What’s new
- Veterinary medicines European public assessment report (EPAR): Oncept IL-2, feline interleukin-2 recombinant canarypox virus (vCP1338 virus), Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Nobilis IB Primo QX, avian infectious bronchitis virus strain D388, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Nobivac Bb, live vaccine against Bordetella bronchiseptica in cats, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli), vaccine to provide passive immunity to the progeny against E. coli in pigs, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Porcilis AR-T DF, adjuvanted vaccine against progressive atrophic rhinitis in piglets, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Melosus, meloxicam, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Meloxidyl, meloxicam, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Pexion, imepitoin, Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Masivet, masitinib mesilate, Status: Authorised
- Nasym : EPAR - Public Assessment report
- Veterinary medicines European public assessment report (EPAR): Nasym, bovine respiratory syncytial virus vaccine (live), Status: Authorised
- Veterinary medicines European public assessment report (EPAR): MS-H Vaccine, Mycoplasma synoviae (live), Status: Authorised
- Veterinary medicines European public assessment report (EPAR): Mirataz, mirtazapine, Status: Authorised
- Annual report of the Pharmacovigilance Inspectors Working Group for 2024
- Veterinary medicines European public assessment report (EPAR): OvuGel, triptorelin, Status: Authorised
News and press releases
- EMA Management Board: highlights of October 2025 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025
- Advice on end of year submission dates for type I variations in 2025
- A path to better include patients’ perspectives in the regulation of medicines
- New targets for clinical trials in Europe
- Use of paracetamol during pregnancy unchanged in the EU
- New variations guidelines to streamline lifecycle management of medicines
- First treatment recommended for rare immunoglobulin-related autoimmune disease
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 9-10 September 2025
- Management Board formally approves renewal of Executive Director’s mandate
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1 – 4 September 2025
- Warning about sharp rise in illegal medicines sold in the EU
- EMA and WHO mark ten years of collaboration to advance global access to medicines
- EMA closed on 15 August for Assumption Day
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
- EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 November 2025, 09:00 (CET) to 25 November 2025, 16:00 (CET)
- European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 18 November 2025 to 19 November 2025
- ACT EU multi-stakeholder platform annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 October 2025, 09:30 (CET) to 29 October 2025, 17:00 (CET)
- Enpr-EMA Coordinating Group and networks meeting June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, 11 June 2025
- Industry stakeholder webinar on revised environmental risk assessment guideline for medicinal products for human use - 1 year experience, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 14:30 (CEST) to 6 October 2025, 17:00 (CEST)
- First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection, European Medicines Agency, Amsterdam, the Netherlands, 5 November 2025
- Cancer Medicines Forum: June 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 17 June 2025, 14:00 (CEST) to 17 June 2025, 17:00 (CEST)
- First European Medicines Agency (EMA) and Association of Clinical Research Organizations (ACRO) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025
- LinkedIn Live: Smarter trials, stronger Europe. New targets for clinical research., European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2025, 14:00 (CEST) to 24 September 2025, 15:00 (CEST)
- Committee for Medicinal Products for Human Use (CHMP): 15-18 September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 15 September 2025 to 18 September 2025
- European Medicines Agency (EMA) and European Association of Urology (EAU) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 10 October 2025
- First EMA and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)
- First European Medicines Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 September 2025, 10:30 (CEST) to 26 September 2025, 12:00 (CEST)
- Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 10 September 2025, 09:30 (CEST) to 10 September 2025, 13:00 (CEST)
- Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting September 2025, European Medicines Agency, Amsterdam, the Netherlands, from 24 September 2025, 09:00 (CEST) to 24 September 2025, 16:10 (CEST)
Regulatory and procedural guidelines (human and veterinary)
- Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782
- Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer
- PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment
- EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 6: Examples for submission of legacy data (obsolete)
- EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (obsolete)
- Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance
- Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance
- Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)
- QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures
- Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.17
- 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 for 2025
- 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.16
- User guide of the HMA-EMA Catalogues of real-world data sources and studies
- Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025
- Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.5
Scientific guidelines (human and veterinary)
- Guideline on in-use stability testing of veterinary medicinal products
- Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks
- Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
- Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Revision 2
- Guideline on the pharmaceutical quality of inhalation and nasal medicinal products - Revision 1
- Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1
- Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
- Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
- Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials
- Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations
- Implementation strategy of ICH Guideline M12 on drug interaction studies
- Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
- Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
- ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 5
- Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater
Agendas and Minutes
- Minutes of the CHMP written procedure 18-21 August 2025
- Agenda of the CAT meeting 8-9 October 2025
- HMA-EMA joint Network Data Steering Group meeting - 16 September 2025
- Agenda - Instrument for Pre-accession Assistance (IPA) training on assessing medicinal products in the EU: A practical introduction
- Agenda of the CVMP meeting 7-9 October 2025
- Agenda of the COMP meeting 7-8 October 2025
- Minutes - Enpr-EMA Coordinating Group & networks meeting - June 2025
- Agenda - Management Board meeting: 2 October 2025
