DateContentStatus
19/12/2024 Shortage: CyanokitNew
19/12/2024 Medicine: Nobivac L4Updated
19/12/2024 Medicine: Versican Plus DHPPiUpdated
19/12/2024 Medicine: Versican Plus DHPPi/L4Updated
19/12/2024 Page: Trametinib product-specific bioequivalence guidelineNew
19/12/2024 Medicine: IdelvionUpdated
19/12/2024 Medicine: Axitinib AccordUpdated
19/12/2024 Medicine: CarbagluUpdated
19/12/2024 Medicine: Purevax RCP FeLVUpdated
19/12/2024 Medicine: Purevax RCPUpdated
19/12/2024 Medicine: Purevax FeLVUpdated
19/12/2024 Document: Article 57 product dataUpdated
19/12/2024 DHPC: Alofisel - direct healthcare professional communication (DHPC)New
18/12/2024 Medicine: VekluryUpdated
18/12/2024 Page: Frequently asked questions about parallel distributionUpdated
18/12/2024 Medicine: VanflytaUpdated
18/12/2024 Medicine: SimulectUpdated
18/12/2024 Medicine: TravatanUpdated
18/12/2024 Medicine: Zyprexa VelotabUpdated
18/12/2024 Medicine: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)Updated
18/12/2024 Medicine: VoncentoUpdated
18/12/2024 Document: Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568New
18/12/2024 Medicine: RespreezaUpdated
18/12/2024 Medicine: PiaskyUpdated
18/12/2024 Medicine: AfstylaUpdated
18/12/2024 Page: Assessment templates and guidance (veterinary medicines)Updated
18/12/2024 Document: Template - CVMP member comments on rapporteur’s reportsNew
18/12/2024 Medicine: TakhzyroUpdated
18/12/2024 Medicine: HympavziUpdated
18/12/2024 Medicine: VokanametUpdated
18/12/2024 Page: Data quality framework for medicines regulationUpdated
18/12/2024 Medicine: OntozryUpdated
18/12/2024 Page: Dexmedetomidine AccordNew
18/12/2024 Medicine: LynparzaUpdated
18/12/2024 Medicine: InvokanaUpdated
18/12/2024 Medicine: GivlaariUpdated
18/12/2024 Medicine: Nintedanib AccordUpdated
18/12/2024 Medicine: Sapropterin DipharmaUpdated
18/12/2024 Event: Seventh European Medicines Agency (EMA) and EFPIA bilateral meeting Updated
18/12/2024 Document: Highlights - Seventh European Medicines Agency (EMA) EFPIA bilateral meetingNew
18/12/2024 Page: Periodic safety update reports (PSURs)Updated
18/12/2024 Event: Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meetingUpdated
18/12/2024 Document: Highlights - Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meetingNew
18/12/2024 Medicine: Firdapse (previously Zenas)Updated
18/12/2024 DHPC: Keppra - direct healthcare professional communication (DHPC)New
18/12/2024 News: A common EU approach to data transparency in medicine regulationNew
18/12/2024 Document: Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: ...Updated
18/12/2024 Medicine: VevizyeUpdated
18/12/2024 Event: Public event: advancing regulatory science researchUpdated
18/12/2024 Document: Call for expression of interest for Academia to participate in the European Platform for Regulatory Science Research New
18/12/2024 Medicine: SigniforUpdated
18/12/2024 Medicine: WilzinUpdated
18/12/2024 Event: Fifth EMA/HMA Big Data Stakeholder ForumUpdated
18/12/2024 Document: Minutes of the CHMP meeting 22-25 July 2024New
18/12/2024 Page: ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Scientific guidelineUpdated
18/12/2024 Document: ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 5New
18/12/2024 Document: Frequently asked questions about parallel distributionUpdated
17/12/2024 Medicine: VizimproUpdated
17/12/2024 Page: HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (2016-2024)Updated
17/12/2024 Document: Data access to medicinal products for human use - Chapter 5 Annex A: Product data elements accessible by stakeholder groupUpdated
17/12/2024 Page: Medicine shortages and availability issues: guidance for regulatorsUpdated
17/12/2024 Document: Good practice guidance for communication to the public on medicines’ availability issuesUpdated
17/12/2024 Document: Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics - Revision 1New
17/12/2024 Document: EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)Updated
17/12/2024 Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodiesUpdated
17/12/2024 Document: Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 ApplicationUpdated
