icon megaphone to show what's new on website

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. 

Filter by

Categories
Clear

Results (463)

Date Content Status
30/04/2026
Medicine: Scemblix asciminib
Updated
30/04/2026
Medicine: mCombriax influenza mRNA vaccine; COVID-19 mRNA vaccine
Updated
30/04/2026
Event: European Medicines Agency meeting with senior representatives of pharmaceutical companies
 Updated
30/04/2026
Medicine: mResvia Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilised in the prefusion conformation; Respiratory syncytial virus mRNA vaccine (nucleoside modified)
Updated
30/04/2026
Page: Liraglutide 6 mg/mL solution for injection in a prefilled pen product-specific bioequivalence guidance
 New
30/04/2026
Page: Tafamidis soft gelatin capsules 20 mg and 61 mg product-specific bioequivalence guidance
 New
30/04/2026
Event: EMA and European Association of Nuclear Medicine (EANM) bilateral meeting
 Updated
30/04/2026
Document: List of centrally authorised products with safety-related changes to the product information
 Updated
29/04/2026
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC
 Updated
29/04/2026
Page: Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert panel opinions
 Updated
29/04/2026
Document: European Shortages Monitoring Platform (ESMP) User guide for national competent authorities
 Updated
29/04/2026
Page: VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Scientific guideline
 Updated
29/04/2026
Page: ICH Q3C (R9) Residual solvents - Scientific guideline
 Updated
29/04/2026
Document: Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2
 New
29/04/2026
News: EMA launches new advisory group on vaccine confidence
 New
29/04/2026
Page: Advisory group on vaccine confidence
 New
29/04/2026
Document: Vaccine confidence advisory group: Terms of reference
 New
29/04/2026
Page: Website outages and upgrades
 Updated
29/04/2026
Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine
Updated
29/04/2026
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
29/04/2026
Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
 Updated
29/04/2026
Document: List of medicinal products under additional monitoring
 Updated
29/04/2026
Document: List of medicinal products under additional monitoring
 Updated
29/04/2026
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
 Updated
28/04/2026
Medicine: Neuraceq florbetaben (18F)
Updated
28/04/2026
Page: Plasma master file certificates
 Updated
28/04/2026
Document: Agenda - European Platform for Regulatory Science Research meeting
 Updated
28/04/2026
Medicine: Xromi hydroxycarbamide
Updated
28/04/2026
Medicine: Siklos hydroxycarbamide
Updated
28/04/2026
Medicine: Darzalex daratumumab
Updated
28/04/2026
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
 Updated
28/04/2026
Medicine: Micardis telmisartan
Updated
28/04/2026
Medicine: MicardisPlus telmisartan; hydrochlorothiazide
Updated
28/04/2026
MRL: Lidocaine - maximum residue limit lidocaine
Updated
28/04/2026
Document: Records of data processing activity for the use of Microsoft Applications: OneDrive, Outlook 365, Teams and SharePoint
 Updated
28/04/2026
Document: European Medicines Agency’s Data Protection Notice for the use of Microsoft Applications: OneDrive, Outlook 365, Teams and SharePoint
 Updated
28/04/2026
Medicine: Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan) lopinavir; ritonavir
Updated
28/04/2026
Medicine: Tecentriq atezolizumab
Updated
28/04/2026
Medicine: Perjeta pertuzumab
Updated
28/04/2026
Medicine: Dazublys trastuzumab
Updated
28/04/2026
Document: Agenda - European Medicines Regulatory Network workshop on Geographic Atrophy endpoints
 Updated
28/04/2026
Document: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
 Updated
28/04/2026
Medicine: Vfend voriconazole
Updated
28/04/2026
Medicine: Balversa erdafitinib
Updated
28/04/2026
News: New pilot to support development of ‘breakthrough’ medical devices
 New
28/04/2026
Page: Expert panel support for breakthrough medical devices: pilot programme
 Updated
28/04/2026
Document: Advice request: Template for applicants for breakthrough medical devices pilot
 Updated
28/04/2026
Document: Breakthrough status request: Template for applicants for breakthrough medical devices pilot
 Updated
28/04/2026
Document: Highlights - 16th Industry Standing Group meeting
 New
28/04/2026
Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities
 Updated
28/04/2026
Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders
 Updated
28/04/2026
Document: European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders
 Updated
24/04/2026
Shortage: Methotrexate methotrexate
Updated
24/04/2026
Shortage: Hycamtin topotecan
Updated
24/04/2026
Document: Minutes - Executive steering group on shortages and safety of medicinal products (MSSG) - 23 March 2026
 New
24/04/2026
Shortage: Menopur menotropin
Updated
24/04/2026
Shortage: Perfusion solutions
 Updated
24/04/2026
Document: Minutes of the CVMP meeting 10-12 February 2026
 New
24/04/2026
Medicine: Ranluspec ranibizumab
Updated
24/04/2026
Event: 20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP)
 Updated
24/04/2026
Medicine: Besremi ropeginterferon alfa-2b
Updated
24/04/2026
Medicine: Beyfortus nirsevimab
Updated
24/04/2026
Medicine: Epidyolex cannabidiol
Updated
24/04/2026
