icon megaphone to show what's new on website

What’s new

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. Information on medicines and related procedures includes a reference to relevant substances: INN or common name, active substance, and English common name for herbal products. This overview covers up to two months back. 

Filter by

Categories
Clear

Results (435)

Date Content Status
20/03/2026
Event: EMA traineeship programme informative session
 New
20/03/2026
Medicine: Apremilast Accord apremilast
Updated
20/03/2026
Medicine: Cunitraxx fenbendazole
New
20/03/2026
PSUSA: PSUSA/00000402/202506 - periodic safety update report single assessment bethanechol
New
20/03/2026
Medicine: Ebglyss lebrikizumab
Updated
20/03/2026
PIP: EMA/PE/0000232315 - paediatric investigation plan spesolimab
Updated
20/03/2026
Medicine: Adcetris brentuximab vedotin
Updated
20/03/2026
Medicine: Evfraxy denosumab
Updated
20/03/2026
Document: MedDRA important medical event terms list - version 29.0
 Updated
20/03/2026
Document: EMA’s biennial report on stakeholder engagement activities 2024-2025
New
20/03/2026
Medicine: Xofluza baloxavir marboxil
Updated
20/03/2026
Page: Plant testing strategy in the risk assessment for veterinary medicinal products - Scientific guideline
 Updated
20/03/2026
Page: Guidance and template on the risk management plan (RMP) for novel therapy veterinary medicinal products - Scientific guideline
 New
20/03/2026
Page: EU Innovation Network (EU-IN)
 Updated
20/03/2026
Page: Chemistry of active substances (chemistry of new active substances) - Scientific guideline
 Updated
20/03/2026
Event: EMA workshop on the challenges in drug development, regulation and clinical practice in immune thrombocytopenia
 New
20/03/2026
Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2026
 New
20/03/2026
Document: Innovation Task Force (ITF) briefing meeting report
 Updated
20/03/2026
Event: European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry
 New
20/03/2026
Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2026
 Updated
20/03/2026
Document: Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports
 Updated
20/03/2026
Document: Overview of comments received on the draft Qualification opinion for Molecule-independent device bridging approach (MIDBA)
 New
20/03/2026
Document: Qualification opinion for Molecule-independent device bridging approach (MIDBA)
 New
20/03/2026
Medicine: Icatibant Accord icatibant
Updated
20/03/2026
Page: Electronic product information (ePI)
 Updated
20/03/2026
Document: Electronic product information (ePI) roadmap
 New
20/03/2026
Medicine: SonoVue sulphur hexafluoride
Updated
19/03/2026
Medicine: Xgeva denosumab
Updated
19/03/2026
Medicine: Vargatef nintedanib
Updated
19/03/2026
Medicine: Osenvelt denosumab
Updated
19/03/2026
Medicine: Libmyris adalimumab
Updated
19/03/2026
Medicine: Aerius desloratadine
Updated
19/03/2026
Medicine: Neoclarityn desloratadine
Updated
19/03/2026
Medicine: Kaftrio ivacaftor; tezacaftor; elexacaftor
Updated
19/03/2026
Medicine: Hympavzi marstacimab
Updated
19/03/2026
Medicine: Imfinzi durvalumab
Updated
19/03/2026
Medicine: Lynparza olaparib
Updated
19/03/2026
Document: Article 57 product data
 Updated
19/03/2026
Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants
 Updated
19/03/2026
Document: QRD veterinary Appendix I - Adverse event (PhV) MSs reporting details
 Updated
19/03/2026
Document: Innovation Task Force (ITF) briefing meeting request form
 Updated
19/03/2026
Document: 2025 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission
 New
19/03/2026
Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP
 Updated
19/03/2026
Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)
 Updated
19/03/2026
Event: ACT EU webinar on contractual agreements
Updated
19/03/2026
Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications
 Updated
19/03/2026
Medicine: Kostaive zapomeran
Updated
19/03/2026
Document: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (1 January - 31 December 2025)
 Updated
19/03/2026
PSUSA: PSUSA/00001324/202505 - periodic safety update report single assessment etodolac
New
19/03/2026
PSUSA: PSUSA/00001040/202507 - periodic safety update report single assessment diclofenac / misoprostol
New
18/03/2026
PSUSA: PSUSA/00001672/202508 - periodic safety update report single assessment hydrocortisone / natamycin / neomycine sulphate
New
18/03/2026
PSUSA: PSUSA/00002149/202505 - periodic safety update report single assessment nicardipine
New
18/03/2026
Medicine: Voranigo vorasidenib
Updated
18/03/2026
Medicine: Deltyba delamanid
Updated
18/03/2026
Medicine: Keytruda pembrolizumab
Updated
18/03/2026
Medicine: Strensiq asfotase alfa
Updated
18/03/2026
Medicine: Akynzeo netupitant; palonosetron
Updated
18/03/2026
Medicine: Opdivo nivolumab
Updated
18/03/2026
PSUSA: PSUSA/00003146/202507 - periodic safety update report single assessment ziprasidone
New
18/03/2026
PSUSA: PSUSA/00001476/202508 - periodic safety update report single assessment fosphenytoin
New
18/03/2026
Medicine: Zynyz retifanlimab
Updated
18/03/2026
Page: PRIME: priority medicines
 Updated
18/03/2026
News: New PRIME tools to accelerate development of medicines in the EU
 New
18/03/2026
Page: Website outages and upgrades
 Updated
18/03/2026
EU-M4all: Mosquirix - opinion on medicine for use outside EU Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)
Updated
18/03/2026
Medicine: Vaborem meropenem; vaborbactam
Updated
18/03/2026
Document: Network Portfolio Roadmap
 Updated
18/03/2026
Medicine: Veoza fezolinetant
Updated
18/03/2026
Medicine: Cegfila (previously Pegfilgrastim Mundipharma) pegfilgrastim
Updated
18/03/2026
Medicine: Pelmeg pegfilgrastim
Updated
18/03/2026
Page: Quality Innovation Group
 Updated
17/03/2026
Event: EMA Veterinary Medicines Info Day 2026
 Updated
17/03/2026
Medicine: Gohibic vilobelimab
Updated
17/03/2026
Document: Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568
 Updated
17/03/2026
Medicine: Elfabrio pegunigalsidase alfa
Updated
17/03/2026
Referral: Melatomed and associated names - referral melatonin
Updated
17/03/2026
Medicine: Gazyvaro obinutuzumab
Updated
17/03/2026
Document: Questions and answers on the refusal of a change to the marketing authorisation for Hetlioz (tasimelteon) (X-39)
 Updated
17/03/2026
Document: Questions and answers on the refusal of a change to the marketing authorisation for Hetlioz (tasimelteon) (II-40)
 Updated
17/03/2026
Medicine: Daybu trofinetide
Updated
17/03/2026
Medicine: Plegridy peginterferon beta-1a
Updated
17/03/2026
Referral: Quarter-based selective dry cow therapy - referral
 Updated
17/03/2026
PSUSA: PSUSA/00000777/202507 - periodic safety update report single assessment cisatracurium
New
17/03/2026
PSUSA: PSUSA/00010502/202507 - periodic safety update report single assessment pitavastatin
New
17/03/2026
Medicine: Pemazyre pemigatinib
Updated
17/03/2026
Medicine: Bimzelx bimekizumab
Updated
17/03/2026
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
17/03/2026
Medicine: Akeega niraparib; abiraterone acetate
Updated
17/03/2026
Medicine: Trydonis beclometasone; formoterol; glycopyrronium bromide
Updated
17/03/2026
Medicine: Trimbow beclometasone; formoterol; glycopyrronium bromide
Updated
17/03/2026
