| 30/04/2025 | Page: Periodic safety update reports (PSURs) | Updated |
| 30/04/2025 | Document: Report - Industry stakeholders and EU network experts surveys on early engagement fostering innovation | Updated |
| 30/04/2025 | Herbal: Uvae ursi folium - herbal medicinal product | Updated |
| 30/04/2025 | Herbal: Meliloti herba - herbal medicinal product | Updated |
| 30/04/2025 | Herbal: Lupuli flos - herbal medicinal product | Updated |
| 30/04/2025 | Herbal: Gentianae radix - herbal medicinal product | Updated |
| 30/04/2025 | Medicine: Extavia | Updated |
| 30/04/2025 | Herbal: Cisti cretici herba - herbal medicinal product | Updated |
| 30/04/2025 | Medicine: Vyvgart | Updated |
| 30/04/2025 | Medicine: Levetiracetam Accord | Updated |
| 30/04/2025 | Medicine: Dupixent | Updated |
| 30/04/2025 | Medicine: Qtern | Updated |
| 30/04/2025 | Document: Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b | New |
| 30/04/2025 | Medicine: Keytruda | Updated |
| 30/04/2025 | Medicine: Filspari | Updated |
| 30/04/2025 | Document: EMA Agile governance model | Updated |
| 30/04/2025 | Medicine: Quviviq | Updated |
| 30/04/2025 | Document: Business process description for scientific meeting management | Updated |
| 30/04/2025 | Document: Business process description for expert management | Updated |
| 30/04/2025 | Page: ICH Q1 guideline on stability testing of drug substances and drug products | New |
| 30/04/2025 | Document: Extavia : EPAR - Public assessment report | Updated |
| 29/04/2025 | Medicine: Cimzia | Updated |
| 29/04/2025 | Medicine: Hyrimoz | Updated |
| 29/04/2025 | Medicine: Alofisel | Updated |
| 29/04/2025 | Document: CTIS newsflash - 29 April 2025 | New |
| 29/04/2025 | Document: List of eligible industry stakeholder organisations | Updated |
| 29/04/2025 | Event: SPOR and XEVMPD status update webinar | Updated |
| 29/04/2025 | Medicine: Hefiya | Updated |
| 29/04/2025 | Medicine: Zilbrysq | Updated |
| 29/04/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 29/04/2025 | News: EMA closed 1 May | New |
| 29/04/2025 | Medicine: Xenleta | Updated |
| 29/04/2025 | Event: Twelfth Industry Standing Group (ISG) meeting | Updated |
| 29/04/2025 | Page: Industry annual bilateral meetings | Updated |
| 29/04/2025 | Page: Clinical Trials Information System | Updated |
| 28/04/2025 | Medicine: Shingrix | Updated |
| 28/04/2025 | Medicine: Hympavzi | Updated |
| 28/04/2025 | News: Management Board meeting on possible renewal of Executive Director’s mandate | New |
| 28/04/2025 | Medicine: Spedra | Updated |
| 28/04/2025 | Medicine: Bimzelx | Updated |
| 28/04/2025 | Medicine: Zykadia | Updated |
| 28/04/2025 | Document: Organisation chart: Information Management | Updated |
| 28/04/2025 | Document: Minutes of the CAT meeting 19-21 March 2025 | New |
| 28/04/2025 | Page: Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline | Updated |
| 28/04/2025 | Document: Overview of comments received on guideline on clinical investigation of medicinal products in the treatment of epileptic disorders (CHMP/EWP/566/98 Rev.3) | New |
| 28/04/2025 | Medicine: Eliquis | Updated |
| 28/04/2025 | Document: Agenda - Extraordinary Management Board meeting: 28 April 2025 | New |
| 28/04/2025 | Medicine: Twynsta | Updated |
| 28/04/2025 | Page: Vaccine-preventable diseases: key facts | New |
| 28/04/2025 | Page: Human papillomavirus (HPV) | New |
| 28/04/2025 | Page: Measles | New |
| 28/04/2025 | Medicine: Dazublys | New |
| 28/04/2025 | Document: EudraVigilance Expert Working Group (EV-EWG) work programme 2025-2026 | Updated |
| 28/04/2025 | Post-authorisation: Xofluza - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Medicine: Enjaymo | Updated |
| 25/04/2025 | Medicine: Piasky | Updated |
| 25/04/2025 | Medicine: Alunbrig | Updated |
| 25/04/2025 | Medicine: Pemetrexed Pfizer (previously Pemetrexed Hospira) | Updated |
| 25/04/2025 | Medicine: Azacitidine Mylan | Updated |
| 25/04/2025 | Medicine: Elocta | Updated |
| 25/04/2025 | Medicine: RotaTeq | Updated |
| 25/04/2025 | Medicine: Ziihera | New |