- Minutes of the CAT meeting 12-14 August 2025 - written procedure
- Minutes of the CAT meeting 16-18 July 2025
- Agenda of the PRAC meeting 29 September - 2 October 2025
- Minutes of the HMPC meeting 7-9 July 2025
- HMA-EMA joint Network Data Steering Group meeting - 17 July 2025
- Minutes of the COMP meeting 15-17 July 2025
- Minutes - PDCO minutes of the 22-25 July 2025 meeting
European Union reference dates (EURD) list
- 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
- 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
- Fees payable to the European Medicines Agency
- Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
- How to pay
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): 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
- Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif), human normal immunoglobulin, Date of authorisation: 23/07/2007, Revision: 19, Status: Authorised
- Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Psoriasis, Date of authorisation: 24/03/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Ammonaps, sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosphate Synthase I Deficiency Disease, Date of authorisation: 07/12/1999, Revision: 21, Status: Authorised
- Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests;Helicobacter Infections, Date of authorisation: 14/08/1997, Revision: 18, Status: Authorised
- Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, Date of authorisation: 30/05/2017, Revision: 6, Status: Authorised
Inspections
- 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
- Union format for a wholesale distribution authorisation
- Notification of serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations
- Statement of non-compliance with good manufacturing practice (GMP)
- Union format for a good distribution practice (GDP) certificate
Maximum residue limits and opinions on maximum residue limits
- 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)
- Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel
- Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel
New medicines: human
- 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
- Human medicines European public assessment report (EPAR): Velsipity, Etrasimod, Status: Opinion
- Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive
- Human medicines European public assessment report (EPAR): Rimmyrah, ranibizumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Omjjara, momelotinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Rystiggo, Rozanolixizumab, Status: Opinion
- Summary of opinion: Talzenna, 09/11/2023 Positive
- Summary of opinion: Jardiance, 09/11/2023 Positive
- Summary of opinion: Evkeeza, 09/11/2023 Positive
- Human medicines European public assessment report (EPAR): Uzpruvo, ustekinumab, Status: Opinion
Orphan designations
- Orphan designation: botaretigene sparoparvovec Treatment of inherited retinal dystrophies due to defects in the RPGR gene, 23/07/2025 Positive
- Orphan designation: adeno-associated viral vector containing a modified U7 snRNA gene Treatment of Duchenne muscular dystrophy, 27/07/2005 Withdrawn
- Orphan designation: hydrocortisone Treatment of adrenal insufficiency, 20/03/2007 Withdrawn
- Orphan designation: nanatinostat,valganciclovir Treatment of peripheral T-cell lymphoma, 10/08/2022 Withdrawn
- Orphan designation: Interferon gamma Treatment of Friedreich's ataxia, 09/12/2011 Withdrawn
- Orphan designation: humanised IgG1 kappa monoclonal antibody against tyrosine-protein phosphatase non-receptor type substrate 1, signal-regulatory protein beta-1 and signal-regulatory protein gamma Treatment of haemophagocytic lymphohistiocytosis, 18/07/2025 Positive
- Orphan designation: allogeneic peripheral blood-derived T-cells, fratricide-resistant, transduced with a lentivirus vector expressing a chimeric antigen receptor against CD7 Treatment of acute lymphoblastic leukaemia, 18/07/2025 Positive
- Orphan designation: aglatimagene besadenovec Treatment of pancreatic cancer, 18/07/2025 Positive
- Orphan designation: methotrexate Treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotype, 18/07/2025 Positive
- Orphan designation: sonlicromanol hydrochloride Treatment of inherited mitochondrial oxidative phosphorylation defects, 18/07/2025 Positive
- Orphan designation: Ivosidenib Treatment of myelodysplastic syndromes, 18/07/2025 Positive
- Orphan designation: telitacicept Treatment of myasthenia gravis, 18/07/2025 Positive
- Orphan designation: curcumin Treatment of Charcot-Marie-Tooth disease, 18/07/2025 Positive
- Orphan designation: ribavirin Treatment of hepatitis E, 18/07/2025 Positive
- Orphan designation: avutometinib,defactinib Treatment of ovarian cancer, 18/07/2025 Positive
Public consultations
- Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1
- Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1
- Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)
- Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance
- Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance
- Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease
- Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
- ICH E20 guideline on adaptive designs for clinical trials - Step 2b
- Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water
- Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs
- Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
- Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)
- Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2
- ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
- Draft European Union herbal monograph on Ononis spinosa L., radix - Revision 1
Withdrawn applications
- Withdrawn application: Sileo, 30/08/2022
- Veterinary medicines European public assessment report (EPAR): Equilis EHV 1+4, Equine herpesvirus vaccine (inactivated), Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Tuzodi, midazolam, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Ifinwil, eflornithine, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Aplidin, plitidepsin, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Amtagvi, lifileucel, Status: Application withdrawn
- Withdrawn application: Lutathera, 09/05/2025
- Human medicines European public assessment report (EPAR): Teriparatide Ascend, teriparatide, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Dazluma, troriluzole, Status: Application withdrawn
- Withdrawn application: Dupixent, 18/02/2025
- Human medicines European public assessment report (EPAR): Rilonacept FGK Representative Service GmbH , rilonacept, Status: Application withdrawn
- Withdrawn application: Bimervax, 05/02/2025
- Human medicines European public assessment report (EPAR): Pelgraz Paediatric, pegfilgrastim, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Nugalviq, govorestat, Status: Application withdrawn
Paediatric investigation plans
- EMEA-001073-PIP02-14
- EMEA-002944-PIP02-22
- Opinion/decision on a Paediatric investigation plan (PIP): Sunlenca, lenacapavir sodium, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: P/0372/2024
- EMEA-003549-PIP01-23
- EMEA-003616-PIP01-24
- EMEA-003521-PIP01-23
- EMEA-003513-PIP01-23
- EMEA-003610-PIP01-24
- EMEA-003628-PIP01-24
- EMEA-003502-PIP01-23
- EMEA-003622-PIP01-24
- EMEA-003253-PIP01-22-M01
- EMEA-003344-PIP01-22-M01
- EMEA-003607-PIP01-24
- EMEA-003241-PIP01-22-M01