PSUSA: PSUSA/00001763/202508 - periodic safety update report single assessment iodine (123i) iobenguane
New
17/03/2026
PSUSA: PSUSA/00001775/202506 - periodic safety update report single assessment ioversol
New
17/03/2026
PSUSA: PSUSA/00001552/202507 - periodic safety update report single assessment glyceryl trinitrate
New
17/03/2026
PSUSA: PSUSA/00010068/202507 - periodic safety update report single assessment beclometasone / formoterol
New
17/03/2026
Document: Template for a request for amendments of or addition of active substances or combinations of active substances to the European Union reference-date list
 Updated
17/03/2026
PSUSA: PSUSA/00000210/202508 - periodic safety update report single assessment anastrozole
New
17/03/2026
PSUSA: PSUSA/00001824/202507 - periodic safety update report single assessment lamivudine
New
17/03/2026
PSUSA: PSUSA/00000640/202508 - periodic safety update report single assessment cetylpyridinium / lysozyme, lysozyme / pyridoxine
New
17/03/2026
PSUSA: PSUSA/00002286/202508 - periodic safety update report single assessment amoxicillin / clarithromycin / pantoprazole
New
17/03/2026
PSUSA: PSUSA/00010748/202507 - periodic safety update report single assessment octenidine
New
17/03/2026
Page: Clinical pharmacology and pharmacokinetics: questions and answers
 Updated
17/03/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
17/03/2026
Document: Agenda - Medicine Shortages SPOC Working Party meeting 16-17 March 2026
 New
17/03/2026
Medicine: Ozempic semaglutide
Updated
17/03/2026
Document: Antimicrobial Sales and Use (ASU) Power BI application user guide
 Updated
17/03/2026
Document: Antimicrobial Sales and Use (ASU) platform user guide
 Updated
17/03/2026
Document: Agenda - Management Board meeting: 12 March 2026
 Updated
17/03/2026
Document: Records of data processing activity for women leadership development and mentoring activities
 New
17/03/2026
Event: Committee for Orphan Medicinal Products (COMP): 17-19 March 2026
 Updated
16/03/2026
Event: Quarterly System Demo - Q1 2026
 Updated
16/03/2026
Page: Stakeholders and Communication
 Updated
16/03/2026
Document: HMPC: overview of assessment work - priority list
 Updated
16/03/2026
Event: Paediatric Committee (PDCO): 27-30 January 2026
 Updated
16/03/2026
Page: Procedures for monograph and list entry establishment
 Updated
16/03/2026
Herbal: Tormentillae rhizoma - herbal medicinal product Tormentil
Updated
16/03/2026
Herbal: Leonuri cardiacae herba - herbal medicinal product Motherwort
Updated
16/03/2026
Herbal: Thymi aetheroleum - herbal medicinal product Thyme oil
Updated
16/03/2026
Herbal: Taraxaci radix cum herba - herbal medicinal product Dandelion Root with Herb
Updated
16/03/2026
Herbal: Taraxaci folium - herbal medicinal product Dandelion Leaf
Updated
16/03/2026
Herbal: Tanaceti parthenii herba - herbal medicinal product Feverfew
Updated
16/03/2026
Herbal: Quercus cortex - herbal medicinal product Oak Bark
Updated
16/03/2026
Herbal: Phaseoli fructus (sine semine) - herbal medicinal product Green bean pod
Updated
16/03/2026
Herbal: Millefolii herba - herbal medicinal product Yarrow
Updated
16/03/2026
Event: Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 16 March 2026
 New
16/03/2026
Herbal: Millefolii flos - herbal medicinal product Yarrow Flower
Updated
16/03/2026
Herbal: Menthae piperitae folium - herbal medicinal product peppermint leaf
Updated
16/03/2026
Herbal: Menthae piperitae aetheroleum - herbal medicinal product Peppermint oil
Updated
16/03/2026
Herbal: Herniariae herba - herbal medicinal product Rupturewort
Updated
16/03/2026
