What’s new
- EMA decision on adoption by analogy of Commission decision C(2025) 2495
- Keeping medicines safe: Reporting side effects can make medicines safer for everyone
- HMPC: overview of assessment work - priority list
- Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 February 2026, 15:00 (CET) to 12 February 2026, 16:00 (CET)
- Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 March 2026, 15:00 (CET) to 12 March 2026, 16:00 (CET)
- Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2026, 15:00 (CEST) to 16 April 2026, 16:00 (CEST)
- Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 May 2026, 15:00 (CEST) to 13 May 2026, 16:00 (CEST)
- Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - February 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2026, 15:00 (CET) to 10 February 2026, 16:00 (CET)
- Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 March 2026, 15:00 (CET) to 10 March 2026, 16:00 (CET)
- Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 April 2026, 15:00 (CEST) to 14 April 2026, 16:00 (CEST)
- Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2026, 15:00 (CEST) to 12 May 2026, 16:00 (CEST)
- HMA-EMA joint Network Data Steering Group meeting - 6 October 2025
- Agenda of the CAT meeting 3-5 December 2025
- PSUSA/00002558/202501
- CAT quarterly highlights and approved ATMPs - December 2025
News and press releases
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 November 2025
- Call for expressions of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee
- Improved scientific advice for medicines for public health threats including antimicrobial resistance
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025
- First-in-class treatment to delay onset of type 1 diabetes
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 November 2025
- EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 - 30 October 2025
- ICMRA Summit 2025: EMA concludes its two mandates as chair
- EMA partners with content creators to promote safe and responsible use of GLP-1 medicines
- First treatment for serious chronic lung disease
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025
- EMA Management Board: highlights of October 2025 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025
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
- Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 January 2026, 15:00 (CET) to 15 January 2026, 16:00 (CET)
- Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026, 15:00 (CET) to 13 January 2026, 16:00 (CET)
- Committee for Medicinal Products for Veterinary Use (CVMP): 2-4 December 2025, European Medicines Agency, Amsterdam, the Netherlands, from 2 December 2025 to 4 December 2025
- Q&A clinic on Substance, Organisation, Referentials Management Services - January 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026, 11:00 (CET) to 13 January 2026, 12:00 (CET)
- SPOR and XEVMPD status update webinar - Q2 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 April 2026, 10:00 (CEST) to 13 April 2026, 12:30 (CEST)
- Third workshop between notified bodies and expert panels , Online, from 4 December 2025, 17:30 (CET) to 4 December 2025, 18:30 (CET)
- Kick-off meeting of the HMA-EMA group focused on AI with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 November 2025, 09:00 (CET) to 7 November 2025, 10:30 (CET)
- Eighth European Medicines Agency (EMA) and Medicines for Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 15 December 2025, 15:00 (CET) to 15 December 2025, 17:00 (CET)
- Clinical Trials Information System (CTIS): Walk-in clinic November 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 November 2025, 16:00 (CET) to 19 November 2025, 17:00 (CET)
- Seventh European Medicines Agency - EuropaBio bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 20 January 2026, 10:00 (CET) to 20 January 2026, 12:00 (CET)
- Sixth European Medicines Agency (EMA) and the Association of the European Self-Care Industry (AESGP) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 January 2026, 14:00 (CET) to 23 January 2026, 16:00 (CET)
- DARWIN EU Advisory Board meeting: 20 January 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 January 2025, 09:30 (CET) to 20 January 2025, 10:30 (CET)
- DARWIN EU Advisory Board meeting: 25 November 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024, 09:30 (CET) to 25 November 2024, 11:30 (CET)
- Cancer Medicines Forum: September 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 September 2025, 14:00 (CEST) to 4 September 2025, 17:00 (CEST)
- EMA - European Consumer Organisation (BEUC) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 10 November 2025
Regulatory and procedural guidelines (human and veterinary)
- Procedural advice for veterinary vaccine antigen master file (VAMF) certification
- Guidance for stepwise PIPs (sPIPs)
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
- Guide for rapporteurs and coordinators on the multinational assessment teams
- 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
Scientific guidelines (human and veterinary)
- Procedural advice for vaccine platform technology master file (vPTMF) certification
- Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)
- ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5
- 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
Agendas and Minutes
- HMA-EMA joint Network Data Steering Group meeting - 6 October 2025
- Agenda of the CAT meeting 3-5 December 2025
- Agenda of the CVMP meeting 2-4 December 2025
- Agenda of the COMP meeting 2-3 December 2025
- Minutes - Management Board meeting: 2 October 2025
- Meeting Summary - Medicine Shortages SPOC Working Party 14-15 October 2025
- Minutes - DARWIN EU Advisory Board - 20 January 2025
- Agenda - DARWIN EU Advisory Board - 20 January 2025
- Minutes - DARWIN EU Advisory Board - 25 November 2024
- Agenda - DARWIN EU Advisory Board - 25 November 2024
- Minutes of the Cancer Medicines Forum - September 2025
- Minutes of the COMP meeting 7-8 October 2025
- Agenda of the PRAC meeting 24 - 27 November 2025
- Minutes of the PRAC meeting 29 September - 2 October 2025
- Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 20 October 2025
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: carfilzomib Treatment of multiple myeloma, 03/06/2008 Expired
- Orphan designation: Obinutuzumab Treatment of follicular lymphoma, 19/06/2015 Withdrawn
- Orphan designation: recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009 Withdrawn
- 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
Public consultations
- Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease
- Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species
- Concept paper on a paediatric update of the guideline on clinical investigation of medicinal products for the management of Crohn’s disease
- Concept paper on a paediatric update on the guideline on the development of new medicinal products for the treatment of Ulcerative Colitis
- Draft guideline on non-inferiority and equivalence comparisons in clinical trials
- Draft qualification opinion for molecule-independent device bridging approach (MIDBA)
- Draft guideline on quality aspects of phage therapy medicinal products
- Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation
- 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
Withdrawn applications
- 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
- Human medicines European public assessment report (EPAR): Hydrocortisone Aguettant, Status: Application withdrawn
- 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
Paediatric investigation plans
- Opinion/decision on a Paediatric investigation plan (PIP): Ilumetri, tildrakizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0388/2024
- Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Renal and urinary disorders, PIP number: P/0387/2024
- Opinion/decision on a Paediatric investigation plan (PIP): Spevigo, spesolimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0341/2024
- EMEA-002284-PIP01-17
- EMEA-003153-PIP01-21
- EMEA-001489-PIP02-19
- EMEA-001489-PIP01-13-M02
- EMA/PE/0000246904
- EMA/PE/0000232853
- EMEA-003288-PIP01-22
- EMA/PE/0000231113
- EMA/PE/0000257243
- EMA/PE/0000221282
- EMA/PE/0000181891
- EMA/PE/0000225106