| 25/04/2025 | Post-authorisation: Veklury - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Post-authorisation: Calquence - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Post-authorisation: Vyvgart - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Post-authorisation: Jivi - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Post-authorisation: Cystadrops - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Medicine: Denosumab BBL | New |
| 25/04/2025 | Medicine: Duvyzat | New |
| 25/04/2025 | Medicine: Enwylma | New |
| 25/04/2025 | Medicine: Vevzuo | New |
| 25/04/2025 | Medicine: Oczyesa | New |
| 25/04/2025 | Post-authorisation: Adcetris - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Medicine: Attrogy | New |
| 25/04/2025 | Post-authorisation: Zoonotic Influenza Vaccine Seqirus - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Medicine: Dazluma | New |
| 25/04/2025 | Post-authorisation: Ngenla - withdrawal of application for variation to marketing authorisation | New |
| 25/04/2025 | Post-authorisation: Adempas - opinion on variation to marketing authorisation | New |
| 25/04/2025 | Medicine: Tepezza | New |
| 25/04/2025 | Medicine: Sephience | New |
| 25/04/2025 | Medicine: Junod | New |
| 25/04/2025 | Medicine: Izamby | New |
| 25/04/2025 | Medicine: Denbrayce | New |
| 25/04/2025 | Medicine: Zadenvi | New |
| 25/04/2025 | Medicine: Yaxwer | New |
| 25/04/2025 | Orphan: EU/3/21/2527 - orphan designation for treatment of cystic fibrosis | Updated |
| 25/04/2025 | Orphan: EU/3/22/2640 - orphan designation for treatment of ATTR amyloidosis | Updated |
| 25/04/2025 | Orphan: EU/3/21/2458 - orphan designation for treatment of biliary tract cancer | Updated |
| 25/04/2025 | Orphan: EU/3/09/645 - orphan designation for treatment of acromegaly | Updated |
| 25/04/2025 | Orphan: EU/3/21/2435 - orphan designation for treatment of hyperphenylalaninemia | Updated |
| 25/04/2025 | News: New treatment against Duchenne muscular dystrophy | New |
| 25/04/2025 | News: First treatment against severe thyroid eye disease | New |
| 25/04/2025 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2025 | New |
| 25/04/2025 | PIP: EMEA-000780-PIP01-09-M07 - paediatric investigation plan | Updated |
| 25/04/2025 | PIP: EMEA-001625-PIP02-21-M03 - paediatric investigation plan | Updated |
| 25/04/2025 | PIP: EMEA-002282-PIP01-17-M02 - paediatric investigation plan | Updated |
| 25/04/2025 | PIP: EMEA-002493-PIP01-18-M06 - paediatric investigation plan | Updated |
| 25/04/2025 | Event: Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V) | Updated |
| 25/04/2025 | Medicine: Avastin | Updated |
| 25/04/2025 | Medicine: Jaypirca | Updated |
| 25/04/2025 | Medicine: Afqlir | Updated |
| 24/04/2025 | Medicine: Cancidas (previously Caspofungin MSD) | Updated |
| 24/04/2025 | Medicine: Prevenar 13 | Updated |
| 24/04/2025 | DHPC: Opzelura - direct healthcare professional communication (DHPC) | New |
| 24/04/2025 | Medicine: Omlyclo | Updated |
| 24/04/2025 | Medicine: Prevenar 20 (previously Apexxnar) | Updated |
| 24/04/2025 | Medicine: Movymia | Updated |
| 24/04/2025 | Medicine: Kisqali | Updated |
| 24/04/2025 | Medicine: Wainzua | Updated |
| 24/04/2025 | Medicine: Brilique | Updated |
| 24/04/2025 | Document: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation (archive) | Updated |
| 24/04/2025 | Document: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation | New |
| 24/04/2025 | Orphan: EU/3/09/667 - orphan designation for treatment of anal fistula | Updated |
| 24/04/2025 | Medicine: Regkirona | Updated |
| 24/04/2025 | Medicine: Vevizye | Updated |
| 24/04/2025 | Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data | Updated |
| 23/04/2025 | Page: Procurement | Updated |
| 23/04/2025 | Medicine: Nilotinib Accord | Updated |
| 23/04/2025 | Medicine: Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) | Updated |
| 23/04/2025 | Medicine: Ngenla | Updated |
| 23/04/2025 | Medicine: Tysabri | Updated |
| 23/04/2025 | Medicine: Micardis | Updated |
| 23/04/2025 | Medicine: Pritor | Updated |
| 23/04/2025 | Medicine: Zinplava | Updated |
| 23/04/2025 | Medicine: Emend | Updated |
| 22/04/2025 | Medicine: Temodal | Updated |
| 22/04/2025 | Medicine: Ivemend | Updated |
| 22/04/2025 | Medicine: Kuvan | Updated |
| 22/04/2025 | Medicine: Zegalogue | Updated |
| 22/04/2025 | Document: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) | Updated |
| 22/04/2025 | Page: Policies and procedures | Updated |
