EMA CHMP Agendas & Minutes

EMA CHMP Meeting: 5 New Medicines, 13 Indication Extensions Recommended

The EMA's CHMP recommended five new medicines for approval and extensions of therapeutic indications for 13 existing medicines at its March 2026 meeting. The committee also confirmed a refusal for a marketing authorisation change and noted the withdrawal of an application for a new Alzheimer's treatment.

EMA CHMP Meeting Agenda March 2026

The European Medicines Agency (EMA) has published the agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for March 23-26, 2026. The agenda outlines discussions on various medicinal products, including initial applications, oral explanations for pre-authorisation, re-examination, and post-authorisation procedures.

EMA CHMP Meeting Agenda March 2026

The European Medicines Agency (EMA) has published the agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for March 23-26, 2026. The agenda outlines 23 procedures, including annual reassessments and Periodic Safety Update Reports (PSURs), for review by the committee.

EMA CHMP Agenda: Hetlioz for Smith-Magenis Syndrome

The European Medicines Agency (EMA) has published the agenda for an extraordinary CHMP meeting on March 16, 2026. The agenda includes discussions on the re-examination procedure for Hetlioz (Tasimelteon) for Smith-Magenis Syndrome, involving oral explanations and variations to marketing authorisations.

EMA CHMP Meeting Minutes July 2025

The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.

EMA CHMP Meeting Agenda February 2026

The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.