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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. This overview covers up to two months back. 

Results (412)

DateContentStatus
23/04/2025 Document: Report - Industry stakeholders and EU network experts surveys on early engagement fostering innovationUpdated
23/04/2025 Page: ProcurementUpdated
23/04/2025 Medicine: PyzchivaUpdated
23/04/2025 Medicine: TevimbraUpdated
23/04/2025 Medicine: Nilotinib AccordUpdated
23/04/2025 Medicine: Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)Updated
23/04/2025 Medicine: VimpatUpdated
23/04/2025 Medicine: NgenlaUpdated
23/04/2025 Medicine: TysabriUpdated
23/04/2025 Medicine: UzpruvoUpdated
23/04/2025 Medicine: MicardisUpdated
23/04/2025 Medicine: PritorUpdated
23/04/2025 Medicine: NoxafilUpdated
23/04/2025 Medicine: FlixabiUpdated
23/04/2025 Medicine: ZinplavaUpdated
23/04/2025 Medicine: EmendUpdated
23/04/2025 Medicine: Eltrombopag AccordUpdated
22/04/2025 Medicine: TemodalUpdated
22/04/2025 Medicine: IvemendUpdated
22/04/2025 Document: Article 57 product dataUpdated
22/04/2025 Medicine: KuvanUpdated
22/04/2025 Medicine: ScemblixUpdated
22/04/2025 Medicine: ZegalogueUpdated
22/04/2025 Document: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)Updated
22/04/2025 Page: Policies and proceduresUpdated
22/04/2025 Medicine: KisplyxUpdated
22/04/2025 Medicine: LenvimaUpdated
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 coordinationNew
22/04/2025 Document: Business process description for translations New
22/04/2025 Document: Business process description for scientific adviceNew
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 managementNew
22/04/2025 Document: Business process description for certificates of medicinal productsNew
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: EvraUpdated
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 scientific meeting 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 processesNew
22/04/2025 Document: Business process description for regulatory and scientific guidelinesNew
22/04/2025 Document: Business process description for expert managementNew
22/04/2025 Document: Business process description for committee management New
22/04/2025 Document: Template for late submission of ICSRs to EVUpdated
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 trialsUpdated
22/04/2025 Page: Electronic product information (ePI)Updated
22/04/2025 Medicine: Spikevax (previously COVID-19 Vaccine Moderna)Updated
22/04/2025 Medicine: RetacritUpdated
16/04/2025 PSUSA: PSUSA/00002774/202408 - periodic safety update report single assessmentNew
16/04/2025 PSUSA: PSUSA/00000027/202407 - periodic safety update report single assessmentNew
16/04/2025 Medicine: DyrupegUpdated
16/04/2025 Medicine: ZerbaxaUpdated
16/04/2025 Medicine: PlavixUpdated
16/04/2025 Medicine: Pirfenidone ViatrisUpdated
16/04/2025 Page: Variations requiring assessment (veterinary medicines)Updated
16/04/2025 Medicine: EpysqliUpdated
16/04/2025 Medicine: IscoverUpdated
16/04/2025 Medicine: ElapraseUpdated
16/04/2025 Page: Medicine evaluation figuresUpdated
16/04/2025 Medicine: PrevymisUpdated
16/04/2025 Document: EMA Agile governance modelUpdated
16/04/2025 Document: Medicinal products for human use: monthly figures - March 2025New
16/04/2025 Medicine: CometriqUpdated
16/04/2025 Page: ICH M15 guideline on general principles for model-informed drug development - Step 2b - Scientific guidelineUpdated
16/04/2025 Medicine: VyvgartUpdated
16/04/2025 Page: Medicines for human use under evaluationUpdated
16/04/2025 Document: European Medicines Agency’s Data Protection Notice for the operation of video-surveillance (CCTV) systemUpdated
16/04/2025 Document: Record of data processing activity for video-surveillance (CCTV) systemUpdated
16/04/2025 Event: Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 March 2025Updated
16/04/2025 Medicine: KeytrudaUpdated
16/04/2025 Document: Minutes of the CVMP meeting 11-13 March 2025New
16/04/2025 Medicine: CabometyxUpdated
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 originUpdated
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 guidelineNew
