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Co je nového

Aktuální aktualizace z EMA — novinky, stanoviska a změny v hodnocení.

EMA: Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004

EMA · Template · 30. 7. 2026

Template - Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004

EMA: Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004

Annex to letter of intent

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2026

Dates of 2027 SAWP meetings and submission deadlines

New leadership team appointments

Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) new safety module

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda

Rxulti (brexpiprazole) Authorised by EMA

Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1 (veterinary)

PecFent (fentanyl) Authorised by EMA

Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Status: Authorised

Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn

EMEA-002883-PIP02-22

Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised

Podcast: Inside EMA

Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1

Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 33, Status: Authorised

Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1

Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

European Medicines Agency’s data protection notice for conducting surveys via EUSurvey

European Medicines Agency’s data protection notice for meeting registration forms via EUSurvey

European Medicines Agency’s data protection notice for conducting surveys via Microsoft Forms

European Medicines Agency’s data protection notice for meeting registration forms via Microsoft Forms

Desloratadine Teva - EMA

Orkambi, lumacaftor, ivacaftor

Cometriq, cabozantinib

Lumykras : EPAR - Risk management plan

Lumykras (sotorasib) authorised by EMA

Kigabeq (vigabatrin) authorised by EMA

Human medicines European public assessment report (EPAR): Padcev, enfortumab vedotin, Date of authorisation: 13/04/2022, Revision: 8, Status: Authorised

Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1

Darzalex (daratumumab) Authorised by EMA

Agenda - PDCO agenda of the 21-24 July 2026 meeting

Takhzyro (lanadelumab) - EMA Authorisation

Ultomiris (ravulizumab) authorised by EMA

Voranigo (vorasidenib) authorised by EMA

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) - EMA Authorisation

Yondelis (trabectedin) - European Medicines Agency

Scemblix (asciminib) authorised by EMA

EMA Authorises Ogsiveo (nirogacestat)

Retacrit (epoetin zeta) - EMA Authorisation

Signal assessment report on neurodevelopmental disorders with paternal exposure to valproate and related substances

Veterinary medicinal products cluster - Terms of reference

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2026

Advice on the influenza virus on request from the Medical Device Coordination Group

Veterinary pharmacovigilance cluster - Terms of reference

Terms of reference for the rare diseases cluster

Terms of reference for the European Medicines Agency – United States Food and Drugs Administration – Health Canada cluster on real world data

Terms of reference for the European Medicines Agency, Health Canada and United States Food and Drugs Administration cluster on vaccines

Human medicines European public assessment report (EPAR): Zemcelpro, allogeneic umbilical cord-derived CD34- cells, non-expanded,dorocubicel, Date of authorisation: 25/08/2025, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Date of authorisation: 18/11/2015, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Date of authorisation: 13/12/2021, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 32, Status: Authorised

Questions and answers: Article 30 referral procedures

Questions and answers on Article 30 referral procedures

Human medicines European public assessment report (EPAR): Maviret, glecaprevir,pibrentasvir, Date of authorisation: 26/07/2017, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Date of authorisation: 14/02/2022, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, Date of authorisation: 31/08/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Paxneury, guanfacine, Date of authorisation: 26/02/2025, Revision: 1, Status: Authorised

EMA/PE/0000241250

EMA/PE/0000182809

Veterinary medicines European public assessment report (EPAR): Poulvac Procerta HVT-ND, Marek’s disease and Newcastle disease vaccine (live recombinant), Status: Authorised

Meeting report of the EMA cancer medicines forum 14 November 2025

Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

EMA/PE/0000235924

Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

Ixchiq

EMA/PE/0000240621

Decision of the Executive Director on rules governing the traineeship programme at the EMA

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

Minutes of the COMP meeting 11-12 May 2026

Human medicines European public assessment report (EPAR): Hetronifly, serplulimab, Date of authorisation: 03/02/2025, Revision: 6, Status: Authorised

PSUSA/00000810/202512

SME info day - navigating EMA support: From development to market authorisation, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 6 November 2026, 09:15 (CET) to 6 November 2026, 16:00 (CET)

Agenda - EnprEMA Coordinating Group meeting, April 2026

Human medicines European public assessment report (EPAR): Fendrix, hepatitis B (rDNA) vaccine (adjuvanted, adsorbed), Date of authorisation: 02/02/2005, Revision: 13, Status: Authorised