17/12/2024 Document: EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 2New
17/12/2024 Event: Quarterly system demo - Q4 2024Updated
17/12/2024 Medicine: UptraviUpdated
17/12/2024 Referral: Oxbryta - referralUpdated
17/12/2024 Medicine: NeuraceqUpdated
17/12/2024 Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Environmental Risk Assessment Working Party (ERAWP) 2025Updated
17/12/2024 Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2Updated
17/12/2024 Shortage: Norditropin NordiFlexUpdated
17/12/2024 News: Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulationNew
17/12/2024 Page: Biosimilar medicines: marketing authorisationUpdated
17/12/2024 Page: Pre-authorisation guidanceUpdated
17/12/2024 Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureUpdated
17/12/2024 Document: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications: document with track changesUpdated
17/12/2024 Document: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applicationsUpdated
17/12/2024 Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changesUpdated
17/12/2024 Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)Updated
17/12/2024 Document: Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical deviceUpdated
17/12/2024 Page: Type-IB variations: questions and answersUpdated
17/12/2024 Page: Type-II variations: questions and answersUpdated
17/12/2024 Page: Extensions of marketing authorisations: questions and answersUpdated
17/12/2024 Page: Grouping of variations: questions and answersUpdated
17/12/2024 Page: Worksharing: questions and answersUpdated
17/12/2024 Page: Transfer of marketing authorisation: questions and answersUpdated
17/12/2024 Page: Generic and hybrid applicationsUpdated
17/12/2024 Page: Renewal and annual re-assessment of marketing authorisationUpdated
17/12/2024 Page: Type-IA variations: questions and answersUpdated
17/12/2024 Document: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)Updated
17/12/2024 Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changesUpdated
17/12/2024 Document: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applicationsUpdated
17/12/2024 Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedureUpdated
17/12/2024 News: EMA business hours over holiday periodNew
17/12/2024 Page: ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guidelineUpdated
17/12/2024 Document: Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised productsUpdated
17/12/2024 Document: CTIS newsflash - 17 December 2024New
17/12/2024 Medicine: TyverbUpdated
17/12/2024 Medicine: DurystaUpdated
16/12/2024 Document: Big Data Steering Group (BDSG): 2024 reportNew
16/12/2024 Herbal: Combination: Species pectorales - herbal medicinal productUpdated
16/12/2024 Medicine: FluadUpdated
16/12/2024 Medicine: HefiyaUpdated
16/12/2024 Medicine: HyrimozUpdated
16/12/2024 Document: FAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10Updated
16/12/2024 Medicine: UzpruvoUpdated
16/12/2024 Medicine: Pemetrexed Pfizer (previously Pemetrexed Hospira)Updated
16/12/2024 DHPC: Medroxyprogesterone acetate - direct healthcare professional communication (DHPC)New
16/12/2024 Medicine: NaglazymeUpdated
16/12/2024 Medicine: ExjadeUpdated
16/12/2024 News: Successful pilot paves the way for implementation of ePINew
16/12/2024 Page: Electronic product information (ePI)Updated
16/12/2024 Page: Applying for marketing authorisation: orphan medicinesUpdated
16/12/2024 Document: Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicinesNew
16/12/2024 Document: Union list of critical medicinesNew
16/12/2024 Medicine: VedropUpdated
16/12/2024 Page: Applying for orphan designationUpdated
16/12/2024 Page: Requesting scientific advice or protocol assistance from EMAUpdated
16/12/2024 Document: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changesUpdated
16/12/2024 Medicine: ZaviceftaUpdated
16/12/2024 Medicine: LucentisUpdated
16/12/2024 Medicine: EvrenzoUpdated
16/12/2024 Page: Union list of critical medicinesUpdated
16/12/2024 Document: Questions and answers on the Union list of critical medicinesUpdated
13/12/2024 Page: Artificial intelligenceUpdated