Herbal: Filipendulae ulmariae herba - herbal medicinal product Meadowsweet
Updated
16/03/2026
Herbal: Filipendulae ulmariae flos - herbal medicinal product Meadowsweet Flower
Updated
16/03/2026
Herbal: Chamomillae romanae flos - herbal medicinal product Roman Chamomile Flower
Updated
16/03/2026
Herbal: Arctii radix - herbal medicinal product Burdock Root
Updated
16/03/2026
Herbal: Absinthii herba - herbal medicinal product Wormwood
Updated
16/03/2026
PSUSA: PSUSA/00010801/202507 - periodic safety update report single assessment poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated), poliovirus type 1 / poliovirus type 3 vaccine (oral, live, attenuated),poliovirus type 1 (oral, live, attenuated) vaccine, poliovirus type 2 (oral, live, attenuated) vaccine, poliovirus type 3 (oral, live, attenuated) vaccine
New
16/03/2026
Event: Workshop on Vulnerability Assessment
 New
16/03/2026
Event: EMA - Alzheimer Europe (AE) bilateral meeting
 New
16/03/2026
PIP: EMEA-001272-PIP02-13-M01 - paediatric investigation plan azacitidine
Updated
16/03/2026
PIP: EMEA-002741-PIP01-20-M02 - paediatric investigation plan fordadistrogene movaparvovec
Updated
16/03/2026
Document: Release notes - production release version 1.7.2615 March 2026 - Veterinary Medicinal Products Regulation: Union Product Database
 New
13/03/2026
Medicine: Carvykti ciltacabtagene autoleucel
Updated
13/03/2026
Medicine: Pradaxa dabigatran etexilate
Updated
13/03/2026
Medicine: Wegovy semaglutide
Updated
13/03/2026
Medicine: Orphacol cholic acid
Updated
13/03/2026
PSUSA: PSUSA/00001102/202507 - periodic safety update report single assessment dimetindene / phenylephrine
New
13/03/2026
PSUSA: PSUSA/00000061/202508 - periodic safety update report single assessment ademetionine
New
13/03/2026
Page: Qualification of non-mutagenic impurities - Scientific guideline
 Updated
13/03/2026
Medicine: Vazkepa icosapent ethyl
Updated
13/03/2026
Medicine: Arsenic trioxide Accord arsenic trioxide
Updated
13/03/2026
Document: Joint Controllership Arrangement with regard to the Clinical Trials Information System (CTIS)
 Updated
13/03/2026
Document: European Medicines Agency's data protection notice regarding personal data processing in the Clinical Trials Information System (CTIS)
 Updated
13/03/2026
Document: Questions and Answers on the Joint Controllership Arrangement and data protection matters related to the use of the Clinical Trials Information System
 Updated
13/03/2026
Medicine: Xerava eravacycline
Updated
13/03/2026
Medicine: Skyclarys omaveloxolone
Updated
13/03/2026
Medicine: Vizamyl flutemetamol (18F)
Updated
13/03/2026
Document: Darwin EU: Making health data count
 Updated
13/03/2026
Medicine: Anktiva nogapendekin alfa inbakicept
Updated
13/03/2026
Page: Availability of medicines before and during crises
 Updated
13/03/2026
Page: Union list of critical medicines
 Updated
13/03/2026
News: EMA Management Board: highlights of March 2026 meeting
 New
13/03/2026
Page: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
 Updated
13/03/2026
Medicine: AviGate S. Infantis Salmonella Infantis vaccine (live)
New
13/03/2026
Medicine: VeroBlue-3 bluetongue virus vaccine (inactivated)
New
13/03/2026
News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 March 2026
 New
13/03/2026
Medicine: Ebymect dapagliflozin; metformin
Updated
13/03/2026
Medicine: Edistride dapagliflozin
Updated
13/03/2026
Medicine: Qtern saxagliptin; dapagliflozin
Updated
13/03/2026
Medicine: Xigduo dapagliflozin; metformin
Updated
13/03/2026
Page: Data protection and privacy at EMA
 Updated
13/03/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 March 2026
 New
13/03/2026