| 22/04/2025 | Medicine: Lenvima | Updated |
| 22/04/2025 | Document: Business process description for variations and other related post-authorisation processes | New |
| 22/04/2025 | Document: Business process description for inspection coordination | New |
| 22/04/2025 | Document: Business process description for translations | New |
| 22/04/2025 | Document: Business process description for scientific advice | New |
| 22/04/2025 | Document: Business process description for sampling and testing of CAPs | New |
| 22/04/2025 | Document: Business process description for referral procedures | New |
| 22/04/2025 | Document: Business process description for quality defect and non-compliance management | New |
| 22/04/2025 | Document: Business process description for certificates of medicinal products | New |
| 22/04/2025 | Document: Business process description for parallel distribution | New |
| 22/04/2025 | Document: Business process description for medical devices | New |
| 22/04/2025 | Document: Business process description for pharmacovigilance | New |
| 22/04/2025 | Medicine: Evra | Updated |
| 22/04/2025 | Document: Business process description for paediatric medicines development | New |
| 22/04/2025 | Document: Business process description for orphan status management | New |
| 22/04/2025 | Document: Business process description for PSUSA and other related post-authorisation processes | New |
| 22/04/2025 | Document: Business process description for marketing authorisation and other related processes | New |
| 22/04/2025 | Document: Business process description for regulatory and scientific guidelines | New |
| 22/04/2025 | Document: Business process description for committee management | New |
| 22/04/2025 | Document: Template for late submission of ICSRs to EV | Updated |
| 22/04/2025 | Document: European Medicines Agency’s data protection notice for EudraVigilance Human (EV) | Updated |
| 22/04/2025 | Document: Qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials | Updated |
| 22/04/2025 | Medicine: Retacrit | Updated |
| 16/04/2025 | PSUSA: PSUSA/00002774/202408 - periodic safety update report single assessment | New |
| 16/04/2025 | PSUSA: PSUSA/00000027/202407 - periodic safety update report single assessment | New |
| 16/04/2025 | Medicine: Plavix | Updated |
| 16/04/2025 | Medicine: Pirfenidone Viatris | Updated |
| 16/04/2025 | Page: Variations requiring assessment (veterinary medicines) | Updated |
| 16/04/2025 | Medicine: Epysqli | Updated |
| 16/04/2025 | Medicine: Iscover | Updated |
| 16/04/2025 | Medicine: Elaprase | Updated |
| 16/04/2025 | Page: Medicine evaluation figures | Updated |
| 16/04/2025 | Document: Medicinal products for human use: monthly figures - March 2025 | New |
| 16/04/2025 | Medicine: Cometriq | Updated |
| 16/04/2025 | Page: ICH M15 guideline on general principles for model-informed drug development - Step 2b - Scientific guideline | Updated |
| 16/04/2025 | Document: European Medicines Agency’s Data Protection Notice for the operation of video-surveillance (CCTV) system | Updated |
| 16/04/2025 | Document: Record of data processing activity for video-surveillance (CCTV) system | Updated |
| 16/04/2025 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 March 2025 | Updated |
| 16/04/2025 | Document: Minutes of the CVMP meeting 11-13 March 2025 | New |
| 16/04/2025 | Medicine: Cabometyx | Updated |
| 16/04/2025 | Document: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin | Updated |
| 16/04/2025 | Page: Assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product - Scientific guideline | New |
| 15/04/2025 | PSUSA: PSUSA/00002920/202408 - periodic safety update report single assessment | New |
| 15/04/2025 | Medicine: Zefylti | Updated |
| 15/04/2025 | Medicine: Tamiflu | Updated |
| 15/04/2025 | Medicine: Inovelon | Updated |
| 15/04/2025 | Page: Fees payable to the European Medicines Agency | Updated |
| 15/04/2025 | Page: Fees payable to the European Medicines Agency: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices | New |
| 15/04/2025 | Page: Fees payable to the European Medicines Agency: Annual fees and remuneration | New |
| 15/04/2025 | Page: Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal products | New |