Document: Orientation guide for patient representatives and healthcare professionals - EMA building
 Updated
24/04/2026
Document: Orientation guide for delegates - EMA building
 Updated
24/04/2026
Medicine: Advate octocog alfa
Updated
24/04/2026
Medicine: Caelyx pegylated liposomal doxorubicin
Updated
24/04/2026
Medicine: Stelara ustekinumab
Updated
24/04/2026
Medicine: Striascan ioflupane (123l)
Updated
24/04/2026
Medicine: Ondibta insulin glargine
Updated
24/04/2026
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
 New
24/04/2026
Medicine: Cenrifki tolebrutinib
New
24/04/2026
Medicine: Palbociclib Viatris palbociclib
New
24/04/2026
Medicine: Itvisma onasemnogene abeparvovec
New
24/04/2026
Medicine: Redemplo plozasiran
New
24/04/2026
Medicine: Rexatilux ranibizumab
New
24/04/2026
Medicine: Viokat diazoxide choline
New
24/04/2026
Post-authorisation: Privigen - opinion on variation to marketing authorisation human normal immunoglobulin (IVIg)
New
24/04/2026
Post-authorisation: Inaqovi - opinion on variation to marketing authorisation cedazuridine; decitabine
New
24/04/2026
Post-authorisation: Opdivo - opinion on variation to marketing authorisation nivolumab
New
24/04/2026
Post-authorisation: Aquipta - opinion on variation to marketing authorisation atogepant
New
24/04/2026
Post-authorisation: Crysvita - opinion on variation to marketing authorisation burosumab
New
24/04/2026
Post-authorisation: Skyrizi - opinion on variation to marketing authorisation risankizumab
New
24/04/2026
Post-authorisation: Comirnaty - opinion on variation to marketing authorisation COVID-19 mRNA vaccine
New
24/04/2026
Post-authorisation: Venclyxto - opinion on variation to marketing authorisation venetoclax
New
24/04/2026
Post-authorisation: Venclyxto - opinion on variation to marketing authorisation venetoclax
New
24/04/2026
Document: Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products
 New
24/04/2026
Page: Demonstration of biosimilarity of biological veterinary medicinal products - Scientific guideline
 New
24/04/2026
Event: ACT EU webinar on contractual agreements
Updated
24/04/2026
Event: EnprEMA & ACT EU workshop on paediatric clinical trials
 Updated
24/04/2026
Orphan: EU/3/17/1941 - orphan designation for treatment of Prader-Willi syndrome diazoxide choline
Updated
24/04/2026
Event: Clinical Trials Information System (CTIS): Walk-in clinic April 2026
 Updated
24/04/2026
Event: European Platform for Regulatory Science Research meeting
 Updated
24/04/2026
Event: CVMP Interested Parties’ meeting 2026
 New
24/04/2026
Post-authorisation: Pluvicto - withdrawal of application for variation to marketing authorisation lutetium (177Lu) vipivotide tetraxetan
New
24/04/2026
Document: Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1
 New
24/04/2026
Page: Use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union - Scientific guideline
 Updated
24/04/2026
Medicine: Vysribli (previously Denosumab Intas) Vysribli
Updated
24/04/2026
Orphan: EU/3/21/2459 - orphan designation for treatment of familial chylomicronaemia syndrome synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues
Updated
24/04/2026
News: New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome
 New
23/04/2026
PIP: EMEA-001776-PIP01-15-M01 - paediatric investigation plan risankizumab
Updated
23/04/2026
Medicine: Terrosa teriparatide
Updated
23/04/2026
Medicine: Kinpeygo budesonide
Updated
23/04/2026
Medicine: Jayempi azathioprine
Updated
23/04/2026
Medicine: Aptivus tipranavir
Updated
23/04/2026
Medicine: Praxbind idarucizumab
Updated
23/04/2026
Medicine: Jemperli dostarlimab
Updated
23/04/2026
Medicine: Zilbrysq zilucoplan
Updated
23/04/2026
DHPC: Savene - direct healthcare professional communication (DHPC) dexrazoxane
New
23/04/2026
Medicine: Opsumit macitentan
Updated
23/04/2026
Medicine: Nulojix belatacept
Updated
23/04/2026
Medicine: Taltz ixekizumab
Updated
23/04/2026
Medicine: Remsima infliximab
Updated
23/04/2026
Medicine: Amgevita adalimumab
Updated
23/04/2026
News: EMA business hours over King's Day and Labour Day, 27 April and 1 May
 New
23/04/2026
Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)
 Updated
23/04/2026
Page: Podcast: Inside EMA
 Updated
23/04/2026
Page: Referentials Management Service (RMS)
 Updated
22/04/2026
Medicine: Movymia teriparatide
Updated
22/04/2026
Orphan: EU/3/26/3225 - orphan designation for prevention of corneal graft rejection aganirsen
New
22/04/2026
Orphan: EU/3/26/3224 - orphan designation for treatment of large B-cell lymphoma surovatamig
New
22/04/2026
Orphan: EU/3/26/3222 - orphan designation for treatment of myelofibrosis 3-(4-((7-Cyano-1-methyl-2-((1-methyl-2-oxo-5-(trifluoromethyl)-1,2-dihydropyridin-3-yl)amino)-1H-imidazo[4,5-b]pyridin-6-yl)oxy)pyridin-2-yl)-1,1-dimethylurea
New
22/04/2026
Orphan: EU/3/26/3226 - orphan designation for treatment of Duchenne muscular dystrophy adeno-associated virus serotype SLB101 containing the human microdystrophin gene
New
22/04/2026
Orphan: EU/3/26/3229 - orphan designation for treatment of SYNGAP1-related disorder antisense oligonucleotide against SYNGAP1 regulatory RNA
New
22/04/2026
Medicine: Vyndaqel tafamidis
Updated
22/04/2026
Orphan: EU/3/26/3220 - orphan designation for treatment of systemic sclerosis upadacitinib
New
22/04/2026
Orphan: EU/3/26/3228 - orphan designation for treatment of congenital factor V deficiency coagulation factor V