15/04/2025 PSUSA: PSUSA/00002920/202408 - periodic safety update report single assessmentNew
15/04/2025 Medicine: ZefyltiUpdated
15/04/2025 Medicine: TamifluUpdated
15/04/2025 Medicine: InovelonUpdated
15/04/2025 Medicine: FlucelvaxUpdated
15/04/2025 Page: Fees payable to the European Medicines AgencyUpdated
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 devicesNew
15/04/2025 Page: Fees payable to the European Medicines Agency: Annual fees and remunerationNew
15/04/2025 Page: Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal productsNew
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 useNew
15/04/2025 Page: Fees payable to the European Medicines Agency: General questions and answersNew
15/04/2025 Document: Pool of healthcare professional experts: list for 2024-2029New
15/04/2025 Document: Pool of patient and consumer experts: list for 2024-2029New
15/04/2025 Medicine: MounjaroUpdated
15/04/2025 Medicine: ValdoxanUpdated
15/04/2025 Medicine: Omeprazole TriviumVetUpdated
15/04/2025 Medicine: ElmaroUpdated
15/04/2025 Medicine: Vectormune HVT-AIVUpdated
15/04/2025 Medicine: MirceraUpdated
15/04/2025 Medicine: OpdivoUpdated
15/04/2025 News: EMA business hours over Easter holiday periodNew
15/04/2025 Herbal: Allii sativi bulbus - herbal medicinal productUpdated
15/04/2025 Herbal: Arnicae flos - herbal medicinal productUpdated
15/04/2025 Herbal: Crataegi folium cum flore - herbal medicinal productUpdated
15/04/2025 Page: Procedures for monograph and list entry establishmentUpdated
15/04/2025 Herbal: Combination: Valerianae radix and Passiflorae herba - herbal medicinal productUpdated
15/04/2025 Document: Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herbaNew
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: AbrysvoUpdated
15/04/2025 Medicine: Clopidogrel Viatris (previously Clopidogrel Taw Pharma)Updated
15/04/2025 Document: Policy 26: Records management and archives policyUpdated
15/04/2025 Document: Procedural advice on paediatric applicationsUpdated
15/04/2025 Medicine: PrometaxUpdated
15/04/2025 Page: Non-clinical Working PartyUpdated
15/04/2025 Event: EMA’s 30th anniversary scientific conference - Medicines, regulation and the futureUpdated
15/04/2025 Page: Nitrosamines Safety Operational Expert GroupUpdated
15/04/2025 PSUSA: PSUSA/00000464/202407 - periodic safety update report single assessmentNew
14/04/2025 Medicine: CapvaxiveUpdated
14/04/2025 Medicine: Lyvdelzi (previously Seladelpar Gilead)Updated
14/04/2025 Shortage: DynastatNew
14/04/2025 Document: Agenda of the CAT meeting 14-16 April 2025New
14/04/2025 Medicine: StelaraUpdated
14/04/2025 Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meetingUpdated
14/04/2025 Page: Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guidelineUpdated
14/04/2025 Document: Minimum inhibitory concentration (MIC) breakpointsUpdated
14/04/2025 Medicine: RezolstaUpdated
14/04/2025 Medicine: RinvoqUpdated
14/04/2025 PIP: EMEA-001270-PIP01-12-M07 - paediatric investigation planUpdated
14/04/2025 PIP: EMEA-001314-PIP01-12-M02 - paediatric investigation planUpdated
14/04/2025 Page: Product-information (QRD) templates - HumanUpdated
14/04/2025 Document: Quality Review of Documents (QRD) annotated template v11: Draft for public consultationNew
14/04/2025 Document: Quality Review of Documents (QRD) annotated template v11: Form for submission of comments to public consultationNew
14/04/2025 Document: Key information section in package leaflet of centrally authorised medicinal products: Public consultationNew
14/04/2025 Document: Quality Review of Documents (QRD) annotated template v11: Draft for public consultation - track changesNew
14/04/2025 PIP: EMEA-001539-PIP01-13-M06 - paediatric investigation planUpdated
14/04/2025 PIP: EMEA-001579-PIP01-13-M06 - paediatric investigation planUpdated
14/04/2025 PIP: EMEA-002741-PIP01-20-M02 - paediatric investigation planUpdated
14/04/2025 PIP: EMEA-002338-PIP04-23 - paediatric investigation planNew
14/04/2025 Page: Eligible patients and consumers organisationsUpdated
14/04/2025 PIP: EMEA-002915-PIP01-20-M03 - paediatric investigation planUpdated
14/04/2025 Medicine: EliquisUpdated
14/04/2025 PIP: EMEA-003420-PIP01-23 - paediatric investigation planNew