13/12/2024 Page: Live recombinant vector vaccines for veterinary use - Scientific guidelineUpdated
13/12/2024 Page: Requesting certificatesUpdated
13/12/2024 Medicine: Riltrava AerosphereUpdated
13/12/2024 Medicine: Trixeo AerosphereUpdated
13/12/2024 Page: Questions and answers for biological medicinal productsUpdated
13/12/2024 Medicine: FlucelvaxUpdated
13/12/2024 News: EMA Management Board: highlights of December 2024 meetingNew
13/12/2024 Document: 2025 Work plan for the European Sales and Use of Antimicrobials in veterinary medicine Working Group (ESUAvet WG)New
13/12/2024 Event: Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion New
13/12/2024 Document: Mandate, objectives, and rules of procedure for the European Specialised Expert Community (ESEC) for MethodologyUpdated
13/12/2024 Document: Highlight report - Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesNew
13/12/2024 Page: Antimicrobials Working PartyUpdated
13/12/2024 Medicine: KizfizoUpdated
13/12/2024 Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Scientific Advice Working Party (SAWP-V) for 2025New
13/12/2024 Document: Minutes - HMA-EMA joint Big Data Steering Group teleconference - 15 November 2024New
13/12/2024 Page: Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater - Scientific guidelineUpdated
13/12/2024 Document: PRAC advice templateUpdated
13/12/2024 Document: Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6Updated
13/12/2024 Document: Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwaterUpdated
13/12/2024 Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Immunologicals Working Party (IWP) 2025Updated
13/12/2024 Document: Medicinal products for human use: Monthly figures - November 2024New
13/12/2024 Document: Work plan for the CVMP Novel Therapies & Technologies Working Party (NTWP) 2025Updated
13/12/2024 Page: Paediatric investigation plans: questions and answersUpdated
13/12/2024 Document: Scientific recommendations on classification of advanced therapy medicinal productsUpdated
13/12/2024 Page: Maximum residue limits (MRL)Updated
13/12/2024 Medicine: Topotecan HospiraUpdated
13/12/2024 Medicine: Bamlanivimab and etesevimab for COVID-19Updated
13/12/2024 Medicine: EvusheldUpdated
13/12/2024 Medicine: RonapreveUpdated
13/12/2024 Medicine: RegkironaUpdated
13/12/2024 Page: Public-health advice on COVID-19 medicinesUpdated
13/12/2024 Page: Emergency Task Force (ETF) documentsUpdated
13/12/2024 Document: ETF statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants: December 2024 updateNew
13/12/2024 Post-authorisation: Bridion - opinion on variation to marketing authorisationNew
13/12/2024 Document: Procedural advice on paediatric applicationsUpdated
13/12/2024 News: First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndromeNew
13/12/2024 Medicine: StobocloNew
13/12/2024 Medicine: BeyonttraNew
13/12/2024 Medicine: AndembryNew
13/12/2024 Medicine: OsenveltNew
13/12/2024 Medicine: PaxneuryNew
13/12/2024 Medicine: ZefyltiNew
13/12/2024 Medicine: WeliregNew
13/12/2024 Medicine: EmcitateNew
13/12/2024 Medicine: AvtozmaNew
13/12/2024 Medicine: NemluvioNew
13/12/2024 Medicine: KavigaleNew
13/12/2024 Medicine: KostaiveNew
13/12/2024 Medicine: Seladelpar GileadNew
13/12/2024 Medicine: RyteloNew
13/12/2024 Medicine: EydenzeltNew
13/12/2024 Medicine: TuzulbyNew
13/12/2024 Post-authorisation: Omvoh - opinion on variation to marketing authorisationNew
13/12/2024 Post-authorisation: Ofev - opinion on variation to marketing authorisationNew
13/12/2024 Orphan: EU/3/20/2305 - orphan designation for treatment of myelodysplastic syndromesUpdated
13/12/2024 Orphan: EU/3/17/1945 - orphan designation for treatment of Allan-Herndon-Dudley syndromeUpdated
13/12/2024 Orphan: EU/3/17/1930 - orphan designation for treatment of primary biliary cholangitisUpdated
13/12/2024 Orphan: EU/3/21/2532 - orphan designation for treatment of hereditary angioedemaUpdated
13/12/2024 News: First medicine to treat rare genetic disorder causing cysts and tumours New
13/12/2024 News: Alofisel withdrawn from the EU marketNew
13/12/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024New
13/12/2024 Page: Big dataUpdated