New
22/04/2026
Page: Procurement and grants
 Updated
22/04/2026
Orphan: EU/3/26/3223 - orphan designation for treatment of VEXAS syndrome Momelotinib dihydrochloride monohydrate
New
22/04/2026
Orphan: EU/3/26/3227 - orphan designation for treatment of pancreatic cancer daraxonrasib
New
22/04/2026
Medicine: Volibris ambrisentan
Updated
22/04/2026
Orphan: EU/3/26/3221 - orphan designation for treatment of spinal cord injury oremepermin alfa
New
22/04/2026
Orphan: EU/3/26/3218 - orphan designation for treatment of myelodysplastic syndromes lisaftoclax
New
22/04/2026
Orphan: EU/3/26/3214 - orphan designation for treatment of CACNA1A disorders acetylleucine
New
22/04/2026
Medicine: Dabigatran Etexilate Accord dabigatran etexilate
Updated
22/04/2026
Orphan: EU/3/26/3216 - orphan designation for treatment of Alport syndrome exaluren sulfate
New
22/04/2026
Orphan: EU/3/26/3210 - orphan designation for treatment of vernal keratoconjunctivitis tacrolimus monohydrate
New
22/04/2026
Medicine: Forxiga dapagliflozin
Updated
22/04/2026
Medicine: Erleada apalutamide
Updated
22/04/2026
Medicine: Ozempic semaglutide
Updated
22/04/2026
Medicine: Rybelsus semaglutide
Updated
22/04/2026
Medicine: Noxafil posaconazole
Updated
22/04/2026
Medicine: Loqtorzi toripalimab
Updated
22/04/2026
Medicine: Rotarix rotavirus vaccine, live
Updated
22/04/2026
Medicine: Irbesartan Zentiva (previously Irbesartan Winthrop) irbesartan
Updated
22/04/2026
Medicine: Keytruda pembrolizumab
Updated
22/04/2026
Medicine: Enflonsia clesrovimab
Updated
22/04/2026
Orphan: EU/3/26/3215 - orphan designation for treatment of pulmonary neuroendocrine carcinoma atigotatug; nivolumab
New
22/04/2026
Orphan: EU/3/26/3217 - orphan designation for treatment of hepatocellular carcinoma irpagratinib tosilate monohydrate
New
22/04/2026
Orphan: EU/3/26/3213 - orphan designation for treatment of pancreatic cancer telisotuzumab adizutecan
New
22/04/2026
Orphan: EU/3/26/3211 - orphan designation for treatment of homocystinuria and/or methylmalonic acidaemia due to genetic defects of intracellular cobalamin processing hydroxocobalamin acetate
New
22/04/2026
Orphan: EU/3/26/3209 - orphan designation for treatment of pulmonary neuroendocrine carcinoma humanised IgG1 monoclonal antibody against SEZ6, conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide
New
21/04/2026
Medicine: Pyrukynd mitapivat
Updated
21/04/2026
Medicine: Verquvo vericiguat
Updated
21/04/2026
Document: Clinical Data Publication (CDP) - Questions and Answers (Q&As) on the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC)
 New
21/04/2026
Medicine: Veoza fezolinetant
Updated
21/04/2026
Document: Agenda - PDCO agenda of the 21-24 April 2026 meeting
 New
21/04/2026
Medicine: Ezmekly mirdametinib
Updated
21/04/2026
Medicine: Arsenic trioxide medac arsenic trioxide
Updated
21/04/2026
Herbal: Centaurii herba - herbal medicinal product Centaury
Updated
21/04/2026
Medicine: Evrysdi risdiplam
Updated
21/04/2026
Medicine: Orphacol cholic acid
Updated
21/04/2026
Medicine: Ferriprox deferiprone
Updated
21/04/2026
Document: Process for the electronic submission of medicinal product information - Chapter 3
 Updated
21/04/2026
Document: Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas - Chapter 9
 Updated
21/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - March 2026
 Updated
21/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026
 Updated
21/04/2026
Shortage: Moventig
 Updated
21/04/2026
Document: Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)
 Updated
20/04/2026
Document: Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD)
 Updated
20/04/2026
Orphan: EU/3/26/3212 - orphan designation for treatment of large granular lymphocytic leukaemia dibotatug
New
20/04/2026
Event: Committee for Medicinal Products for Human Use (CHMP): 20-23 April 2026
 Updated
20/04/2026
Document: Annex to agenda of the CHMP meeting 20-23 April 2026
 New
20/04/2026
Document: Agenda of the CHMP meeting 20-23 April 2026
 New
20/04/2026
Orphan: EU/3/26/3219 - orphan designation for treatment of Behçet's Disease dusquetide
New
20/04/2026
Medicine: Roteas edoxaban
Updated
20/04/2026
Medicine: Lixiana edoxaban
Updated
20/04/2026
Event: European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry
 Updated
20/04/2026
Medicine: Aclasta zoledronic acid
Updated
20/04/2026
Page: Submission dates
 Updated
20/04/2026
Page: Respiratory syncytial virus (RSV)
 New
20/04/2026
Medicine: Dupixent dupilumab
Updated
20/04/2026
Document: Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
 Updated
20/04/2026
Document: Focus group on submission predictability: 2025 final report
 New
17/04/2026
Herbal: Rusci rhizoma - herbal medicinal product Butcher's Broom
Updated
17/04/2026
Medicine: Tepmetko tepotinib
Updated
17/04/2026
Post-authorisation: Startvac - opinion on variation to marketing authorisation adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci
New
17/04/2026
Medicine: Nobivac NXT HCPChFeLV feline calicivirosis, feline rhinotracheitis, feline panleucopenia, feline chlamydiosis (live) and feline leukemia (RNA replicon particle) vaccine
New
17/04/2026
News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026
 New
17/04/2026
News: EMA recommends authorisation of first veterinary vaccine using RNA technology
 New
17/04/2026
Medicine: Rezurock belumosudil