Document: Appendix 1: Acceptable intakes established for N-nitrosamines
 Updated
13/03/2026
Page: Union Product Database
 Updated
13/03/2026
Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Example payloads for API
 New
13/03/2026
Document: Records of data processing activity relating to temporary agency workers (interims)
 New
13/03/2026
Document: European Medicines Agency’s data protection notice for women leadership development and mentoring activities
 New
13/03/2026
Event: Management Board meeting: 12 March 2026
 Updated
13/03/2026
Document: Minutes - HMA-EMA joint Network Data Steering Group meeting - 11 February 2026
 New
13/03/2026
Page: Development of anti-cancer medicinal products in paediatric patients - Scientific guideline
 New
13/03/2026
Document: Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
 New
12/03/2026
Medicine: Elucirem gadopiclenol
Updated
12/03/2026
Medicine: Vueway gadopiclenol
Updated
12/03/2026
Medicine: Tecartus brexucabtagene autoleucel
Updated
12/03/2026
Medicine: Yescarta axicabtagene ciloleucel
Updated
12/03/2026
Medicine: Forxiga dapagliflozin
Updated
12/03/2026
Medicine: Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) lenalidomide
Updated
12/03/2026
Medicine: Quviviq daridorexant
Updated
12/03/2026
Herbal: Zingiberis rhizoma - herbal medicinal product Ginger
Updated
12/03/2026
Herbal: Trigonellae foenugraeci semen - herbal medicinal product Fenugreek seed
Updated
12/03/2026
Medicine: Eliquis apixaban
Updated
12/03/2026
Herbal: Rosmarini folium - herbal medicinal product Rosemary leaf
Updated
12/03/2026
Medicine: Exdensur depemokimab
Updated
12/03/2026
Herbal: Rosmarini aetheroleum - herbal medicinal product Rosemary oil
Updated
12/03/2026
Herbal: Pilosellae herba cum radice - herbal medicinal product Mouse-ear hawkweed
Updated
12/03/2026
Herbal: Ginseng radix - herbal medicinal product Ginseng
Updated
12/03/2026
Herbal: Cnici benedicti herba - herbal medicinal product St. Benedict's thistle (also blessed thistle, holy thistle or spotted thistle)
Updated
12/03/2026
Document: List of medicines currently in PRIME scheme
 Updated
12/03/2026
Event: Clinical Trials Information System (CTIS): Walk-in clinic April 2026
 New
12/03/2026
Page: Article 141(1) opinions on any scientific matter: veterinary medicines
 Updated
12/03/2026
Page: Veterinary antibiotics: Dosage review and adjustment (ADRA) project
 New
12/03/2026
PIP: EMA/PE/0000226246 - paediatric investigation plan marstacimab
Updated
12/03/2026
PIP: EMA/PE/0000226217 - paediatric investigation plan bictegravir; emtricitabine; tenofovir alafenamide
Updated
12/03/2026
Medicine: Rxulti brexpiprazole
Updated
12/03/2026
PIP: EMA/PE/0000225746 - paediatric investigation plan atogepant
Updated
12/03/2026
PIP: EMA/PE/0000226088 - paediatric investigation plan relacorilant
Updated
12/03/2026
Document: CAT quarterly highlights and approved ATMPs - March 2026
 New
12/03/2026
PIP: EMA/PE/0000225073 - paediatric investigation plan recombinant parathyroid hormone
New
12/03/2026
PIP: EMA/PE/0000225023 - paediatric investigation plan efgartigimod alfa
New
12/03/2026
PIP: EMA/PE/0000224955 - paediatric investigation plan ribitol
Updated
12/03/2026
PIP: EMA/PE/0000224883 - paediatric investigation plan rinatabart sesutecan
New
12/03/2026
PIP: EMA/PE/0000225241 - paediatric investigation plan calcium chloride dihydrate; magnesium chloride hexahydrate; sodium chloride; sodium lactate; xylitol; d-glucose; levocarnitine
New
12/03/2026
PIP: EMA/PE/0000224912 - paediatric investigation plan cannabidiol
Updated
11/03/2026
PIP: EMA/PE/0000224768 - paediatric investigation plan vosoritide
Updated