| 15/04/2025 | Page: Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use | New |
| 15/04/2025 | Page: Fees payable to the European Medicines Agency: General questions and answers | New |
| 15/04/2025 | Document: Pool of healthcare professional experts: list for 2024-2029 | New |
| 15/04/2025 | Document: Pool of patient and consumer experts: list for 2024-2029 | New |
| 15/04/2025 | Medicine: Mounjaro | Updated |
| 15/04/2025 | Medicine: Valdoxan | Updated |
| 15/04/2025 | Medicine: Omeprazole TriviumVet | Updated |
| 15/04/2025 | Medicine: Elmaro | Updated |
| 15/04/2025 | Medicine: Vectormune HVT-AIV | Updated |
| 15/04/2025 | Medicine: Mircera | Updated |
| 15/04/2025 | News: EMA business hours over Easter holiday period | New |
| 15/04/2025 | Herbal: Allii sativi bulbus - herbal medicinal product | Updated |
| 15/04/2025 | Herbal: Arnicae flos - herbal medicinal product | Updated |
| 15/04/2025 | Herbal: Crataegi folium cum flore - herbal medicinal product | Updated |
| 15/04/2025 | Page: Procedures for monograph and list entry establishment | Updated |
| 15/04/2025 | Herbal: Combination: Valerianae radix and Passiflorae herba - herbal medicinal product | Updated |
| 15/04/2025 | Document: Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herba | New |
| 15/04/2025 | Event: European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs) | Updated |
| 15/04/2025 | Medicine: Clopidogrel Viatris (previously Clopidogrel Taw Pharma) | Updated |
| 15/04/2025 | Document: Policy 26: Records management and archives policy | Updated |
| 15/04/2025 | Document: Procedural advice on paediatric applications | Updated |
| 15/04/2025 | Medicine: Prometax | Updated |
| 15/04/2025 | Page: Non-clinical Working Party | Updated |
| 15/04/2025 | Event: EMA’s 30th anniversary scientific conference - Medicines, regulation and the future | Updated |
| 15/04/2025 | Page: Nitrosamines Safety Operational Expert Group | Updated |
| 15/04/2025 | PSUSA: PSUSA/00000464/202407 - periodic safety update report single assessment | New |
| 14/04/2025 | Shortage: Dynastat | New |
| 14/04/2025 | Document: Agenda of the CAT meeting 14-16 April 2025 | New |
| 14/04/2025 | Medicine: Stelara | Updated |
| 14/04/2025 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting | Updated |
| 14/04/2025 | Page: Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline | Updated |
| 14/04/2025 | Document: Minimum inhibitory concentration (MIC) breakpoints | Updated |
| 14/04/2025 | Medicine: Rezolsta | Updated |
| 14/04/2025 | PIP: EMEA-001270-PIP01-12-M07 - paediatric investigation plan | Updated |
| 14/04/2025 | PIP: EMEA-001314-PIP01-12-M02 - paediatric investigation plan | Updated |
| 14/04/2025 | Page: Product-information (QRD) templates - Human | Updated |
| 14/04/2025 | Document: Quality Review of Documents (QRD) annotated template v11: Draft for public consultation | New |
| 14/04/2025 | Document: Quality Review of Documents (QRD) annotated template v11: Form for submission of comments to public consultation | New |
| 14/04/2025 | Document: Quality Review of Documents (QRD) annotated template v11: Draft for public consultation - track changes | New |
| 14/04/2025 | Document: Key information section in package leaflet of centrally authorised medicinal products: Public consultation | New |
| 14/04/2025 | PIP: EMEA-001539-PIP01-13-M06 - paediatric investigation plan | Updated |
| 14/04/2025 | PIP: EMEA-001579-PIP01-13-M06 - paediatric investigation plan | Updated |
| 14/04/2025 | PIP: EMEA-002741-PIP01-20-M02 - paediatric investigation plan | Updated |
| 14/04/2025 | PIP: EMEA-002338-PIP04-23 - paediatric investigation plan | New |
| 14/04/2025 | Page: Eligible patients and consumers organisations | Updated |
| 14/04/2025 | PIP: EMEA-002915-PIP01-20-M03 - paediatric investigation plan | Updated |
| 14/04/2025 | PIP: EMEA-003420-PIP01-23 - paediatric investigation plan | New |
| 14/04/2025 | News: Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU | New |
| 14/04/2025 | Page: Availability of medicines before and during crises | Updated |
| 14/04/2025 | Document: Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals | New |
| 14/04/2025 | Medicine: Skojoy | Updated |
| 14/04/2025 | Medicine: Vydura | Updated |
| 14/04/2025 | PIP: EMEA-003423-PIP02-23 - paediatric investigation plan | New |
