What’s new
- PSUSA/00002550/202601
- Procedural timetables
- Minutes of the HMPC meeting 6-8 July 2026
- List of centrally authorised products with safety-related changes to the product information
- Policy 0072: Policy on the handling of information from external persons on breaches related to the authorisation, supervision and maintenance of human and veterinary medicinal products or other EMA activities
- Minutes of the CHMP meeting 15-18 September 2025
- Meeting summary - Medicine shortages SPOC working party meeting 15 July 2026
- Proceedings for the nomination and appointment of the next EMA Executive Director
- Minutes of PRAC meeting on 6-9 July 2026
- List of medicinal products under additional monitoring
- List of medicinal products under additional monitoring
- European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities
- European Shortages Monitoring Platform (ESMP) User guide for national competent authorities
- Certification procedures for advanced therapies under development by micro-, small- and medium-sized enterprises (SMEs)
- Agenda - Management Board meeting: 30 September 2026
News and press releases
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October
- Advice on ‘end-of-year’ submission dates for type I variations in 2026
- EMA Management Board: highlights of September 2026 meeting
- Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
- Executive Director speech at EMA women’s health multi-stakeholder workshop
- Women are missing from medicines development: EMA’s roadmap for change
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026
- New EU supply chain to end Visudyne shortage
- Voluntary data submission pilot to advance innovative alternatives to animal testing
- New leadership team appointments
- EMA appoints new Deputy Executive Director and new Head of Veterinary Medicines
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026
- EMA and EISMEA boost cooperation to accelerate health innovations
Human Medicines Highlights newsletter
- Human medicines highlights - April 2024
- Human medicines highlights - March 2024
- Human medicines highlights - February 2024
- Human medicines highlights - January 2024
- Human medicines highlights - November-December 2023
- Human medicines highlights - October 2023
- Human medicines highlights - September 2023
- Human medicines highlights - August 2023
- Human medicines highlights - August 2022
- Human medicines highlights - June 2022
- Human medicines highlights - May 2022
- Human medicines highlights - April 2022
- Human medicines highlights - March 2022
- Human medicines highlights - February 2022
- Human medicines highlights - January 2022
Events
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 15 July 2026, 09:30 (CEST) to 15 July 2026, 13:30 (CEST)
- European Medicines Agency workshop on bacteriophage therapy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 October 2026, 09:00 (CET) to 30 October 2026, 18:00 (CET)
- Seventeenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 November 2026, 09:00 (CET) to 20 November 2026, 13:00 (CET)
- ACT EU workshop on multiplicity in confirmatory clinical trials: From two-arm to platform trials , Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 27 November 2026, 09:00 (CET) to 27 November 2026, 15:00 (CET)
- Real-world data collection in Duchenne muscular dystrophy: Joint Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) multistakeholder workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 September 2026, 09:00 (CEST) to 25 September 2026, 17:30 (CEST)
- SME info day - navigating EMA support: From innovation to marketing authorisation, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 6 November 2026, 09:15 (CET) to 6 November 2026, 16:00 (CET)
- Sixth veterinary big data stakeholder forum, European Medicines Agency, Amsterdam, the Netherlands, from 10 November 2026, 09:00 (CET) to 10 November 2026, 17:30 (CET)
- Regulatory sandboxes: Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 September 2026, 13:30 (CEST) to 21 September 2026, 17:00 (CEST)
- EMA annual call with General Practitioner Organisations' representatives, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 November 2026, 13:00 (CET) to 20 November 2026, 15:00 (CET)
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 September 2026, 09:30 (CEST) to 15 September 2026, 13:30 (CEST)
- Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2026, European Medicines Agency, Amsterdam, the Netherlands, from 14 September 2026 to 17 September 2026
- First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 October 2026, 15:30 (CEST) to 5 October 2026, 17:30 (CEST)
- Fifth European Medicines Agency (EMA) - Vaccines Europe bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 October 2026, 14:00 (CET) to 26 October 2026, 16:00 (CET)
- EMA Biotech Hub and Technology Transfer Offices (TTOs) engagement workshop , Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 September 2026, 09:30 (CEST) to 16 September 2026, 16:30 (CEST)
- 2026 annual open meeting of the European Network of Paediatric Research at EMA (EnprEMA), Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 November 2026, 09:00 (CET) to 5 November 2026, 16:30 (CET)
Regulatory and procedural guidelines (human and veterinary)
- Member states contact points for review of national implementation of quick response (QR) codes of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures
- INS-GCP-1 procedure for coordinating good-clinical-practice inspections requested by the CHMP
- EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal
- Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
- Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - tracked changes
- Guidance for industry on implementing Shortage Prevention Plans (SPP)
- List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products
- Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.17
- Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.18
- Questions and answers on Article 20 non-pharmacovigilance procedures
- Questions and answers on Article 13 referral procedures
- Questions and answers on Article 29(4) referral procedures
- Questions and answers on Article 30 referral procedures
- Questions and answers on Article 31 non-pharmacovigilance referrals
- Pre-notification check for type IB Variations
Scientific guidelines (human and veterinary)
- ICH M13B guideline on bioequivalence for immediaterelease solid oral dosage forms - additional strengths biowaiver - Step 5
- ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5
- Questions and answers on post approval change management protocols for veterinary medicinal products
- Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of Module III on pharmacovigilance inspections
- Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1
- Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1
- Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum
- Concept paper on the development of a reflection paper on the use of External controls for evidence generation in regulatory decision-making
- Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
- Guideline on the plant testing strategy for veterinary medicinal products
- EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
- ICH M15 Guideline on general principles for model-informed drug development - Step 5
- Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes
- Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk
- Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
Agendas and Minutes
- Minutes of the HMPC meeting 6-8 July 2026
- Minutes of the CHMP meeting 15-18 September 2025
- Meeting summary - Medicine shortages SPOC working party meeting 15 July 2026
- Minutes of PRAC meeting on 6-9 July 2026
- Agenda - Management Board meeting: 30 September 2026
- Agenda of the PRAC meeting 28 September - 1 October 2026
- PDCO minutes of the 21-24 July 2026 meeting
- Minutes of the COMP meeting 14-15 July 2026
- Agenda of the HMPC meeting 22-24 September 2026
- Programme of the 2026 annual meeting of the European network of paediatric research at EMA (EnprEMA)
- Annex to agenda of the CHMP meeting 14-17 September 2026
- Agenda of the CHMP meeting 14-17 September 2026
- Agenda of the CAT meeting 9-11 September 2026
- Agenda of the CVMP meeting 8-10 September 2026
- Agenda - PDCO agenda of the 8-11 September 2026 meeting
European Union reference dates (EURD) list
- Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports
- List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Fees
- Fee Regulation wokring arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025 - Revision 2
- Fee Regulation wokring arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025 - Revision 1
- Fee Regulation wokring arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025
- 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
- Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal products
- Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use
- Fees payable to the European Medicines Agency: General questions and answers
- Presentation - Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders
- Presentation - Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders
- New fee regulation: General questions and answers - Annex IV
- New Fee Regulation: webinar on Regulation (EU) 2024/568 and changes foreseen for industry stakeholders (H)
- Decision of the Executive Director on fee incentives for scientific advice, marketing authorisation applications and pre-authorisation inspections in the ATMP support pilot for academia
- Fees payable to the European Medicines Agency
- Decision of the Executive Director on fee reductions for scientific advice requests for medicines for COVID-19 not covered by Article 16(2) of Regulation (EU) 2022/123
- Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2022
Herbal medicines for human use
- Herbal medicinal product: Prunus avium peduncleArray,Array, D: Draft under discussion
- Herbal medicinal product: Ricini oleum, Ricini oleum, F: Assessment finalised
- Herbal medicinal product: Rosae flos, Rosae flos, F: Assessment finalised
- Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised
- Call for scientific data for the periodic review of the monograph on Symphyti radix - Revision 1
- Call for scientific data for the periodic review of the monograph on Sisymbrii officinalis herba - Revision 1
- Call for scientific data for the periodic review of the monograph on Sideritis herba - Revision 1
- Herbal medicinal product: Sisymbrii officinalis herba, Sisymbrii officinalis herba, F: Assessment finalised
- Herbal medicinal product: Symphyti radix, Symphyti radix, F: Assessment finalised
- Herbal medicinal product: Sideritis herba, Sideritis herba, F: Assessment finalised
- Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
- Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
