Ema Chmp Agenda, Agenda and minutes The agenda of the Decem
- Ema Chmp Agenda, Agenda and minutes The agenda of the December 2025 CHMP meeting is published on EMA's website. The CHMP is due to issue opinions for the following technologies: Vanzacaftor with tezacaftor and deutivacaftor Levacetylleucine Trastuzumab Denosumab Diflunisal Givinostat Resminostat Octreotide acetate Sepiapterin Teprotumumab Clascoterone Zanidatamab Read CHMP Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. It includes sections on oral explanations, initial applications, marketing authorisation extensions, and various procedures related to medicinal products. Note on access to documents EMA's Executive Director Emer Cooke and CHMP Chair Bruno Sepodes reflect on the significance of 30 years of the centralised procedure for medicines authorisation. 1 The CHMP PROM is a meeting to discuss CHMP organisational matters and other topics in preparation for the CHMP Plenary meeting. It is a virtual meeting, which usually takes place on Monday before the CHMP Plenary meeting. Note on access to documents The revision of these vaccines is in line with the recommendations issued by EMA’s Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variants for the 2024/2025 vaccination campaign. More information on the Committee for Medicinal Products for Human Use can be found on the website of the European Medicines Agency (EMA). CHMP statistics Key figures from the March 2025 CHMP meeting are represented in the graphic below. Note on access to documents EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting. The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines. Jun 17, 2025 · The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has outlined its agenda for June 2025, focusing on a series of variation assessments critical to the maintenance and enhancement of various medicinal products across the market. Minutes of the meeting will be published in the coming weeks. Agenda and minutes The agenda of the October 2025 CHMP meeting is published on EMA's website. For more information on this recommendation, see the public health communication in the grid below. Agenda and minutes The agenda of the April 2025 CHMP meeting is published on EMA's website. Note on access to documents EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. The committee recommended granting a marketing authorisation for Fylrevy (estetrol), a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on - going procedures for which a final decision has not yet been ado pted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. This brings the total number of medicines recommended for approval in 2024 to 114. Additionally, it notes that some information is commercially confidential EMA advises about risks of using weight loss medicine Mysimba with opioids EMA recommends that the weight loss medicine Mysimba (naltrexone/ bupropion) must not be used in people receiving treatment with opioid medicines. Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2026 meeting. CHMP statistics Key figures from the April 2025 CHMP meeting are represented in the graphic below. Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the CHMP plenary session to be held 21-24 July 2025. Note on access to documents The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines. Feb 3, 2026 · EMA publishes the agendas, minutes and highlights of the plenary meetings. Update on compilation of initial Union list of critical medicines by the end 2023 (under HMA EMA Task Force on Availability of Authorised Medicine for Human and Veterinary Use) Discussion on certain national security of supply measures (discussion based on national examples) Joint Action on regulatory flexibilities, including magistral preparations Agenda of the CHMP meeting 27-30 January 2025 Submitted by Anonymous (not verified) on 27 January 2025 - 14:06 Agenda of the CHMP meeting 27-30 January 2025 22 April 2025 - The EMA has published a draft agenda for this week's CHMP meeting. Agenda and minutes The agenda of the September 2024 CHMP meeting is published on EMA's website. Agenda and minutes The agenda of the July 2025 CHMP meeting is published on EMA's website. Explore the activities of EMA's scientific committees and working parties, including pharmacovigilance and risk assessment, ensuring the safety of human medicines. The committee recommended granting a marketing authorisation for Enflonsia (clesrovimab), a medicine indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. The European Medicines Agency (EMA) publishes details of the members and alternates of its Committee for Medicinal Products for Human Use (CHMP). Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Note on access to documents EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting. The committee recommended granting a marketing authorisation for Dawnzera (donidalorsen), for the routine prevention of recurrent attacks of hereditary angioedema (swelling) in adults and adolescents aged 12 years and older. Note on access to documents The document outlines the draft agenda for the CHMP meeting scheduled from January 27 to January 30, 2025, detailing the meeting times and health and safety protocols. A question-and-answer document on the update is available in the grid below. Note on access to documents In a pivotal meeting concluded on July 24, 2025, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) evaluated an array of new drugs for marketing authorization. Discover the activities of scientific committees and working parties in the European Medicines Agency, focusing on medicinal products and their evaluation. *This product was designated as an orphan medicine during its development. Der wissenschaftliche Bewertungsbericht des CHMP bildet 24 February 2025 - The EMA has published a draft agenda for this week's CHMP meeting. Note on access to documents Seventeen new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. Note on access to documents Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. 1 CHMP meeting in August replaced by written procedure 2 3-day meeting due to EMA holidays Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Note on access to documents Agenda and minutes The agenda of the March 2025 CHMP meeting is published on EMA's website. Note on access to documents For more information, see the question-and-answer document in the grid below. Note on access to documents Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Note on access to documents The CHMP is composed of scientists from all member states of the European Economic Area (EEA). Note on access to documents Meeting 13-14 December: Agenda - Minutes Meeting 8-10 November: Agenda - Minutes Meeting 11-13 October: Agenda - Minutes Meeting 13-14 September: Agenda - Minutes Meeting 19-20 July: Agenda - Minutes Meeting 21-22 June: Agenda - Minutes Meeting 17-19 May: Agenda - Minutes Meeting 20-21 April: Agenda - Minutes Meeting 22-23 March: Agenda - Minutes Meeting 22-23 February: Agenda - Minutes The activities outlined in the CHMP work plan for 2025 have been agreed taking into consideration the Agency’s prioritisation set forth in the EMA multi-annual work programme 2024-2026 The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines. An overview of all centrally authorised medicinal products can be found in the Union Register of medicinal products for human use of the European Commission. CHMP members, working party chairs and national experts together with EMA staff are participating in this forum. Note on access to documents CHMP Meeting Highlights Dezember 2025 Der Ausschuss für Humanarzneimittel (CHMP) ist im Rahmen des zentralen Zulassungsverfahrens für neue Arzneimittel für die wissenschaftliche Beurteilung der Antragsunterlagen zur Qualität, Wirksamkeit und Unbedenklichkeit (einschließlich der Umweltverträglichkeit) des Arzneimittels zuständig. The CHMP is due to issue opinions for the following technologies: Immunoglobulin (human) Linvoseltamab Trabectedin Beremagene geperpavec Read CHMP agenda. Other updates The CHMP recommended changes to the existing contraindications of Vfend. EMA also publishes the agendas and minutes of the CHMP's preparatory and organisational matters (PROM) meeting, formerly known as CHMP's organisational matters (ORGAM) meeting. svf6, ajbfv, isimry, 6j9xh0, hbefe4, 4u0da, lyztru, wszq, i6xy, irt3,