| 14/04/2025 | Document: PhV non-compliance notification contact points at National Competent Authority (NCA) level | Updated |
| 14/04/2025 | Page: Contacts at the European Medicines Agency | Updated |
| 11/04/2025 | Medicine: Herzuma | Updated |
| 11/04/2025 | Medicine: Exelon | Updated |
| 11/04/2025 | Document: Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6) | Updated |
| 11/04/2025 | Medicine: Cinqaero | Updated |
| 11/04/2025 | Medicine: Edurant | Updated |
| 11/04/2025 | Medicine: Effentora | Updated |
| 11/04/2025 | Medicine: Fabhalta | Updated |
| 11/04/2025 | Page: Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline | Updated |
| 11/04/2025 | Page: Medical devices | Updated |
| 11/04/2025 | Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies | Updated |
| 11/04/2025 | Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes | New |
| 11/04/2025 | Medicine: Entyvio | Updated |
| 11/04/2025 | Document: Overview of NCAs participating in the voluntary Simultaneous National Scientific Advice (SNSA) project | Updated |
| 11/04/2025 | EU-M4all: Aluvia - opinion on medicine for use outside EU | Updated |
| 11/04/2025 | Page: Clinical investigation of medicinal products in the treatment of depression - Scientific guideline | Updated |
| 11/04/2025 | Medicine: Xermelo | Updated |
| 11/04/2025 | Medicine: Emevet | New |
| 11/04/2025 | Medicine: Nobilis Multriva Gm+REOm | New |
| 11/04/2025 | Medicine: Nobilis Multriva IBm+ND | New |
| 11/04/2025 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025 | New |
| 11/04/2025 | PSUSA: PSUSA/00000742/202408 - periodic safety update report single assessment | New |
| 11/04/2025 | PSUSA: PSUSA/00000986/202409 - periodic safety update report single assessment | New |
| 11/04/2025 | Medicine: Kisunla | Updated |
| 11/04/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025 | New |
| 11/04/2025 | Page: Assessment templates and guidance | Updated |
| 11/04/2025 | Medicine: Sialanar | Updated |
| 11/04/2025 | Medicine: Orphacol | Updated |
| 11/04/2025 | Page: Emergency Task Force (ETF) | Updated |
| 11/04/2025 | Document: Composition of the Emergency Task Force (ETF) for preparedness | New |
| 11/04/2025 | Document: Superseded - Composition of the Emergency Task Force (ETF) for preparedness | Updated |
| 11/04/2025 | Document: Rules of procedure of the Emergency Task Force (ETF) | New |
| 11/04/2025 | Document: Superseded - Rules of procedure of the Emergency Task Force (ETF) | Updated |
| 11/04/2025 | Medicine: Moventig | Updated |
| 10/04/2025 | PSUSA: PSUSA/00010856/202408 - periodic safety update report single assessment | New |
| 10/04/2025 | Medicine: Akynzeo | Updated |
| 10/04/2025 | Medicine: Avonex | Updated |
| 10/04/2025 | Document: QRD veterinary Appendix I - Adverse event (PhV) MSs reporting details | Updated |
| 10/04/2025 | Medicine: Trepulmix | Updated |
| 10/04/2025 | Medicine: Ebglyss | Updated |
| 10/04/2025 | Medicine: Kaftrio | Updated |
| 10/04/2025 | Medicine: Darzalex | Updated |
| 10/04/2025 | Event: 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work plan | Updated |
| 10/04/2025 | Shortage: Zirabev | Updated |
| 10/04/2025 | Document: Innovation Task Force (ITF) briefing meeting request form | Updated |
| 10/04/2025 | Medicine: Relvar Ellipta | Updated |
| 10/04/2025 | Medicine: Kaletra | Updated |
| 10/04/2025 | Document: Minutes - PDCO minutes of the 25-28 February 2025 meeting | New |
| 10/04/2025 | Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-19 March 2025 | New |
| 10/04/2025 | Document: Overview of comments received on the draft revision of EMA’s Policy on handling competing interests of scientific committee members and experts | Updated |
| 10/04/2025 | Medicine: Pavblu | Updated |
| 10/04/2025 | Document: Electronic submission of Article 57(2) data: questions and answers | Updated |
| 10/04/2025 | 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 |
| 10/04/2025 | Document: List of industry subject matter experts and list of planned calls for industry subject matter experts | Updated |
| 09/04/2025 | Medicine: Esbriet | Updated |
| 09/04/2025 | Medicine: Ronapreve | Updated |
| 09/04/2025 | Medicine: Hulio | Updated |
| 09/04/2025 | Document: Minutes of the PRAC meeting 10-13 February 2025 | New |