Updated
17/04/2026
Medicine: Teizeild teplizumab
Updated
17/04/2026
Medicine: Livmarli maralixibat chloride
Updated
16/04/2026
Medicine: Atriance nelarabine
Updated
16/04/2026
Medicine: Steqeyma ustekinumab
Updated
16/04/2026
Page: Recommendations on medication errors
 Updated
16/04/2026
Document: Minutes - HMA-EMA joint Network Data Steering Group meeting - 9 March 2026
 New
16/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - October 2026
 New
16/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - July 2026
 New
16/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - June 2026
 New
16/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - November 2026
 New
16/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - December 2026
 New
16/04/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - September 2026
 New
16/04/2026
Page: Human papillomavirus (HPV)
 Updated
16/04/2026
Page: Applying for orphan designation
 Updated
16/04/2026
Medicine: Qoyvolma ustekinumab
Updated
16/04/2026
Document: Procedural advice for orphan medicinal product designation: Guidance for sponsors
 Updated
16/04/2026
Event: ACT EU webinar on draft guidance on the conduct of clinical trials during public health emergencies
 Updated
16/04/2026
Document: Regulatory Procedure Management in IRIS roadmap
 Updated
16/04/2026
Document: Chapter 3.II: XEVPRM detailed user guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
 Updated
16/04/2026
Medicine: Zolsketil pegylated liposomal doxorubicin
Updated
16/04/2026
DHPC: Levamisole - direct healthcare professional communication (DHPC) levamisole
New
16/04/2026
Medicine: Emtricitabine / Tenofovir alafenamide Viatris emtricitabine; tenofovir alafenamide
Updated
16/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - September 2026
 New
16/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - November 2026
 New
16/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - December 2026
 New
16/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - October 2026
 New
16/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - July 2026
 New
16/04/2026
Event: Q&A clinic on Substance, Organisation, Referentials Management Services - June 2026
 New
16/04/2026
Event: Webinar on reflection paper on the qualification of non-mutagenic impurities
 New
16/04/2026
Page: CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device
 Updated
16/04/2026
Document: IVF Media G5 - Procedural steps and scientific information after initial consultation
 Updated
16/04/2026
PSUSA: PSUSA/00002475/202509 - periodic safety update report single assessment povidone, polyvinyl alcohol / povidone
New
16/04/2026
Medicine: Ocrevus ocrelizumab
Updated
16/04/2026
Medicine: Icatibant Accord icatibant
Updated
16/04/2026
Medicine: Myqorzo aficamten
Updated
16/04/2026
Medicine: Enwylma denosumab
Updated
16/04/2026
Document: Procedural advice on paediatric applications
 Updated
16/04/2026
Document: Template for scientific document for paediatric investigation plan or product-specific waiver
 Updated
16/04/2026
Document: Paediatric investigation plan (PIP) - Key elements form
 Updated
15/04/2026
PSUSA: PSUSA/00001392/202508 - periodic safety update report single assessment finasteride
New
15/04/2026
EU-M4all: Acoziborole Winthrop - opinion on medicine for use outside EU acoziborole
Updated
15/04/2026
Medicine: Jelrix autologous cartilage-derived articular chondrocytes, in-vitro expanded
Updated
15/04/2026
Medicine: Kygevvi doxecitine; doxribtimine
Updated
15/04/2026
Medicine: Teduglutide Viatris teduglutide
Updated
15/04/2026
Medicine: Prialt ziconotide
Updated
15/04/2026
Page: EU Innovation Network (EU-IN)
 Updated
15/04/2026
Document: Radiopharmaceuticals EU-IN Horizon Scanning Report
 New
15/04/2026
PSUSA: PSUSA/00000073/202507 - periodic safety update report single assessment albendazole
New
15/04/2026
Medicine: Lorviqua lorlatinib
Updated
15/04/2026
Medicine: Jorveza budesonide
Updated
15/04/2026
Medicine: Bortezomib Hospira bortezomib
Updated
15/04/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
14/04/2026
Orphan: EU/3/25/3140 - orphan designation for treatment of pulmonary neuroendocrine carcinoma risvutatug rezetecan
New
14/04/2026
Orphan: EU/3/25/3144 - orphan designation for treatment of Rett syndrome fenfluramine hydrochloride
New
14/04/2026
Page: Paediatric investigation plans: questions and answers
 Updated
14/04/2026
Orphan: EU/3/25/3141 - orphan designation for treatment of Hirschsprung's disease glial cell line-derived neurotrophic factor; sodium butyrate
New
14/04/2026
Orphan: EU/3/25/3137 - orphan designation for treatment of amyotrophic lateral sclerosis Unasnemab
New
14/04/2026
PSUSA: PSUSA/00001912/202509 - periodic safety update report single assessment losartan
New
14/04/2026
Orphan: EU/3/25/3138 - orphan designation for treatment of Glanzmann thrombasthenia sutacimig
New
14/04/2026
Orphan: EU/3/25/3142 - orphan designation for treatment of primary IgA nephropathy mezagitamab
New
14/04/2026
Orphan: EU/3/25/3136 - orphan designation for treatment of Glanzmann thrombasthenia ozisiran
New
14/04/2026
Orphan: EU/3/25/3143 - orphan designation for treatment of congenital aceruloplasminemia ceruloplasmin
New
14/04/2026
Document: List of industry subject matter experts and list of planned calls for industry subject matter experts
 Updated