14/04/2025 News: Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EUNew
14/04/2025 Page: Availability of medicines before and during crisesUpdated
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 radiopharmaceuticalsNew
14/04/2025 Medicine: SkojoyUpdated
14/04/2025 Medicine: TrumenbaUpdated
14/04/2025 Medicine: Sugammadex PiramalUpdated
14/04/2025 Medicine: VyduraUpdated
14/04/2025 PIP: EMEA-003423-PIP02-23 - paediatric investigation planNew
14/04/2025 Document: PhV non-compliance notification contact points at National Competent Authority (NCA) levelUpdated
14/04/2025 Page: Contacts at the European Medicines AgencyUpdated
14/04/2025 Document: CHMP-CAT - D80-210 Overview to final EPAR - Rev 04.25 (Revamp)New
11/04/2025 Medicine: HerzumaUpdated
11/04/2025 Medicine: ExelonUpdated
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: CinqaeroUpdated
11/04/2025 Medicine: EdurantUpdated
11/04/2025 Medicine: EffentoraUpdated
11/04/2025 Medicine: FabhaltaUpdated
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 guidelineUpdated
11/04/2025 Page: Medical devicesUpdated
11/04/2025 Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodiesUpdated
11/04/2025 Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changesNew
11/04/2025 Medicine: EntyvioUpdated
11/04/2025 Document: Overview of NCAs participating in the voluntary Simultaneous National Scientific Advice (SNSA) projectUpdated
11/04/2025 Page: COVID-19 vaccines: key factsUpdated
11/04/2025 EU-M4all: Aluvia - opinion on medicine for use outside EUUpdated
11/04/2025 Page: Clinical investigation of medicinal products in the treatment of depression - Scientific guidelineUpdated
11/04/2025 Medicine: XermeloUpdated
11/04/2025 Medicine: EmevetNew
11/04/2025 Medicine: Nobilis Multriva Gm+REOmNew
11/04/2025 Medicine: Nobilis Multriva IBm+NDNew
11/04/2025 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025New
11/04/2025 PSUSA: PSUSA/00000742/202408 - periodic safety update report single assessmentNew
11/04/2025 PSUSA: PSUSA/00000986/202409 - periodic safety update report single assessmentNew
11/04/2025 Medicine: KisunlaUpdated
11/04/2025 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025New
11/04/2025 Page: Assessment templates and guidanceUpdated
11/04/2025 Medicine: Fingolimod AccordUpdated
11/04/2025 Medicine: SialanarUpdated
11/04/2025 Medicine: OrphacolUpdated
11/04/2025 Page: Emergency Task Force (ETF)Updated
11/04/2025 Document: Composition of the Emergency Task Force (ETF) for preparednessNew
11/04/2025 Document: Superseded - Composition of the Emergency Task Force (ETF) for preparednessUpdated
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: RevestiveUpdated
11/04/2025 Medicine: MoventigUpdated
11/04/2025 Medicine: BreyanziUpdated
10/04/2025 PSUSA: PSUSA/00010856/202408 - periodic safety update report single assessmentNew
10/04/2025 Medicine: AkynzeoUpdated
10/04/2025 Medicine: AvonexUpdated
10/04/2025 Document: QRD veterinary Appendix I - Adverse event (PhV) MSs reporting detailsUpdated
10/04/2025 Medicine: TrepulmixUpdated
10/04/2025 Medicine: EbglyssUpdated
10/04/2025 Medicine: KaftrioUpdated
10/04/2025 Medicine: DarzalexUpdated
10/04/2025 Medicine: Supemtek Tetra (previously Supemtek)Updated
10/04/2025 Event: 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work planUpdated
10/04/2025 Shortage: ZirabevUpdated
10/04/2025 Document: Innovation Task Force (ITF) briefing meeting request formUpdated
10/04/2025 Medicine: Relvar ElliptaUpdated
10/04/2025 Medicine: KayfandaUpdated
10/04/2025 Medicine: BylvayUpdated
10/04/2025 Medicine: KaletraUpdated
10/04/2025 Document: Minutes - PDCO minutes of the 25-28 February 2025 meetingNew
10/04/2025 Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-19 March 2025New
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 expertsUpdated
10/04/2025 Medicine: PavbluUpdated
10/04/2025 Document: Electronic submission of Article 57(2) data: questions and answersUpdated
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 EMAUpdated
10/04/2025 Document: List of industry subject matter experts and list of planned calls for industry subject matter expertsUpdated