| 09/04/2025 | Medicine: Competact | Updated |
| 09/04/2025 | News: EU recommendations for 2025/2026 seasonal flu vaccine composition | Updated |
| 09/04/2025 | Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 March 2025 | New |
| 09/04/2025 | Medicine: Vyloy | Updated |
| 09/04/2025 | Medicine: Besremi | Updated |
| 09/04/2025 | Medicine: Talmanco (previously Tadalafil Generics) | Updated |
| 09/04/2025 | Document: Minutes of the PRAC meeting 28-31 October 2024 | Updated |
| 09/04/2025 | Document: Minutes of the PRAC meeting 25-28 November 2024 | Updated |
| 09/04/2025 | Document: Minutes of the PRAC meeting 2-5 September 2024 | Updated |
| 09/04/2025 | Document: Minutes of the PRAC meeting 13-16 May 2024 | Updated |
| 09/04/2025 | Medicine: Quinsair | Updated |
| 09/04/2025 | Medicine: Rasagiline ratiopharm | Updated |
| 09/04/2025 | Orphan: EU/3/20/2305 - orphan designation for treatment of myelodysplastic syndromes | Updated |
| 09/04/2025 | Document: ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b | New |
| 09/04/2025 | Page: ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline | New |
| 09/04/2025 | Orphan: EU/3/21/2550 - orphan designation for treatment of soft tissue sarcoma | Updated |
| 09/04/2025 | Orphan: EU/3/19/2232 - orphan designation for treatment of amyotrophic lateral sclerosis | Updated |
| 09/04/2025 | Orphan: EU/3/24/2902 - orphan designation for treatment of mesothelioma | Updated |
| 09/04/2025 | Orphan: EU/3/21/2497 - orphan designation for treatment of diffuse large B-cell lymphoma | Updated |
| 08/04/2025 | Medicine: Loqtorzi | Updated |
| 08/04/2025 | Medicine: Kentera (previously Oxybutynin Nicobrand) | Updated |
| 08/04/2025 | Medicine: Azilect | Updated |
| 08/04/2025 | Medicine: Pregabalin Viatris Pharma (previously Pregabalin Pfizer) | Updated |
| 08/04/2025 | Page: Real-world evidence | Updated |
| 08/04/2025 | Medicine: Refixia | Updated |
| 08/04/2025 | Medicine: Sugammadex Adroiq | Updated |
| 08/04/2025 | Medicine: Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) | Updated |
| 08/04/2025 | Medicine: Ontozry | Updated |
| 08/04/2025 | Medicine: Evrenzo | Updated |
| 08/04/2025 | Medicine: Lysodren | Updated |
| 08/04/2025 | Page: Animal health practitioners | New |
| 08/04/2025 | Document: Agenda of the CVMP meeting 8-10 April 2025 | New |
| 08/04/2025 | Document: Veterinary medicines safety day: How to report adverse events - simple guide | New |
| 08/04/2025 | Document: Veterinary medicines safety day: Adverse event reporting in the EU - presentation | New |
| 08/04/2025 | Document: Veterinary medicines safety day: Social media infocards | New |
| 08/04/2025 | Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers | Updated |
| 08/04/2025 | Event: Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicines | Updated |
| 07/04/2025 | Medicine: Avtozma | Updated |
| 07/04/2025 | Medicine: Taltz | Updated |
| 07/04/2025 | Medicine: Fluenz | Updated |
| 07/04/2025 | Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 March 2025 PRAC | New |
| 07/04/2025 | Document: PRAC recommendations on signals adopted at the 10-13 March 2025 meeting | New |
| 07/04/2025 | Page: Medicine shortage communications (MSC) | Updated |
| 07/04/2025 | Document: Medicine shortage communication (MSC): Mimpara (cinacalcet) | New |
| 07/04/2025 | Shortage: Mimpara | New |
| 07/04/2025 | Medicine: Elrexfio | Updated |
| 07/04/2025 | Medicine: Tivdak | Updated |
| 07/04/2025 | Orphan: EU/3/25/3039 - orphan designation for treatment of haemophilia B | New |
| 07/04/2025 | Orphan: EU/3/25/3043 - orphan designation for treatment of primary IgA nephropathy | New |
| 07/04/2025 | Orphan: EU/3/25/3042 - orphan designation for treatment of Rett syndrome | New |
| 07/04/2025 | Orphan: EU/3/25/3041 - orphan designation for treatment of Marfan syndrome | New |
| 07/04/2025 | Orphan: EU/3/25/3038 - orphan designation for treatment of haemophilia B | New |
| 04/04/2025 | Event: Thirteenth meeting of the industry stakeholder platform on research and development support | Updated |
| 04/04/2025 | Document: Highlight report - 13th Industry stakeholder platform on research and development support | New |
| 04/04/2025 | Document: SMS guidance for external users | Updated |