13/12/2024 Medicine: LatudaUpdated
13/12/2024 News: First treatment recommended for rare progressive lung conditions in children and adolescentsNew
13/12/2024 Medicine: BeyfortusUpdated
13/12/2024 Medicine: NoxafilUpdated
12/12/2024 Medicine: RydaptUpdated
12/12/2024 Medicine: RelistorUpdated
12/12/2024 Medicine: SialanarUpdated
12/12/2024 Medicine: PedeaUpdated
12/12/2024 Medicine: ImjudoUpdated
12/12/2024 Medicine: LedagaUpdated
12/12/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - November 2024Updated
12/12/2024 Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements Updated
12/12/2024 Medicine: CystadropsUpdated
12/12/2024 Medicine: CystadaneUpdated
12/12/2024 Medicine: IsturisaUpdated
12/12/2024 Page: Investigation of bioequivalence - Scientific guidelineUpdated
12/12/2024 Page: Signal managementUpdated
11/12/2024 Document: CVMP work plan 2025New
11/12/2024 Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationUpdated
11/12/2024 Document: QRD veterinary Appendix I - Adverse event (PhV) MSs reporting detailsUpdated
11/12/2024 Page: EudraVigilance VeterinaryUpdated
11/12/2024 Document: Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)Updated
11/12/2024 Medicine: LytgobiUpdated
11/12/2024 Medicine: IbranceUpdated
11/12/2024 Medicine: GlivecUpdated
11/12/2024 Medicine: CystagonUpdated
11/12/2024 Medicine: EbvalloUpdated
11/12/2024 Medicine: TezspireUpdated
11/12/2024 DHPC: Kexxtone - direct healthcare professional communication (DHPC)Updated
11/12/2024 Medicine: YuflymaUpdated
11/12/2024 Medicine: QdengaUpdated
11/12/2024 Document: EMA communication perception survey report 2024New
11/12/2024 Medicine: TacforiusUpdated
11/12/2024 Medicine: HexyonUpdated
11/12/2024 Medicine: AltuvoctUpdated
11/12/2024 Medicine: RystiggoUpdated
11/12/2024 Medicine: ElahereUpdated
11/12/2024 Medicine: TeysunoUpdated
11/12/2024 Medicine: CorlentorUpdated
11/12/2024 Medicine: DectovaUpdated
11/12/2024 Medicine: CircadinUpdated
10/12/2024 Medicine: JulucaUpdated
10/12/2024 Medicine: AubagioUpdated
10/12/2024 Medicine: BraftoviUpdated
10/12/2024 Medicine: MektoviUpdated
10/12/2024 Medicine: TivicayUpdated
10/12/2024 Medicine: TriumeqUpdated
10/12/2024 Medicine: DovatoUpdated
10/12/2024 Page: Veterinary product information (QRD) templatesUpdated
10/12/2024 Event: 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA) Updated
10/12/2024 Document: European Shortages Monitoring Platform (ESMP): Stakeholder engagement planUpdated
10/12/2024 Document: Methodology European Specialised Expert Community (ESEC): MembersUpdated
10/12/2024 Document: Three-year rolling work plan for the Quality Innovation Group (QIG) 2025-2027New
10/12/2024 Document: Clinical trial information system (CTIS) public portal trial resultsUpdated
10/12/2024 Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questionsUpdated
10/12/2024 Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP)Updated
10/12/2024 Document: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.16Updated
10/12/2024 Document: Agenda - PDCO agenda of the 10-13 December 2024 meetingNew
10/12/2024 Event: Cancer Medicines Forum: October 2024New
10/12/2024 Document: QRD veterinary v.9.1 – Implementation planNew
10/12/2024 Document: QRD veterinary combined label-leaflet annotated template (English) v.9.1New
10/12/2024 Document: QRD veterinary product-information annotated template (English) version 9.1 highlightedNew
10/12/2024 Document: QRD veterinary product-information annotated template (English) version 9.1New
10/12/2024 Medicine: AquiptaUpdated
10/12/2024 Medicine: PraluentUpdated
10/12/2024 Event: 2024 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)Updated
10/12/2024 Medicine: OpuvizUpdated
10/12/2024 Document: Report from the 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA)New
09/12/2024 Medicine: MenQuadfiUpdated
09/12/2024 Document: European Medicines Agency mid-year report 2024 (January-June 2024)New
09/12/2024 Event: Thirteenth meeting of the industry stakeholder platform on research and development supportUpdated
09/12/2024 Event: 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilanceUpdated
09/12/2024 Document: Annual report of the Good Clinical Practice Inspectors Working Group 2023New
09/12/2024 DHPC: Cyanokit - direct healthcare professional communication (DHPC)New
09/12/2024 Document: Applications for new human medicines under evaluation: December 2024New
09/12/2024 Document: Letter of Support for intermediate Age-Related Macular Degeneration (AMD) biomarker and novel clinical endpoint developmentNew
09/12/2024 Document: Notification in preparation for the New fee regulation and new prepayment system for certificates of medicinal products, with implementation from January 2025New
09/12/2024 Page: Public information on medicine shortagesUpdated
09/12/2024 Page: Medicine shortages and availability issues: guidance for companiesUpdated
09/12/2024 Document: Guidance for industry on implementing shortage mitigation plans (SMP)New
09/12/2024 Document: Guidance for industry on implementing shortage prevention plans (SPP)New
09/12/2024 Page: Medicine shortage communications (MSC)New
09/12/2024 Document: Medicine shortage communication (MSC) templateNew
09/12/2024 Document: Agenda of the CHMP meeting 9-12 December 2024New
09/12/2024 Event: European Commission/EMA meeting with stakeholders on Translarna (ataluren)Updated
09/12/2024 Page: Signal management (veterinary medicines)Updated
09/12/2024 Medicine: YesafiliUpdated
06/12/2024 Event: Q&A clinic on post-authorisation procedure management in IRISNew
06/12/2024 Page: Quality of medicines questions and answers: Part 1Updated
06/12/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024New
06/12/2024 Medicine: Icthiovac ERMNew
06/12/2024 Medicine: Poulvac Procerta HVT-IBD-ND New
06/12/2024 Document: European Medicines Agency’s data protection notice regarding the experts database and the handling of competing interests of scientific committees’ members and expertsUpdated
06/12/2024 Medicine: LixianaUpdated
06/12/2024 Medicine: VotubiaUpdated
06/12/2024 Document: Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trialsNew
06/12/2024 Event: Q&A Clinic on post-authorisation procedure management in IRIS - 11 Dec 2024New
06/12/2024 Medicine: Bemrist BreezhalerUpdated
06/12/2024 Medicine: Atectura BreezhalerUpdated
06/12/2024 Referral: Finasteride- and dutasteride-containing medicinal products - referralUpdated
05/12/2024 Medicine: ScemblixUpdated
05/12/2024 Medicine: TafinlarUpdated
05/12/2024 DHPC: Ibandronic acid Accord - direct healthcare professional communication (DHPC)New
05/12/2024 Medicine: MekinistUpdated
05/12/2024 Medicine: Alli (previously Orlistat GSK)Updated
05/12/2024 Medicine: Vantavo (previously Alendronate sodium and colecalciferol, MSD)Updated
05/12/2024 Medicine: AdrovanceUpdated
05/12/2024 Medicine: EsperoctUpdated
05/12/2024 Medicine: PyzchivaUpdated
05/12/2024 Medicine: SpexotrasUpdated
05/12/2024 Medicine: BaqsimiUpdated
05/12/2024 Page: Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guidelineUpdated
05/12/2024 Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathiesUpdated
05/12/2024 Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2024Updated
05/12/2024 Medicine: Arsenic trioxide AccordUpdated
05/12/2024 Document: Guidance for applicants seeking scientific support and advice on traditional herbal medicinal productsUpdated
05/12/2024 Medicine: OvaleapUpdated
05/12/2024 Medicine: FosavanceUpdated
05/12/2024 Medicine: TheralugandUpdated
05/12/2024 Event: Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS)Updated
05/12/2024 Document: Three-year work plan for the Quality Drafting Group (QDG) of the Committee on Herbal Medicinal Products (HMPC)Updated
05/12/2024 Document: Data protection notice for the Experts Management Tool and the handling of competing interestsNew
05/12/2024 Medicine: Jcovden (previously COVID-19 Vaccine Janssen)Updated
05/12/2024 Document: Jcovden : Periodic safety update report assessment 25 February 2023 to 24 February 2024New
04/12/2024 Document: Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD)Updated
04/12/2024 Medicine: AdvateUpdated
04/12/2024 Medicine: KovaltryUpdated
04/12/2024 Page: How to payUpdated
04/12/2024 Document: How to pay fees and charges levied by EMA: Guidance to marketing authorisation holders and applicantsNew