09/04/2025 Document: QRD Appendix V - Adverse-drug-reaction reporting detailsUpdated
09/04/2025 Medicine: EsbrietUpdated
09/04/2025 Medicine: RonapreveUpdated
09/04/2025 Medicine: HulioUpdated
09/04/2025 Document: Minutes of the PRAC meeting 10-13 February 2025New
09/04/2025 Medicine: BavencioUpdated
09/04/2025 Medicine: CompetactUpdated
09/04/2025 Page: PRIME: priority medicinesUpdated
09/04/2025 News: EU recommendations for 2025/2026 seasonal flu vaccine compositionUpdated
09/04/2025 Document: List of medicines currently in PRIME schemeUpdated
09/04/2025 Document: Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026Updated
09/04/2025 Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 24-27 March 2025New
09/04/2025 Medicine: VyloyUpdated
09/04/2025 Medicine: BesremiUpdated
09/04/2025 Medicine: Talmanco (previously Tadalafil Generics)Updated
09/04/2025 Medicine: FinteplaUpdated
09/04/2025 Medicine: IxchiqUpdated
09/04/2025 Document: Minutes of the PRAC meeting 28-31 October 2024Updated
09/04/2025 Document: Minutes of the PRAC meeting 25-28 November 2024Updated
09/04/2025 Document: Minutes of the PRAC meeting 2-5 September 2024Updated
09/04/2025 Document: Minutes of the PRAC meeting 13-16 May 2024Updated
09/04/2025 Medicine: QuinsairUpdated
09/04/2025 Medicine: Rasagiline ratiopharmUpdated
09/04/2025 Orphan: EU/3/20/2305 - orphan designation for treatment of myelodysplastic syndromesUpdated
09/04/2025 Page: Emergency Task Force (ETF) documentsUpdated
09/04/2025 Document: ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2bNew
09/04/2025 Page: ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guidelineNew
09/04/2025 Orphan: EU/3/21/2550 - orphan designation for treatment of soft tissue sarcomaUpdated
09/04/2025 Orphan: EU/3/19/2232 - orphan designation for treatment of amyotrophic lateral sclerosisUpdated
09/04/2025 Orphan: EU/3/24/2902 - orphan designation for treatment of mesotheliomaUpdated
09/04/2025 Orphan: EU/3/21/2497 - orphan designation for treatment of diffuse large B-cell lymphomaUpdated
08/04/2025 Medicine: LoqtorziUpdated
08/04/2025 Medicine: Kentera (previously Oxybutynin Nicobrand)Updated
08/04/2025 Medicine: AzilectUpdated
08/04/2025 Event: EMA roundtable with stakeholders on the 20th anniversary of the SME RegulationNew
08/04/2025 Medicine: Pregabalin Viatris Pharma (previously Pregabalin Pfizer)Updated
08/04/2025 Page: Real-world evidenceUpdated
08/04/2025 Medicine: RefixiaUpdated
08/04/2025 Medicine: Sugammadex AdroiqUpdated
08/04/2025 Medicine: EnspryngUpdated
08/04/2025 Medicine: Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)Updated
08/04/2025 Medicine: OntozryUpdated
08/04/2025 Medicine: EvrenzoUpdated
08/04/2025 Medicine: Azacitidine MylanUpdated
08/04/2025 Medicine: LysodrenUpdated
08/04/2025 Page: Animal health practitionersNew
08/04/2025 Document: Agenda of the CVMP meeting 8-10 April 2025New
08/04/2025 Document: Veterinary medicines safety day: How to report adverse events - simple guideNew
08/04/2025 Document: Veterinary medicines safety day: Adverse event reporting in the EU - presentationNew
08/04/2025 Document: Veterinary medicines safety day: Social media infocardsNew
08/04/2025 Event: SPOR and XEVMPD status update webinarUpdated
08/04/2025 Page: Guidance on good manufacturing practice and good distribution practice: Questions and answersUpdated
08/04/2025 Event: Twelfth Industry Standing Group (ISG) meetingUpdated
08/04/2025 Event: Clinical Trials Information System (CTIS): Information dayUpdated
08/04/2025 Event: Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicinesUpdated
07/04/2025 Medicine: AvtozmaUpdated
07/04/2025 Medicine: MvabeaUpdated
07/04/2025 Medicine: TaltzUpdated
07/04/2025 Medicine: FluenzUpdated
07/04/2025 Event: Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 April 2025Updated
07/04/2025 Medicine: ZabdenoUpdated
07/04/2025 Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 March 2025 PRACNew
07/04/2025 Document: List of signals discussed at PRAC since September 2012Updated
07/04/2025 Document: PRAC recommendations on signals adopted at the 10-13 March 2025 meetingNew
07/04/2025 Page: Medicine shortage communications (MSC)Updated
07/04/2025 Document: Medicine shortage communication (MSC): Mimpara (cinacalcet)New