| 04/04/2025 | PSUSA: PSUSA/00002942/202406 - periodic safety update report single assessment | New |
| 04/04/2025 | Medicine: Ajovy | Updated |
| 04/04/2025 | Medicine: Opsumit | Updated |
| 04/04/2025 | Medicine: SomaKit TOC | Updated |
| 04/04/2025 | Medicine: Rivastigmine Sandoz | Updated |
| 04/04/2025 | Medicine: Rivastigmine Hexal | Updated |
| 04/04/2025 | Medicine: Rivastigmine 1 A Pharma | Updated |
| 04/04/2025 | Orphan: EU/3/25/3044 - orphan designation for treatment of myelodysplastic syndromes | New |
| 04/04/2025 | Medicine: Sitagliptin / Metformin hydrochloride Mylan | Updated |
| 04/04/2025 | Orphan: EU/3/25/3037 - orphan designation for treatment of non-traumatic spontaneous intracerebral haemorrhage | New |
| 04/04/2025 | Medicine: Rxulti | Updated |
| 04/04/2025 | Orphan: EU/3/20/2277 - orphan designation for treatment of multiple myeloma | Updated |
| 04/04/2025 | Orphan: EU/3/24/3002 - orphan designation for treatment of in solid organ transplantation | Updated |
| 04/04/2025 | Orphan: EU/3/25/3040 - orphan designation for treatment of bradykinin-mediated angioedema | New |
| 04/04/2025 | Medicine: Reblozyl | Updated |
| 04/04/2025 | Document: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes | Updated |
| 04/04/2025 | Medicine: Vildagliptin / Metformin hydrochloride Accord | Updated |
| 03/04/2025 | Medicine: Cejemly | Updated |
| 03/04/2025 | Medicine: Lutathera | Updated |
| 03/04/2025 | Medicine: Perjeta | Updated |
| 03/04/2025 | Medicine: MabThera | Updated |
| 03/04/2025 | Document: Antimicrobial Sales and Use (ASU) Platform: Release notes | Updated |
| 03/04/2025 | Medicine: Jinarc | Updated |
| 03/04/2025 | Medicine: Seffalair Spiromax | Updated |
| 03/04/2025 | Medicine: ellaOne | Updated |
| 03/04/2025 | Medicine: Camcevi | Updated |
| 03/04/2025 | Medicine: Tukysa | Updated |
| 03/04/2025 | Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes | New |
| 03/04/2025 | Document: Journey towards a roadmap for regulatory guidance on real-world evidence | New |
| 03/04/2025 | Medicine: Litak | Updated |
| 03/04/2025 | Medicine: Yondelis | Updated |
| 03/04/2025 | Medicine: Copiktra | Updated |
| 03/04/2025 | News: Clinical Trials Information System designated as WHO primary registry | New |
| 02/04/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 02/04/2025 | Medicine: Jardiance | Updated |
| 02/04/2025 | PIP: EMEA-002656-PIP01-19-M01 - paediatric investigation plan | Updated |
| 02/04/2025 | PIP: EMEA-002565-PIP02-19-M01 - paediatric investigation plan | Updated |
| 02/04/2025 | Medicine: Pelmeg | Updated |
| 02/04/2025 | Document: Joint HTAb-regulatory perspectives on understanding evidence challenges, managing uncertainties and exploring potential solutions | New |
| 02/04/2025 | Medicine: BroPair Spiromax | Updated |
| 02/04/2025 | Page: Biosimilar medicines: Overview | Updated |
| 02/04/2025 | Page: Tolvaptan product-specific bioequivalence guidance | New |
| 02/04/2025 | PIP: EMEA-000551-PIP04-21-M03 - paediatric investigation plan | Updated |
| 02/04/2025 | PIP: EMEA-002121-PIP03-19-M02 - paediatric investigation plan | Updated |
| 02/04/2025 | PIP: EMEA-000237-PIP01-08-M12 - paediatric investigation plan | Updated |
| 02/04/2025 | PIP: EMEA-002234-PIP01-17-M02 - paediatric investigation plan | Updated |
| 02/04/2025 | Document: Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP) | Updated |
| 02/04/2025 | Document: Mandate, objectives and composition of the Patients and Consumers Working Party (PCWP) | Updated |
| 02/04/2025 | Document: Mandate, objectives and composition of the Healthcare Professionals Working Party (HCPWP) | Updated |
| 02/04/2025 | Event: Fourth listen-and-learn focus group meeting of the Quality Innovation Group | Updated |
| 01/04/2025 | Page: Data in regulation: Big data and other sources | Updated |
| 01/04/2025 | PIP: EMEA-003523-PIP01-23 - paediatric investigation plan | New |
| 01/04/2025 | Medicine: Bortezomib Accord | Updated |
| 01/04/2025 | Medicine: Slenyto | Updated |
| 01/04/2025 | PIP: EMEA-003515-PIP01-23 - paediatric investigation plan | New |
| 01/04/2025 | PIP: EMEA-003299-PIP02-22 - paediatric investigation plan | New |
| 01/04/2025 | PIP: EMEA-003522-PIP01-23 - paediatric investigation plan | New |