- Herbal medicinal product: Aloes folii succus siccatus, Aloes folii succus siccatus, F: Assessment finalised
- Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
- Herbal medicinal product: Urticae radix, Urticae radix, F: Assessment finalised
Human medicines: European public assessment reports (EPARs) and summaries of opinion
- Human medicines European public assessment report (EPAR): Yttriga, yttrium [90Y] chloride, Date of authorisation: 19/01/2006, Revision: 11, Status: Authorised
- Human medicines European public assessment report (EPAR): Tocilizumab STADA (previously Tofidence), tocilizumab, Date of authorisation: 20/06/2024, Revision: 4, Status: Authorised
- Summary of opinion: Hetlioz, 11/12/2025 Negative
- Human medicines European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals), pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted), Date of authorisation: 10/10/2009, Revision: 12, Status: Authorised
- Human medicines European public assessment report (EPAR): Cyanokit, hydroxocobalamin, Date of authorisation: 23/11/2007, Revision: 11, Status: Authorised
- Human medicines European public assessment report (EPAR): Lyvdelzi (previously Seladelpar Gilead), Seladelpar lysine dihydrate, Revision: 2, Status: Authorised
- Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), para-aminosalicylic acid, Date of authorisation: 07/04/2014, Revision: 13, Status: Authorised
- Human medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Dimethyl fumarate Teva, dimethyl fumarate, Date of authorisation: 12/12/2022, Date of refusal: 12/12/2023, Status: Withdrawn
- Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, Date of authorisation: 23/08/2018, Revision: 8, Status: Authorised
- Human medicines European public assessment report (EPAR): Gefzuris, gefapixant, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Lutholaz, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), pomalidomide, Date of authorisation: 05/08/2013, Revision: 24, Status: Authorised
Inspections
- Direct healthcare professional communication (DHPC) : Tavneos (avacopan) – recommendation for revocation of the marketing authorisation in the EU due to unfavourable benefit-risk balance
- QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics
- QRD Appendix V - Adverse-drug-reaction reporting details
- Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group
- Good Manufacturing Practice (GMP)/Distribution Practice Practice (GDP) Inspectors Working Group
- Good Clinical Practice Inspectors Working Group
- Quality systems framework for Good Manufacturing Practice (GMP) inspectorates
- Union format for a good manufacturing practice (GMP) certificate
- History of changes to the compilation of procedures
- Union format for registration of manufacturer, importer or distributor of active substance
- Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA
- Statement of non-compliance with good distribution practice of a distributor of active substances for use as starting materials in medicinal products
- Statement of non-compliance with good distribution practice
- Good distribution practice (GDP) inspection report – Union format
- Union format for a good distribution practice (GDP) certificate for active substances to be used as starting materials in medicinal products
Maximum residue limits and opinions on maximum residue limits
- Opinion of the CVMP on the establishment of maximum residue limits: Fluralaner ( EMEA/V/MRL/004380/EXTN/0002)
- Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)
- Ketoprofen: European public maximum-residue-limit assessment report (EPMAR) - CVMP
- Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide
- Rafoxanide (bovine and ovine milk): European Public MRL Assessment Report (EPMAR) - CVMP
- Opinion of the CVMP on the establishment of maximum residue limits: Ketoprofen
- Opinion of the CVMP on the establishment of maximum residue limits: Toltrazuril
- Toltrazuril (poultry eggs): European Public MRL Assessment Report (EPMAR) - CVMP
- Ketoprofen (poultry): European Public MRL Assessment Report (EPMAR) - CVMP
- Ketoprofen (all ruminants, porcine and Equidae) - Summary opinion of the CVMP on the extension of maximum residue limits
- Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - CVMP
- Lidocaine (porcine species): European Public MRL Assessment Report (EPMAR) - CVMP
- Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP
- Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
- Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
New medicines: human
- Human medicines European public assessment report (EPAR): Rhapsido, remibrutinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Blarcamesine Anavex, blarcamesine, Status: Opinion under re-examination
- Human medicines European public assessment report (EPAR): Anktiva, nogapendekin alfa inbakicept, Status: Opinion
- Human medicines European public assessment report (EPAR): Aumseqa, Aumolertinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Exdensur, depemokimab, Status: Opinion
- Human medicines European public assessment report (EPAR): Gotenfia, golimumab, Status: Opinion
- Human medicines European public assessment report (EPAR): mNexspike, COVID-19 mRNA vaccine, Status: Opinion
- Human medicines European public assessment report (EPAR): Ranluspec, ranibizumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Myqorzo, aficamten, Status: Opinion
- Summary of opinion: Metalyse, 14/12/2023 Positive