11/03/2026
PIP: EMEA-001652-PIP01-14-M06 - paediatric investigation plan cariprazine hydrochloride
Updated
11/03/2026
PIP: EMA/PE/0000224283 - paediatric investigation plan pegcetacoplan
Updated
11/03/2026
Document: Applications for new human medicines under evaluation: March 2026
 New
11/03/2026
Herbal: Valerianae radix - herbal medicinal product Valerian Root
Updated
11/03/2026
Document: Minutes of the COMP meeting 20-22 January 2026
 New
11/03/2026
PSUSA: PSUSA/00002004/202505 - periodic safety update report single assessment methadone
New
11/03/2026
Document: DARWIN EU Advisory Board: Membership
 Updated
11/03/2026
Document: Agenda of the CVMP meeting 10-12 March 2026
 Updated
11/03/2026
PIP: EMA/PE/0000224175 - paediatric investigation plan azamidugene autotemcel (OTL-203)
Updated
11/03/2026
PIP: EMEA-003026-PIP02-21 - paediatric investigation plan whole-cell heat-inactivated bacterial strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcus faecalis
Updated
11/03/2026
PIP: EMEA-003639-PIP01-24 - paediatric investigation plan adeno-associated virus serotype 9 vector containing the human LAMP2 isoform B transgene (RP-A501)
New
11/03/2026
PIP: EMEA-003636-PIP01-24 - paediatric investigation plan respiratory syncytial virus, prefusion F protein, virus-like particle / human metapneumovirus, prefusion F protein, virus-like particle (IVX-A12)
New
11/03/2026
PIP: EMEA-003635-PIP01-24 - paediatric investigation plan heterologous intestinal microbiota from healthy donors (MBK-01)
New
11/03/2026
Document: Minutes of the PRAC meeting 12 - 15 January 2026
 New
11/03/2026
Medicine: Winrevair sotatercept
Updated
11/03/2026
PIP: EMEA-001161-PIP02-11-M03 - paediatric investigation plan Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
Updated
11/03/2026
PIP: EMEA-003119-PIP01-21-M01 - paediatric investigation plan zuranolone
Updated
11/03/2026
PIP: EMA/PE/0000224110 - paediatric investigation plan esketamine hydrochloride
Updated
11/03/2026
PIP: EMEA-003604-PIP01-24 - paediatric investigation plan luliconazole
New
11/03/2026
Medicine: Vitrakvi larotrectinib
Updated
11/03/2026
Medicine: Vimpat lacosamide
Updated
11/03/2026
PIP: EMEA-003161-PIP02-24 - paediatric investigation plan golcadomide hydrochloride
New
11/03/2026
PIP: EMEA-003533-PIP01-23 - paediatric investigation plan livmoniplimab
New
11/03/2026
PIP: EMEA-003532-PIP01-23 - paediatric investigation plan budigalimab
New
11/03/2026
PIP: EMEA-002476-PIP03-24 - paediatric investigation plan letetresgene autoleucel
New
11/03/2026
Medicine: Spinraza nusinersen
Updated
11/03/2026
Medicine: Kirsty (previously Kixelle) insulin aspart
Updated
11/03/2026
Medicine: Lysodren mitotane
Updated
11/03/2026
Document: Vaxchora: avoiding errors when making up and using the vaccine
 Updated
11/03/2026
PIP: EMA/PE/0000223656 - paediatric investigation plan givinostat
Updated
11/03/2026
PIP: EMA/PE/0000223608 - paediatric investigation plan molnupiravir
Updated
10/03/2026
PIP: EMA/PE/0000230373 - paediatric investigation plan rinatabart sesutecan
New
10/03/2026
PIP: EMA/PE/0000230375 - paediatric investigation plan rinatabart sesutecan
New
10/03/2026
PIP: EMA/PE/0000223523 - paediatric investigation plan paltusotine
New
10/03/2026
PIP: EMA/PE/0000223677 - paediatric investigation plan coramitug
New
10/03/2026
PIP: EMA/PE/0000228821 - paediatric investigation plan zelenectide pevedotin
New
10/03/2026
PIP: EMA/PE/0000228365 - paediatric investigation plan botensilimab
New
10/03/2026
Medicine: Iloperidone Vanda Pharmaceuticals iloperidone
Updated
10/03/2026
PSUSA: PSUSA/00002828/202504 - periodic safety update report single assessment sulprostone
