The European Medicines Agency (EMA) has published the agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for 18-21 May 2026. The document, released on 18 May 2026, outlines the items to be discussed during the four-day session, including applications for new marketing authorisations, extensions of indications, and post-authorisation procedures.
The CHMP is responsible for evaluating medicinal products for human use in the European Union, providing scientific opinions on whether they meet the required quality, safety, and efficacy standards. The agenda covers a range of therapeutic areas, with several products under review for conditions such as oncology, neurology, and rare diseases.
Key items include the assessment of new active substances, generics, and biosimilars, as well as updates on ongoing safety reviews. The committee will also discuss proposed changes to existing marketing authorisations, including variations and line extensions.
Stakeholders affected by the CHMP's decisions include pharmaceutical companies seeking EU-wide approval, healthcare professionals, and patients awaiting new treatment options. The outcomes of the meeting will influence market access and prescribing practices across the EU.
Following the meeting, EMA will publish the CHMP meeting highlights and any adopted opinions, which will be forwarded to the European Commission for final decision on marketing authorisations.