14/04/2026
Orphan: EU/3/25/3156 - orphan designation for treatment of primary membranous nephropathy Felzartamab
New
14/04/2026
Orphan: EU/3/25/3158 - orphan designation for treatment of systemic sclerosis resecabtagene autoleucel
New
14/04/2026
Orphan: EU/3/25/3147 - orphan designation for treatment of sickle cell disease nangibotide
New
14/04/2026
Orphan: EU/3/25/3139 - orphan designation for treatment of Huntington's disease bevantolol hydrochloride
New
14/04/2026
Orphan: EU/3/25/3157 - orphan designation for treatment of hypochondroplasia Infigratinib
New
14/04/2026
Orphan: EU/3/25/3145 - orphan designation for treatment of peripheral T-cell lymphoma soquelitinib
New
14/04/2026
Orphan: EU/3/26/3207 - orphan designation for treatment of inherited retinal dystrophy due to biallelic autosomal recessive mutations in the human guanylate cyclase 1 (GUCY2D) gene non-replicating adeno-associated virus serotype 5 containing the human retinal guanylate cyclase 1 gene
New
14/04/2026
Orphan: EU/3/26/3198 - orphan designation for treatment of intestinal failure-associated liver disease orziloben
New
14/04/2026
Orphan: EU/3/26/3200 - orphan designation for treatment of acute respiratory distress syndrome (ARDS) aviptadil
New
14/04/2026
Shortage: Creon pancreas powder; pancrelipase
Updated
14/04/2026
Orphan: EU/3/26/3202 - orphan designation for treatment of palmoplantar pustulosis 1-{[2-(3,6-Diazabicyclo[3.1.1]heptan-3-yl)-7-(1,3-thiazol-2-yl)-1,3-benzoxazol-4-yl]oxy}-1,1-difluoro-2-methylpropan-2-ol
New
14/04/2026
PSUSA: PSUSA/00000415/202508 - periodic safety update report single assessment biperiden
New
14/04/2026
PSUSA: PSUSA/00000813/202508 - periodic safety update report single assessment clonidine
New
14/04/2026
Medicine: Bluevac BTV (previously Bluevac BTV8)
 Updated
14/04/2026
Medicine: Spevigo spesolimab
Updated
14/04/2026
Medicine: Pavblu aflibercept
Updated
14/04/2026
Orphan: EU/3/26/3206 - orphan designation for treatment of ovarian cancer rinatabart sesutecan
New
14/04/2026
Orphan: EU/3/26/3208 - orphan designation for treatment of inherited retinal dystrophy due to dysfunction in the human retinoschisin (RS1) gene adeno-associated viral vector serotype 44.9 containing the human HRS1 gene
New
14/04/2026
Orphan: EU/3/26/3195 - orphan designation for treatment of primary IgA nephropathy sefaxersen
New
14/04/2026
Document: Article 57 product data
 Updated
14/04/2026
Document: Applications for new human medicines under evaluation: April 2026
 New
14/04/2026
Event: Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 April 2026
 Updated
13/04/2026
PSUSA: PSUSA/00002156/202508 - periodic safety update report single assessment nifedipine
New
13/04/2026
PSUSA: PSUSA/00001945/202508 - periodic safety update report single assessment meclozine
New
13/04/2026
PSUSA: PSUSA/00010224/202508 - periodic safety update report single assessment fluocinolone acetonide (intravitreal implant in applicator)
New
13/04/2026
Medicine: Aripiprazole Sandoz aripiprazole
Updated
13/04/2026
PSUSA: PSUSA/00002605/202509 - periodic safety update report single assessment raltitrexed
New
13/04/2026
Orphan: EU/3/26/3205 - orphan designation for treatment of primary membranous nephropathy povetacicept
New
13/04/2026
Document: Records of data processing activity for the EudraVigilance Signal and Safety Analytics (EV SSA) platform
New
13/04/2026
Document: PDCO minutes of the 24-27 February 2026 meeting
 New
10/04/2026
Orphan: EU/3/25/3186 - orphan designation for treatment of primary IgA nephropathy N-[5-(2H-1,3-Benzodioxol-5-yl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-N'-(2-methoxyethyl)sulfuric diamide
New
10/04/2026
Orphan: EU/3/25/3187 - orphan designation for treatment of multiple system atrophy 2-[[(4-Methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazol-5-ol
New
10/04/2026
Orphan: EU/3/25/3180 - orphan designation for diagnosis of ovarian cancer aminolevulinic acid hydrochloride
New
10/04/2026
Orphan: EU/3/25/3179 - orphan designation for treatment of primary hyperoxaluria lanthanum carbonate octahydrate
New
10/04/2026
Orphan: EU/3/25/3189 - orphan designation for treatment of osteosarcoma sirolimus
New
10/04/2026
PIP: EMEA-001811-PIP03-20 - paediatric investigation plan ligelizumab
Updated
10/04/2026
Medicine: Mysimba naltrexone; bupropion
Updated
10/04/2026
Orphan: EU/3/25/3191 - orphan designation for treatment of BAG3 dilated cardiomyopathy Adeno-associated virus serotype ATC-0187 vector containing the human BAG3 gene
New
10/04/2026
Orphan: EU/3/25/3190 - orphan designation for treatment of osteosarcoma domatinostat
New
10/04/2026
Orphan: EU/3/25/3181 - orphan designation for treatment of Fanconi anaemia autologous human T cells transduced with a lentiviral vector encoding a chimeric antigen receptor against the ERBB family
New
10/04/2026
Orphan: EU/3/25/3193 - orphan designation for treatment of central serous chorioretinopathy spironolactone
New
10/04/2026
Medicine: Equidormin midazolam
New
10/04/2026
Orphan: EU/3/25/3188 - orphan designation for treatment of idiopathic pulmonary fibrosis Phe-Thr-Thr-Phe-Thr-Val-Thr
New
10/04/2026
Orphan: EU/3/25/3192 - orphan designation for treatment of extrapulmonary neuroendocrine carcinoma opamtistomig
New
10/04/2026
Medicine: Evrenzo roxadustat
Updated
10/04/2026