07/04/2025 Shortage: MimparaNew
07/04/2025 Medicine: ElrexfioUpdated
07/04/2025 Medicine: TivdakUpdated
07/04/2025 Orphan: EU/3/25/3039 - orphan designation for treatment of haemophilia BNew
07/04/2025 Orphan: EU/3/25/3043 - orphan designation for treatment of primary IgA nephropathyNew
07/04/2025 Orphan: EU/3/25/3042 - orphan designation for treatment of Rett syndromeNew
07/04/2025 Orphan: EU/3/25/3041 - orphan designation for treatment of Marfan syndromeNew
07/04/2025 Orphan: EU/3/25/3038 - orphan designation for treatment of haemophilia BNew
04/04/2025 Event: Thirteenth meeting of the industry stakeholder platform on research and development supportUpdated
04/04/2025 Document: Highlight report - 13th Industry stakeholder platform on research and development supportNew
04/04/2025 Document: SMS guidance for external usersUpdated
04/04/2025 PSUSA: PSUSA/00002942/202406 - periodic safety update report single assessmentNew
04/04/2025 Medicine: RoclandaUpdated
04/04/2025 Medicine: AjovyUpdated
04/04/2025 Medicine: OpsumitUpdated
04/04/2025 Medicine: SomaKit TOCUpdated
04/04/2025 Medicine: StobocloUpdated
04/04/2025 Medicine: Rivastigmine SandozUpdated
04/04/2025 Medicine: Rivastigmine HexalUpdated
04/04/2025 Medicine: Rivastigmine 1 A PharmaUpdated
04/04/2025 Orphan: EU/3/25/3044 - orphan designation for treatment of myelodysplastic syndromesNew
04/04/2025 Medicine: Sitagliptin / Metformin hydrochloride MylanUpdated
04/04/2025 Orphan: EU/3/25/3037 - orphan designation for treatment of non-traumatic spontaneous intracerebral haemorrhageNew
04/04/2025 Medicine: RxultiUpdated
04/04/2025 Orphan: EU/3/20/2277 - orphan designation for treatment of multiple myelomaUpdated
04/04/2025 Orphan: EU/3/24/3002 - orphan designation for treatment of in solid organ transplantationUpdated
04/04/2025 Orphan: EU/3/25/3040 - orphan designation for treatment of bradykinin-mediated angioedemaNew
04/04/2025 Medicine: ReblozylUpdated
04/04/2025 Document: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changesUpdated
04/04/2025 Medicine: Vildagliptin / Metformin hydrochloride AccordUpdated
03/04/2025 Medicine: CejemlyUpdated
03/04/2025 Medicine: LutatheraUpdated
03/04/2025 Medicine: PerjetaUpdated
03/04/2025 Medicine: RoActemraUpdated
03/04/2025 Medicine: MabTheraUpdated
03/04/2025 Document: Antimicrobial Sales and Use (ASU) Platform: Release notesUpdated
03/04/2025 Medicine: JinarcUpdated
03/04/2025 Medicine: Seffalair SpiromaxUpdated
03/04/2025 Medicine: ellaOneUpdated
03/04/2025 Medicine: CamceviUpdated
03/04/2025 Medicine: TukysaUpdated
03/04/2025 Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposesNew
03/04/2025 Document: Journey towards a roadmap for regulatory guidance on real-world evidenceNew
03/04/2025 Medicine: LitakUpdated
03/04/2025 Medicine: YondelisUpdated
03/04/2025 Medicine: HetroniflyUpdated
03/04/2025 Medicine: OsenveltUpdated
03/04/2025 Medicine: Eptifibatide AccordUpdated
03/04/2025 Medicine: RystiggoUpdated
03/04/2025 Medicine: CopiktraUpdated
03/04/2025 Page: Scientific and technical recommendations: Veterinary Medicines RegulationUpdated
03/04/2025 News: Clinical Trials Information System designated as WHO primary registryNew
02/04/2025 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
02/04/2025 Medicine: ExtaviaUpdated
02/04/2025 Medicine: JardianceUpdated
02/04/2025 PIP: EMEA-002656-PIP01-19-M01 - paediatric investigation planUpdated
02/04/2025 PIP: EMEA-002565-PIP02-19-M01 - paediatric investigation planUpdated
02/04/2025 Medicine: SynjardyUpdated
02/04/2025 Medicine: PelmegUpdated
02/04/2025 Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)Updated
02/04/2025 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
02/04/2025 Document: Joint HTAb-regulatory perspectives on understanding evidence challenges, managing uncertainties and exploring potential solutionsNew
02/04/2025 Medicine: BroPair SpiromaxUpdated
02/04/2025 Page: Biosimilar medicines: OverviewUpdated
02/04/2025 Page: Tolvaptan product-specific bioequivalence guidanceNew
02/04/2025 PIP: EMEA-000551-PIP04-21-M03 - paediatric investigation planUpdated
02/04/2025 PIP: EMEA-002121-PIP03-19-M02 - paediatric investigation planUpdated