- Human medicines European public assessment report (EPAR): Skyclarys, Omaveloxolone, Status: Opinion
- Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion
- Human medicines European public assessment report (EPAR): Casgevy, Exagamglogene autotemcel, Status: Opinion
- Summary of opinion: Zinplava, 14/12/2023 Positive
- Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion
Orphan designations
- Orphan designation: daratumumab Treatment of AL amyloidosis, 25/05/2018 Withdrawn
- Orphan designation: satralizumab Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease, 22/06/2026 Positive
- Orphan designation: short hairpin RNA against NANOG mRNA Treatment of glioma, 23/06/2026 Positive
- Orphan designation: dasatinib Treatment of Diamond-Blackfan anaemia, 22/06/2026 Positive
- Orphan designation: humanised IgG4 monoclonal antibody against activated protein C Treatment of factor VII deficiency, 22/06/2026 Positive
- Orphan designation: human IgG1 monoclonal antibody against JC polyomavirus, major capsid protein VP1 Treatment of progressive multifocal leukoencephalopathy, 22/06/2026 Positive
- Orphan designation: (S)-Quinuclidin-3-yl((R)-5-(3-chloro-4-isopropoxyphenyl)-2,2-dimethyl-2,3-dihydro-1H-inden-1-yl)carbamate ((1S,4R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl)methanesulfonate Treatment of Gaucher disease, 22/06/2026 Positive
- Orphan designation: dinutuximab beta Treatment of Ewing sarcoma, 23/06/2026 Positive
- Orphan designation: 3-(Aminocarbonyl)-1-(2,3,5-tri-O-acetyl-beta-D-ribofuranosyl)-pyridinium chloride (1:1) Treatment of ataxia telangiectasia, 22/06/2026 Positive
- Orphan designation: cyclo(arginyl-glycyl-aspartyl-D-tyrosyl-lysyl)-nizaracianine-1 Treatment of head and neck cancer, 22/06/2026 Positive
- Orphan designation: (S)-N-(2-Methoxy-5-((5-(trifluoromethyl)pyridin-2-yl)oxy)phenyl)-3-methyl-2-oxoimidazolidine-4-carboxamide Treatment of malignant mesothelioma, 22/06/2026 Positive
- Orphan designation: guide RNA against the human HAO1 gene, mRNA encoding an engineered variant of the Cas12 nuclease Treatment of primary hyperoxaluria, 22/06/2026 Positive
- Orphan designation: adeno-associated viral vector serotype 8 containing the human CASQ2 gene Treatment of catecholaminergic polymorphic ventricular tachycardia, 22/06/2026 Positive
- Orphan designation: herpes simplex virus, type 1, containing the human NGF gene Treatment of neurotrophic keratitis, 22/06/2026 Positive
- Orphan designation: modified mRNA encoding human cystic fibrosis transmembrane conductance regulator Treatment of cystic fibrosis, 23/06/2026 Positive
Public consultations
- Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
- Draft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
- Draft guideline on user safety for pharmaceutical veterinary medicinal products - Revision 2
- Draft guideline on user safety of topically administered veterinary medicinal products - Revision 1
- Draft guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management - Revision 1
- Draft reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
- Concept paper on the revision of the CVMP guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1 Corr.1)
- Draft guideline on the investigation of interactions in the gastrointestinal tract
- Draft guideline on clinical investigation of medicinal products for the treatment of migraine and cluster headache - Revision 2
- Draft data standards framework
- Draft qualification opinion for the Big Multiple Sclerosis Data (BMSD) network
- Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases
- Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1
- Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
- Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)
Withdrawn applications
- Human medicines European public assessment report (EPAR): Zinmyleo, trilaciclib, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Isembyld, apitegromab, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Azacitidine Adienne, azacitidine, Status: Application withdrawn
- Withdrawn application: DuoResp Spiromax, 27/04/2026
- Withdrawn application: BiResp Spiromax, 27/04/2026
- Human medicines European public assessment report (EPAR): Viokat, diazoxide choline, Status: Application withdrawn
- Withdrawn application: Pluvicto, 23/04/2026
- Veterinary medicines European public assessment report (EPAR): Equidormin, midazolam, Status: Application withdrawn
- Veterinary medicines European public assessment report (EPAR): Cunitraxx, fenbendazole, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Zumrad, sasanlimab, Status: Application withdrawn
- Withdrawn application: Brilique, 15/12/2021
- Withdrawn application: Vectra 3D, 27/11/2024
- Human medicines European public assessment report (EPAR): Ohtuvayre, ensifentrine, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Insulin Aspart Injection, insulin aspart, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Datopotamab deruxtecan Daiichi Sankyo, datopotamab deruxtecan, Status: Application withdrawn
Paediatric investigation plans
- EMA/PE/0000302950
- EMA/PE/0000291645
- EMA/PE/0000261512
- Opinion/decision on a Paediatric investigation plan (PIP): Skyclarys, omaveloxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000338563
- EMA/PE/0000232482
- EMEA-002886-PIP03-24
- EMA/PE/0000235924
- EMA/PE/0000240621
- EMA/PE/0000241250
- EMA/PE/0000182809
- EMA/PE/0000232767
- EMEA-002828-PIP01-20
- EMEA-002004-PIP04-23
- EMA/PE/0000232778
- EMA/PE/0000232777