Orphan: EU/3/26/3197 - orphan designation for treatment of spinal cord injury (4Z,7R,8E,10E,12Z,14S,16Z,19Z)-7,14-Dihydroxydocosa-4,8,10,12,16,19-hexaenoic acid
New
10/04/2026
Medicine: Mycophenolate mofetil Teva mycophenolate mofetil
Updated
10/04/2026
Orphan: EU/3/26/3203 - orphan designation for treatment of limbal stem cell deficiency spironolactone
New
10/04/2026
Medicine: Olumiant baricitinib
Updated
10/04/2026
Orphan: EU/3/26/3201 - orphan designation for treatment of mesothelioma Measles virus Schwarz strain (live, attenuated)
New
10/04/2026
Orphan: EU/3/26/3196 - orphan designation for treatment of glioma Humanised IgG1 kappa monoclonal antibody against erythropoietin isoform EV-3
New
10/04/2026
Orphan: EU/3/26/3204 - orphan designation for treatment of erythromelalgia N-[(1S)-1-(4-Tert-butylphenyl) ethyl]-2-(6,7-difluoro-1H-benzimidazol-1-yl)acetamide
New
10/04/2026
Orphan: EU/3/25/3146 - orphan designation for treatment of Glb1-related disorders autologous peripheral blood-derived CD34+ haematopoietic stem and progenitor cells transduced with a lentiviral vector containing the murine Glb1 gene
New
10/04/2026
Orphan: EU/3/25/3149 - orphan designation for treatment of KCNT1-related epilepsy and neurodevelopmental disorders (S)-1-(2,2-Difluoroethyl)-3-(difluoromethyl)-N-(1-(3-(2-methoxypyridin-4-yl)-1,2,4-oxadiazol-5-yl)ethyl)-1H-pyrazole-5-carboxamide
New
10/04/2026
Orphan: EU/3/25/3153 - orphan designation for treatment of pancreatic cancer vopimetostat
New
10/04/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
 New
10/04/2026
Medicine: Myfenax mycophenolate mofetil
Updated
10/04/2026
PIP: EMEA-003268-PIP01-22 - paediatric investigation plan 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3- fluorophenyl)ethan-1-one (BBP-671)
Updated
10/04/2026
PSUSA: PSUSA/00003170/202508 - periodic safety update report single assessment hexoprenaline sulfate
New
10/04/2026
Orphan: EU/3/25/3103 - orphan designation for treatment of idiopathic pulmonary fibrosis admilparant
New
10/04/2026
Orphan: EU/3/25/3107 - orphan designation for treatment of congenital athymia allogeneic cultured postnatal thymus-derived tissue
New
10/04/2026
Orphan: EU/3/25/3104 - orphan designation for treatment of acute myeloid leukaemia 4-(2-{[2-Amino-6-(3-chloro-2-methylphenyl)pyrimidin-4-yl]amino}ethyl)benzene-1-sulfonamide
New
10/04/2026
Orphan: EU/3/25/3115 - orphan designation for treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene gildeuretinol, gildeuretinol acetate
New
10/04/2026
Orphan: EU/3/25/3114 - orphan designation for treatment of alpha-1 antitrypsin deficiency RNA editing antisense oligonucleotide against the Z mutation of the human SERPINA1 mRNA transcript, sodium salt
New
10/04/2026
Orphan: EU/3/25/3133 - orphan designation for treatment of NDP gene-related disorders adeno-associated viral vector serotype ShH10 containing a codon-optimised human NDP gene
New
10/04/2026
Orphan: EU/3/25/3106 - orphan designation for treatment of multiple myeloma IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D
New
10/04/2026
Orphan: EU/3/25/3129 - orphan designation for treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3122 - orphan designation for treatment of uveal melanoma darovasertib
New
10/04/2026
Orphan: EU/3/25/3113 - orphan designation for treatment of hereditary cerebral amyloid angiopathies acetylcysteine amide
New
10/04/2026
Orphan: EU/3/25/3110 - orphan designation for treatment of spinal muscular atrophy emugrobart
New
10/04/2026
Orphan: EU/3/25/3105 - orphan designation for treatment of dystrophic myotonia RNA, [P-deoxy-P-(dimethylamino)](2',3'-dideoxy-2',3'-imino-2',3'-seco)(2'a->5') (C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-G-C-A-[2'a-[39-[[1-acetyl-L-prolyl-L-lysyl-L-lysyl-L-lysyl-L-arginyl-L-lysyl-L-valyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-(L-phenylalanylglycyl-L-phenylalanylglycyl-L-arginylglycyl-L-arginyl-L-gamma-glutamyl)-L-lysyl]amino]-1- oxo-4,7,10,13,16,19,22,25,28,31,34,37-dodecaoxanonatriacont-1-yl]]G), (8'->1')-lactam
New
10/04/2026
Orphan: EU/3/25/3120 - orphan designation for treatment of immunoglobulin G4-related disease rilzabrutinib
New
10/04/2026
Orphan: EU/3/25/3109 - orphan designation for treatment of NDP gene-related disorders adeno-associated virus serotype 9 vector containing the human NDP gene
New
10/04/2026
Orphan: EU/3/25/3124 - orphan designation for treatment of immune thrombocytopenia mezagitamab
New
10/04/2026
Orphan: EU/3/25/3128 - orphan designation for treatment of pancreatic cancer 7-ethyl-10-hydroxycamptothecin
New
10/04/2026
Orphan: EU/3/25/3111 - orphan designation for treatment of graft-versus-host disease pegtarazimod
New
10/04/2026
Orphan: EU/3/25/3102 - orphan designation for prevention of bronchopulmonary dysplasia mecasermin rinfabate
New
10/04/2026
Orphan: EU/3/25/3112 - orphan designation for treatment of methylmalonic acidaemia lentiviral vector containing the human MMUT transgene
New
10/04/2026
Orphan: EU/3/25/3152 - orphan designation for treatment of MECP2 duplication syndrome 2'-O-(2-Methoxyethyl) modified antisense oligonucleotide against MECP2 pre-mRNA
New
10/04/2026
Orphan: EU/3/25/3123 - orphan designation for treatment of common variable immunodeficiency (CVID) leniolisib
New
10/04/2026
Orphan: EU/3/25/3108 - orphan designation for treatment of acute myeloid leukaemia cladribine
New
10/04/2026