| 01/04/2025 | PIP: EMEA-002205-PIP02-23 - paediatric investigation plan | New |
| 01/04/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025 | Updated |
| 01/04/2025 | Medicine: Glyxambi | Updated |
| 01/04/2025 | Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification | Updated |
| 01/04/2025 | Medicine: Zubsolv | Updated |
| 01/04/2025 | News: Streamlining development and assessment of biosimilar medicines | New |
| 01/04/2025 | Page: Reflection paper on a tailored clinical approach in biosimilar development | Updated |
| 01/04/2025 | Document: Reflection paper on a tailored clinical approach in biosimilar development | New |
| 01/04/2025 | Medicine: Evista | Updated |
| 01/04/2025 | Shortage: RoActemra | Updated |
| 01/04/2025 | Document: IRIS guide to registration and RPIs | Updated |
| 01/04/2025 | Document: Organisation chart: Veterinary Medicines | Updated |
| 01/04/2025 | Document: Minutes of the CAT meeting 19-21 February 2025 | New |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR API | Updated |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS) | Updated |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for MAH | Updated |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for Sponsors | Updated |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Substance Management Service (SMS) | Updated |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : SPOR Data Governance | Updated |
| 01/04/2025 | Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Service (OMS) | Updated |
| 01/04/2025 | Document: Template - Request for advice on the orphan device status pursuant to Article 61(2) of Regulation (EU) 2017/745 and MDCG 2024-10 | Updated |
| 01/04/2025 | Document: Template - Request for advice on the clinical development strategy or clinical data required for the clinical evaluation pursuant to Article 61(2) or Article 106(11) of Regulation (EU) 2017/745 and MDCG 2024-10 on from the Expert Panels | Updated |
| 01/04/2025 | PIP: EMEA-003516-PIP01-23 - paediatric investigation plan | New |
| 01/04/2025 | Document: Start of procedure: Extension of marketing authorisation (28 February 2025 - 27 March 2025) | New |
| 01/04/2025 | Document: Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (28 February 2025 - 27 March 2025) | New |
| 01/04/2025 | Document: Scientific advice and protocol assistance adopted during the CHMP meeting 24-27 March 2025 | New |
| 01/04/2025 | Document: Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool | Updated |
| 01/04/2025 | Event: ICMRA Summit 2025 | New |
| 01/04/2025 | Herbal: Salicis cortex - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Psyllii semen - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Harpagophyti radix - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Hamamelidis cortex - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Equiseti herba - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Hamamelidis folium et cortex aut ramunculus destillatum - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Combination: Valerianae radix and Lupuli flos - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Carvi fructus - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Hamamelidis folium - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Carvi aetheroleum - herbal medicinal product | Updated |
| 01/04/2025 | Herbal: Althaeae radix - herbal medicinal product | Updated |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Valerianae radix and Lupuli flos | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Salicis cortex | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Psyllii semen | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Harpagophyti radix | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Hamamelidis folium et cortex aut ramunculus destillatum | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Hamamelidis folium | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Hamamelidis cortex | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Equiseti herba | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Carvi fructus | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Carvi aetheroleum | New |
| 01/04/2025 | Document: Call for scientific data for the periodic review of the monograph on Althaeae radix | New |