04/12/2024 PSUSA: PSUSA/00000772/202404 - periodic safety update report single assessmentNew
04/12/2024 Document: Bimervax: Periodic safety update report assessment 30 March 2023 to 29 September 2023New
04/12/2024 Document: EVVet3 EVWeb Production - Release notesUpdated
04/12/2024 Document: Record of data processing activity relating to Security Access Control SystemUpdated
04/12/2024 Document: European Medicines Agency’s data protection notice for the operation of the Security Access Control SystemUpdated
04/12/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 5 December 2024New
04/12/2024 Page: Clinical requirements for non replacement therapy in haemophilia A and B - Scientific guidelineUpdated
04/12/2024 Document: Medicine shortage mitigation plan - templateUpdated
04/12/2024 Document: Medicine shortage prevention plan - templateUpdated
04/12/2024 Medicine: MenveoUpdated
04/12/2024 Medicine: ScintimunUpdated
04/12/2024 Document: Scintimun-H-C-PSUSA-00000385-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisationNew
03/12/2024 Medicine: Bevespi AerosphereUpdated
03/12/2024 Document: List of substances and products subject to worksharing for signal managementUpdated
03/12/2024 Medicine: TauvidUpdated
03/12/2024 Medicine: EnhertuUpdated
03/12/2024 Document: Pediatric Cluster Terms of ReferenceUpdated
03/12/2024 Medicine: CelsentriUpdated
03/12/2024 Medicine: XolairUpdated
03/12/2024 Medicine: CasgevyUpdated
03/12/2024 Medicine: TasignaUpdated
03/12/2024 Event: Translating innovation into access for ATMPs: third EU-Innovation network multi-stakeholder meetingUpdated
03/12/2024 Orphan: EU/3/23/2828 - orphan designation for treatment of transthyretin-mediated amyloidosisUpdated
03/12/2024 Medicine: Briviact (in Italy: Nubriveo)Updated
03/12/2024 Document: Briviact-H-C-PSUSA-00010447-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisationNew
03/12/2024 Event: EU NTC ten year anniversary eventUpdated
03/12/2024 Document: Report - EU NTC ten year anniversary eventNew
03/12/2024 Medicine: KimmtrakUpdated
03/12/2024 Page: Clinical evaluation of medicinal products used in weight control - Scientific guidelineUpdated
03/12/2024 Document: Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control New
03/12/2024 Event: Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 December 2024Updated
03/12/2024 Document: Agenda of the COMP meeting 3-5 December 2024New
03/12/2024 Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product informationUpdated
03/12/2024 Medicine: LumykrasUpdated
03/12/2024 Document: Lumykras : EPAR - Risk management planNew
03/12/2024 Document: Agenda of the CVMP meeting 3-5 December 2024New
03/12/2024 Document: Record of data processing activity for the Experts Management Tool and the handling of competing interestsUpdated
03/12/2024 Document: Expected publication dates of PRAC recommendations on safety signalsUpdated
03/12/2024 DHPC: Metamizole - direct healthcare professional communication (DHPC)New
03/12/2024 Orphan: EU/3/16/1752 - orphan designation for treatment of haemophilia AUpdated
02/12/2024 Medicine: Eribulin BaxterUpdated
02/12/2024 Medicine: TavlesseUpdated
02/12/2024 PSUSA: PSUSA/00002204/202404 - periodic safety update report single assessmentNew
02/12/2024 Medicine: NustendiUpdated
02/12/2024 Medicine: NilemdoUpdated
02/12/2024 Medicine: CabliviUpdated
02/12/2024 Medicine: Prevexxion RN+HVT+IBDUpdated
02/12/2024 Page: National competent authorities (human)Updated
02/12/2024 Medicine: MetacamUpdated
02/12/2024 Medicine: SancusoUpdated
02/12/2024 Medicine: Frontpro (previously Afoxolaner Merial)Updated
02/12/2024 Medicine: CerezymeUpdated
02/12/2024 Event: Committee for Advanced Therapies (CAT): 4-6 December 2024Updated
02/12/2024 Medicine: FabhaltaUpdated
02/12/2024 Document: Agenda of the CAT meeting 4-6 December 2024New
02/12/2024 Document: Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA’s regulatory activitiesUpdated
02/12/2024 Event: Paediatric Committee (PDCO): 15-18 October 2024Updated
02/12/2024 Document: Minutes - PDCO minutes of the 15-18 October 2024 meetingNew