Orphan: EU/3/25/3148 - orphan designation for treatment of amyotrophic lateral sclerosis 2-(3-Chlorophenyl)-N-[6-(trifluoromethyl)-1,3-benzothiazol-2-yl]acetamide
New
10/04/2026
Orphan: EU/3/25/3118 - orphan designation for treatment of primary hyperoxaluria mRNA encoding Cas12HF endonuclease, Single guide RNA against the human HAO1 gene
New
10/04/2026
Orphan: EU/3/25/3117 - orphan designation for treatment of lymphoplasmacytic lymphoma 3-tert-butyl-N-{(1R)-1-[4-(6-{6-[4-({1-[4-(2,4-dioxo-1,3-diazinan-1-yl)phenyl]piperidin-4-yl}methyl)piperazin-1-yl]pyridin-3-yl}-7H-pyrrolo[2,3-d]pyrimidin-4-yl)-2-methylphenyl]ethyl}-1,2,4-oxadiazole-5-carboxamide
New
10/04/2026
Orphan: EU/3/25/3134 - orphan designation for treatment of non-syndromic macular dystrophy sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3121 - orphan designation for treatment of idiopathic inflammatory myopathy brepocitinib
New
10/04/2026
Orphan: EU/3/25/3154 - orphan designation for treatment of non-syndromic inherited retinal dystrophies due to defects in the ABCA4 gene antisense oligonucleotide against ABCA4 pre-mRNA
New
10/04/2026
Orphan: EU/3/25/3155 - orphan designation for treatment of oesophageal cancer zanidatamab
New
10/04/2026
Orphan: EU/3/25/3125 - orphan designation for treatment of glioma temozolomide
New
10/04/2026
Orphan: EU/3/25/3127 - orphan designation for treatment of soft tissue sarcoma varegacestat
New
10/04/2026
Orphan: EU/3/25/3119 - orphan designation for treatment of fibrodysplasia ossificans progressiva zilurgisertib
New
10/04/2026
Orphan: EU/3/25/3130 - orphan designation for treatment of syndromic inherited retinal dystrophies of the cone-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3131 - orphan designation for treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
Orphan: EU/3/25/3135 - orphan designation for treatment of primary large B-cell lymphoma of immune-privileged sites methotrexate
New
10/04/2026
Orphan: EU/3/25/3132 - orphan designation for treatment of non-syndromic inherited retinal dystrophies of the cone-dominant phenotype sonpiretigene isteparvovec
New
10/04/2026
PIP: EMEA-003071-PIP02-23 - paediatric investigation plan cedazuridine; decitabine
Updated
10/04/2026
Medicine: Mynzepli aflibercept
Updated
10/04/2026
Orphan: EU/3/25/3151 - orphan designation for treatment of primary sclerosing cholangitis leuconostoc citreum, strain G511, Live
New
10/04/2026
Medicine: Myclausen mycophenolate mofetil
Updated
10/04/2026
Orphan: EU/3/25/3159 - orphan designation for treatment of idiopathic pulmonary fibrosis orvepitant maleate
New
10/04/2026
Medicine: Abrysvo respiratory syncytial virus vaccine (bivalent, recombinant)
Updated
10/04/2026
Medicine: CellCept mycophenolate mofetil
Updated
10/04/2026
Page: Download medicine data
 Updated
10/04/2026
Page: Download website data in JSON data format
 Updated
09/04/2026
Medicine: Cablivi caplacizumab
Updated
09/04/2026
Medicine: Tafinlar dabrafenib
Updated
09/04/2026
Medicine: Iclusig ponatinib
Updated
09/04/2026
Medicine: Sorafenib Accord sorafenib
Updated
09/04/2026
Medicine: Kayshild semaglutide
Updated
09/04/2026
Medicine: Fylrevy estetrol
Updated
09/04/2026
Page: Union Product Database
 Updated
09/04/2026
Medicine: Fintepla fenfluramine
Updated
09/04/2026
Medicine: Neofordex dexamethasone
Updated
09/04/2026
Medicine: Copiktra duvelisib
Updated
09/04/2026
Page: Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline
 Updated
09/04/2026
Page: Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline
 Updated
09/04/2026
Document: Template for sharing EMA documents by Industry to support reliance
 Updated
09/04/2026
Document: Clinical Trial Information System (CTIS) - Sponsor Frequently Asked Questions (FAQ)
 Updated
09/04/2026
Medicine: Theralugand lutetium (177Lu) chloride
Updated
09/04/2026
Page: PRIME: priority medicines
 Updated
09/04/2026
Medicine: Sibnayal potassium citrate; potassium hydrogen carbonate
Updated
09/04/2026
Document: List of medicines currently in PRIME scheme
 Updated
09/04/2026
Document: List of eligible industry stakeholder organisations
 Updated
08/04/2026
Page: Vaccines: concerns, questions and false claims
 Updated
08/04/2026
Page: COVID-19 vaccines: key facts
 Updated
08/04/2026
Medicine: Supemtek trivalent influenza vaccine (recombinant, prepared in cell culture)
Updated
08/04/2026
Medicine: Blenrep belantamab mafodotin
Updated
08/04/2026
Medicine: Yellox bromfenac
Updated
08/04/2026
Medicine: Fycompa perampanel
Updated
08/04/2026
Medicine: Agamree vamorolone
Updated
08/04/2026
Medicine: Rebif interferon beta-1a
Updated
08/04/2026
Medicine: Aripiprazole Zentiva aripiprazole
Updated
08/04/2026
Medicine: Poteligeo mogamulizumab
Updated
08/04/2026
Event: Breakthrough medical devices: information session
 Updated
08/04/2026
Medicine: Crysvita burosumab
Updated
08/04/2026
Medicine: Rezzayo rezafungin
Updated
08/04/2026
Medicine: Doptelet avatrombopag
Updated
08/04/2026
Referral: Levamisole-containing medicinal products - referral levamisole
Updated
08/04/2026
Page: Maximum residue limits (MRLs): Questions and answers
 New
08/04/2026
Page: Substances exempt from maximum residue limit evaluation
 New
08/04/2026
Page: Submitting a maximum residue limit application
 New
08/04/2026
Page: Establishing maximum residue limits for veterinary medicines
 New
08/04/2026