02/04/2025 PIP: EMEA-000237-PIP01-08-M12 - paediatric investigation planUpdated
02/04/2025 PIP: EMEA-002234-PIP01-17-M02 - paediatric investigation planUpdated
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 GroupUpdated
01/04/2025 Page: Data in regulation: Big data and other sourcesUpdated
01/04/2025 PIP: EMEA-003523-PIP01-23 - paediatric investigation planNew
01/04/2025 Page: Plasma master file certificatesUpdated
01/04/2025 Medicine: Bortezomib AccordUpdated
01/04/2025 Medicine: SlenytoUpdated
01/04/2025 PIP: EMEA-003515-PIP01-23 - paediatric investigation planNew
01/04/2025 PIP: EMEA-003299-PIP02-22 - paediatric investigation planNew
01/04/2025 PIP: EMEA-003522-PIP01-23 - paediatric investigation planNew
01/04/2025 PIP: EMEA-002205-PIP02-23 - paediatric investigation planNew
01/04/2025 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025Updated
01/04/2025 Medicine: GlyxambiUpdated
01/04/2025 Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationUpdated
01/04/2025 Medicine: ZubsolvUpdated
01/04/2025 Document: Day 80 assessment report - Non-clinical template with guidance Rev. 03.25 - Revamp Updated
01/04/2025 News: Streamlining development and assessment of biosimilar medicinesNew
01/04/2025 Document: Reflection paper on a tailored clinical approach in biosimilar developmentNew
01/04/2025 Medicine: EvistaUpdated
01/04/2025 Shortage: RoActemraUpdated
01/04/2025 Document: IRIS guide to registration and RPIsUpdated
01/04/2025 Document: Organisation chart: Veterinary MedicinesUpdated
01/04/2025 Document: Minutes of the CAT meeting 19-21 February 2025New
01/04/2025 Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR APIUpdated
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 MAHUpdated
01/04/2025 Event: SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for SponsorsUpdated
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 GovernanceUpdated
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 2024-10Updated
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 PanelsUpdated
01/04/2025 PIP: EMEA-003516-PIP01-23 - paediatric investigation planNew
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 2025New
01/04/2025 Page: Handling competing interestsUpdated
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 ToolUpdated
01/04/2025 Medicine: DupixentUpdated
01/04/2025 Event: Management Board meeting: 13 March 2025Updated
01/04/2025 Event: ICMRA Summit 2025New
01/04/2025 Herbal: Salicis cortex - herbal medicinal productUpdated
01/04/2025 Herbal: Psyllii semen - herbal medicinal productUpdated
01/04/2025 Herbal: Harpagophyti radix - herbal medicinal productUpdated
01/04/2025 Herbal: Hamamelidis cortex - herbal medicinal productUpdated
01/04/2025 Herbal: Hamamelidis folium - herbal medicinal productUpdated
01/04/2025 Herbal: Equiseti herba - herbal medicinal productUpdated
01/04/2025 Herbal: Hamamelidis folium et cortex aut ramunculus destillatum - herbal medicinal productUpdated
01/04/2025 Herbal: Combination: Valerianae radix and Lupuli flos - herbal medicinal productUpdated
01/04/2025 Herbal: Carvi fructus - herbal medicinal productUpdated
01/04/2025 Herbal: Carvi aetheroleum - herbal medicinal productUpdated
01/04/2025 Herbal: Althaeae radix - herbal medicinal productUpdated
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Valerianae radix and Lupuli flosNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Salicis cortexNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Psyllii semenNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Harpagophyti radixNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Hamamelidis folium et cortex aut ramunculus destillatumNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Hamamelidis foliumNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Hamamelidis cortexNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Equiseti herbaNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Carvi fructusNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Carvi aetheroleumNew
01/04/2025 Document: Call for scientific data for the periodic review of the monograph on Althaeae radixNew
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