and children with malignant glioma (brain tumours). This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product, and in part on new data.
• Yuviwel (navepegritide), for the treatment of achondroplasia in children.

Biosimilars

• Fovlussea (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.
• Neuzafy (filgrastim), for the treatment of neutropenia in adults and children.

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