Page: Maximum residue limits (MRL)
 Updated
08/04/2026
Page: Animal health practitioners
 Updated
08/04/2026
Page: Veterinary medicine safety day
 New
08/04/2026
Document: Veterinary medicine safety day 2026: Image carousel
 New
08/04/2026
Document: Veterinary medicine safety day 2026: Campaign poster
 New
08/04/2026
Document: Veterinary medicine safety day: How to check veterinary medicines are working
 New
08/04/2026
Document: Veterinary medicine safety day 2026: Expert presentation
 New
08/04/2026
Document: Veterinary medicine safety day: Why read veterinary medicines package leaflet
 New
08/04/2026
Document: Veterinary medicine safety day: How to dispose of unused veterinary medicines
 New
08/04/2026
Document: CHMP PROM minutes for the meeting on 6 October 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 8 September 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 14 July 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 10 June 2025
 Updated
08/04/2026
Document: CHMP PROM minutes for the meeting on 12 May 2025
 Updated
07/04/2026
Medicine: Viramune nevirapine
Updated
07/04/2026
PSUSA: PSUSA/00002042/202507 - periodic safety update report single assessment metronidazole / miconazole, chlorquinaldol / metronidazole
Updated
07/04/2026
PSUSA: PSUSA/00002661/202507 - periodic safety update report single assessment ropinirole
New
07/04/2026
Medicine: Imcivree setmelanotide
Updated
07/04/2026
Medicine: Neupro rotigotine
Updated
07/04/2026
Medicine: Kavigale sipavibart
Updated
07/04/2026
Medicine: Aerinaze desloratadine; pseudoephedrine
Updated
07/04/2026
Document: Public engagement highlights 2025
 New
07/04/2026
Medicine: Zokinvy lonafarnib
Updated
07/04/2026
Event: Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2026
 Updated
07/04/2026
Medicine: Opdualag relatlimab; nivolumab
Updated
07/04/2026
Medicine: Adtralza tralokinumab
Updated
07/04/2026
Medicine: Eurneffy epinephrine
Updated
07/04/2026
Page: Data protection and privacy at EMA
 Updated
07/04/2026
Document: European Medicines Agency's data protection notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme
 New
07/04/2026
Event: SPOR and XEVMPD status update webinar - Q2 2026
 Updated
07/04/2026
Page: Industry Standing Group
 Updated
07/04/2026
Document: Highlights - EMA - European Alliance of Associations for Rheumatology (EULAR) bilateral meeting - March 2026
 New
07/04/2026
Event: Electronic application form (eAF) Q&A clinic
 Updated
07/04/2026
Event: European Medicines Regulatory Network (EMRN) workshop on Geographic Atrophy endpoints
 Updated
07/04/2026
Document: Notices and alerts per role - CTIS Training Programme - Module 07
 Updated
07/04/2026
DHPC: Avtozma - direct healthcare professional communication (DHPC) tocilizumab
New
07/04/2026
Page: PRAC recommendations on safety signals
 Updated
07/04/2026
Document: New product information wording - Extracts from PRAC recommendations on signals adopted at the 9-12 March 2026 PRAC
 New
07/04/2026
Document: PRAC recommendations on signals adopted at the 9-12 March 2026 PRAC meeting
 New
07/04/2026
Document: List of signals discussed at PRAC since September 2012
 Updated
01/04/2026
Medicine: Keppra levetiracetam
Updated
01/04/2026
Medicine: Ryzneuta efbemalenograstim alfa
Updated
01/04/2026
Medicine: Ilumira lutetium (177Lu) chloride
Updated
01/04/2026
Medicine: RoActemra tocilizumab
Updated
01/04/2026
Medicine: Firazyr icatibant
Updated
01/04/2026
Document: Minutes of the COMP meeting 17-19 February 2026
 New
01/04/2026
Page: Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products - Scientific guideline
 Updated
01/04/2026
Document: Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ - Revision 2
 New
01/04/2026
Document: Joint Controllership Arrangement with regard to the Union product database (UPD)
 Updated
01/04/2026
Document: Records of data processing activity for the Union Product Database
 Updated
01/04/2026
Document: Policy 82: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products
 Updated
01/04/2026
Document: European Medicines Agency’s data protection notice for the exchange of information during the Critical Medicines Vulnerability Assessment exercise
 New
01/04/2026
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 March 2026
 New
01/04/2026
Event: Management Board meeting: 12 March 2026
 Updated
01/04/2026
Page: Medicines for human use under evaluation
 Updated
01/04/2026
Document: Orphan medical devices regular process: Guide for applicants
 New
01/04/2026
Document: Orphan medical devices regular process: 2026 timetable
 New
01/04/2026
Document: Clinical advice request: Template for applicants
 New
01/04/2026
Document: Orphan status request: Template for applicants
 New
01/04/2026
Medicine: Eliquis apixaban
Updated
01/04/2026
Medicine: Winrevair sotatercept
Updated
01/04/2026
Event: Workshop on the use of external controls for evidence generation in regulatory decision-making
 Updated
01/04/2026
Medicine: LysaKare arginine; lysine
Updated
01/04/2026
Event: Workshop on Vulnerability Assessment
 Updated
01/04/2026
Page: Scientific Advisory Group on Immune and Inflammatory Diseases
 Updated
01/04/2026
Document: Implantable cardiac devices (various) - Notified body 2797 - 15/07/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
 New
01/04/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated