What’s new

Find all new and updated information published on our website in one place below. Filters are available to narrow results down based on your interests, such as whether it relates to human or veterinary medicines or specific topics. Information on medicines and related procedures includes a reference to relevant substances: INN or common name, active substance, and English common name for herbal products. This overview covers up to two months back.

As of 1 October 2025, information on medicines and related procedures includes a reference to relevant substances: INN or common name, active substance, and English common name for herbal products.

Results (123)

Date	Content	Status
09/02/2026	Medicine: Datroway datopotamab deruxtecan	Updated
09/02/2026	Medicine: Lytenava bevacizumab	Updated
09/02/2026	Document: Agenda of the PRAC meeting 9-12 February 2026	New
09/02/2026	Page: Plasma master file certificates	Updated
09/02/2026	DHPC: Arixtra - direct healthcare professional communication (DHPC) fondaparinux sodium	New
09/02/2026	Shortage: Tresiba insulin degludec	Updated
09/02/2026	Document: Minutes of the COMP meeting 2-3 December 2025	New
09/02/2026	Document: PhV non-compliance notification contact points at National Competent Authority (NCA) level	Updated
09/02/2026	Medicine: Zypadhera olanzapine	Updated
09/02/2026	Medicine: Azopt brinzolamide	Updated
09/02/2026	Medicine: Xadago safinamide	Updated
09/02/2026	Event: Third European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting	Updated
09/02/2026	Document: PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC meeting	New
09/02/2026	Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC	New
09/02/2026	Document: Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation	New
09/02/2026	Document: List of signals discussed at PRAC since September 2012	Updated
09/02/2026	Medicine: Uptravi selexipag	Updated
06/02/2026	Document: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes	New
06/02/2026	Document: Comments received from public consultation on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women (EMA/653036/2019)	New
06/02/2026	Document: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk	New
06/02/2026	Document: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk	New
06/02/2026	Page: Good pharmacovigilance practices (GVP)	Updated
06/02/2026	Page: Archive of development of good pharmacovigilance practices	Updated
06/02/2026	Page: Fees for veterinary medicines	Updated
06/02/2026	Page: Fees for human medicines	Updated
06/02/2026	Document: Highlights – 1st European Medicine Agency (EMA) and European Respiratory Society (ERS) bilateral meeting	New
06/02/2026	Medicine: Bildyos denosumab	Updated
06/02/2026	Medicine: Tepkinly epcoritamab	Updated
06/02/2026	Medicine: Helicobacter Test INFAI 13C-urea	Updated
06/02/2026	Medicine: Tuznue trastuzumab	Updated
06/02/2026	Medicine: Cibinqo abrocitinib	Updated
06/02/2026	Medicine: Exforge HCT amlodipine besilate; valsartan; hydrochlorothiazide	Updated
06/02/2026	Medicine: Alymsys bevacizumab	Updated
06/02/2026	Medicine: Dafiro HCT amlodipine besilate; valsartan; hydrochlorothiazide	Updated
06/02/2026	Medicine: Copalia HCT amlodipine; valsartan; hydrochlorothiazide	Updated
06/02/2026	Page: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices	Updated
06/02/2026	Page: Combination Products Operational Group: agendas and highlight reports	Updated
06/02/2026	Page: Annual fees payable to the European Medicines Agency	Updated
06/02/2026	Document: Agenda - Combination products operational group, In vitro diagnostics (IVD) stream, 9 February 2026	New
06/02/2026	Medicine: Retsevmo selpercatinib	Updated
06/02/2026	Document: Agenda - Combination products operational group, Medical devices (MD) stream, 12 February 2026	New
06/02/2026	Event: Webinar on the use of platform technologies in the non-clinical and clinical domains	Updated
06/02/2026	Document: Overview of (invented) names reviewed in November 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 11 December 2025	Updated
06/02/2026	Medicine: Rayvow lasmiditan	Updated
06/02/2026	Page: Medicine shortages and availability issues	Updated
06/02/2026	Page: Drug Shortages Global Regulatory Working Group	Updated
06/02/2026	Medicine: Mounjaro tirzepatide	Updated
06/02/2026	PSUSA: PSUSA/00003006/202503 - periodic safety update report single assessment tranexamic acid	New
06/02/2026	Medicine: Insulin aspart Sanofi insulin aspart	Updated
06/02/2026	Medicine: Kisunla donanemab	Updated
06/02/2026	Document: Agenda - Webinar on the use of platform technologies in the non-clinical and clinical domains	Updated
06/02/2026	Medicine: Xerava eravacycline	Updated
06/02/2026	Page: COVID-19 vaccines: key facts	Updated
06/02/2026	Event: LinkedIn Live: How EMA supports innovation in medicine development	New
06/02/2026	Page: Medicines during pregnancy and breastfeeding	Updated
06/02/2026	Medicine: Azarga brinzolamide; timolol	Updated
06/02/2026	Document: Drug Shortages Global Regulatory Working Group: Group statement published on behalf of the Working Group by EMA	New
05/02/2026	Medicine: Eltrombopag Viatris eltrombopag	Updated
05/02/2026	Medicine: Exjade deferasirox	Updated
05/02/2026	Medicine: Dasatinib Accord Healthcare dasatinib	Updated
05/02/2026	Medicine: Kesimpta ofatumumab	Updated
05/02/2026	Medicine: Clopidogrel Zentiva (previously Clopidogrel Winthrop) clopidogrel	Updated
05/02/2026	Medicine: Entyvio vedolizumab	Updated
05/02/2026	Page: PRIME: priority medicines	Updated
05/02/2026	Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 26-29 January 2026	Updated
05/02/2026	Medicine: Vanflyta quizartinib	Updated
05/02/2026	Medicine: Yuvanci macitentan; tadalafil	Updated
05/02/2026	Medicine: Vazkepa icosapent ethyl	Updated
05/02/2026	Medicine: Lyxumia lixisenatide	Updated
05/02/2026	Medicine: Yuflyma adalimumab	Updated
05/02/2026	Event: Committee for Advanced Therapies (CAT): 3-5 December 2025	Updated
05/02/2026	Document: Applications for new human medicines under evaluation: February 2026	New
05/02/2026	Medicine: DuoTrav travoprost; timolol	Updated
05/02/2026	Document: List of medicines currently in PRIME scheme	Updated
05/02/2026	Medicine: Avzivi bevacizumab	Updated
05/02/2026	Medicine: Spevigo spesolimab	Updated
05/02/2026	Document: Procedural advice for vaccine platform technology master file (vPTMF) certification	Updated
05/02/2026	Document: Procedural advice for veterinary vaccine antigen master file (VAMF) certification	Updated
05/02/2026	Medicine: Wegovy semaglutide	Updated
05/02/2026	Medicine: Tocilizumab STADA (previously Tofidence) tocilizumab	Updated
05/02/2026	Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 19-21 January 2026	New
05/02/2026	Document: European Medicines Agency’s data protection notice for EudraVigilance Human (EV)	Updated
05/02/2026	Medicine: Prevenar 13 pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)	Updated
04/02/2026	Event: European Medicines Regulatory Network (EMRN) workshop on Geographic Atrophy endpoints	New
04/02/2026	Document: Start of procedure: Extension of marketing authorisation (12 December 2025 - 29 January 2026)	New
04/02/2026	Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (12 December 2025 - 29 January 2026)	New
04/02/2026	Event: Industry stakeholder webinar on revised environmental risk assessment guideline for medicinal products for human use - 1 year experience	Updated
04/02/2026	Medicine: Kirsty (previously Kixelle) insulin aspart	Updated
04/02/2026	Medicine: Sugammadex Amomed sugammadex	Updated
04/02/2026	Page: Epidemiological data on blood transmissible infections - Scientific guideline	Updated
04/02/2026	Document: Committee for Advanced Therapies (CAT): Work Plan 2026	New
04/02/2026	Page: Interested Parties to the HMPC	Updated
04/02/2026	Document: Hearing the Association of the European Self-Medication Industry (AESGP) during the HMPC November 2025 meeting	New
04/02/2026	Document: PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template	Updated
04/02/2026	Document: Template PRAC assessment report of an non-interventional imposed PASS final study report	Updated
04/02/2026	Medicine: Leqembi lecanemab	Updated
04/02/2026	Page: National competent authorities (human)	Updated
04/02/2026	Medicine: Imraldi adalimumab	Updated
04/02/2026	Medicine: Erleada apalutamide	Updated
04/02/2026	Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)	Updated
04/02/2026	Document: Plasma Master File (PMF) requirements - questions and answers for PMF holders	Updated
03/02/2026	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
03/02/2026	Medicine: Sapropterin Dipharma sapropterin	Updated
03/02/2026	Medicine: Gilenya fingolimod	Updated
03/02/2026	Document: Three-year work plan for the Quality Drafting Group (QDG) of the Committee on Herbal Medicinal Products (HMPC)	Updated
03/02/2026	Document: CHMP work plan 2026	New
03/02/2026	Medicine: Uzpruvo ustekinumab	Updated
03/02/2026	Medicine: Trazimera trastuzumab	Updated
03/02/2026	Medicine: GalliaPharm gallium (68Ga) chloride; germanium (68Ge) chloride	Updated
02/02/2026	Document: Training module EV-M8 - Considerations on the international transfer of personal (health) data in ICSRs -SUSARs originating in the EU	Updated
02/02/2026	Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)	Updated
02/02/2026	Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP)	Updated
02/02/2026	Document: COMP work plan 2026	New
02/02/2026	Page: Qualification of non-mutagenic impurities - Scientific guideline	Updated
02/02/2026	Event: EMA Veterinary Medicines Info Day 2026	Updated
02/02/2026	Document: Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 17 December 2025	New
02/02/2026	Event: 15th industry stakeholder platform on research and development support	Updated
02/02/2026	Document: Recommended submission dates for veterinary medicinal products	Updated
02/02/2026	Event: SPOR and XEVMPD status update webinar - Q1 2026	Updated
02/02/2026	Document: Union Product Database (UPD) registration guide for UI and API users	Updated
02/02/2026	Page: Human Medicines	Updated
02/02/2026	Page: EU enlargement	Updated
02/02/2026	Document: Organisation chart: Human Medicines	Updated

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