New
10/03/2026
Medicine: Ponvory ponesimod
Updated
10/03/2026
Medicine: Kengrexal cangrelor
Updated
10/03/2026
Medicine: Lydisilka estetrol; drospirenone
Updated
10/03/2026
Medicine: Drovelis estetrol; drospirenone
Updated
10/03/2026
Document: Record of data processing activity for EudraVigilance
Updated
10/03/2026
Page: Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert panel opinions
 Updated
10/03/2026
Page: High-risk medical devices: consultation procedures
 Updated
10/03/2026
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
 Updated
10/03/2026
Medicine: Amversio betaine anhydrous
Updated
10/03/2026
PIP: EMA/PE/0000228360 - paediatric investigation plan ezetimibe; rosuvastatin
New
10/03/2026
PIP: EMA/PE/0000228114 - paediatric investigation plan mesdopetam
New
10/03/2026
PIP: EMA/PE/0000228097 - paediatric investigation plan sacituzumab govitecan
New
10/03/2026
PIP: EMA/PE/0000227674 - paediatric investigation plan zampilimab
New
10/03/2026
PIP: EMA/PE/0000228776 - paediatric investigation plan abemaciclib
Updated
10/03/2026
PIP: EMA/PE/0000228333 - paediatric investigation plan sufentanil citrate; ketamine (hydrochloride)
Updated
10/03/2026
PSUSA: PSUSA/00000383/202506 - periodic safety update report single assessment benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin
New
10/03/2026
PSUSA: PSUSA/00001126/202507 - periodic safety update report single assessment diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)
New
10/03/2026
PSUSA: PSUSA/00002453/202505 - periodic safety update report single assessment pneumococcal polysaccharide vaccine
New
10/03/2026
PSUSA: PSUSA/00002312/202506 - periodic safety update report single assessment caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine / paracetamol
New
10/03/2026
Medicine: Teduglutide Viatris teduglutide
Updated
10/03/2026
Medicine: Alkindi hydrocortisone
Updated
10/03/2026
Document: European Medicines Agency’s data protection notice for the EudraVigilance Signal and Safety Analytics (EV SSA) platform
 Updated
10/03/2026
Page: Supporting innovation
 Updated
10/03/2026
Page: Portfolio and technology meetings
 Updated
10/03/2026
Document: Portfolio and technology meeting briefing document
Updated
10/03/2026
Event: PCWP/HCPWP joint meeting
 Updated
10/03/2026
Document: Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool
 Updated
10/03/2026
Document: Methodology to identify vulnerabilities in supply chains of critical medicines
 New
10/03/2026
Document: SMS guidance for external users
 Updated
10/03/2026
Event: Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 March 2026
 Updated
09/03/2026
Page: Eligible healthcare professionals' organisations
 Updated
09/03/2026
Document: Network Data Steering Group workplan 2026-2028: Data and artificial intelligence in medicines regulation
 New
09/03/2026
Page: Network Data Steering Group (NDSG)
 Updated
09/03/2026
PIP: EMEA-001502-PIP01-13 - paediatric investigation plan adeno-associated viral vector serotype 9 containing human sulfamidase gene
Updated
09/03/2026
PIP: EMEA-001722-PIP01-14-M02 - paediatric investigation plan eteplirsen
Updated
09/03/2026
Document: Record of data processing activity relating to Security Access Control System
 Updated
09/03/2026
PSUSA: PSUSA/00001499/202502 - periodic safety update report single assessment gabapentin
Updated
09/03/2026
Medicine: Nucala mepolizumab
Updated
09/03/2026
Medicine: Cayston aztreonam
Updated
09/03/2026
PIP: EMEA-003550-PIP01-23 - paediatric investigation plan humanized IgG4 Monoclonal Antibody against FIXa and FX (NXT007)
New
09/03/2026
Document: Agenda of the PRAC meeting 9-12 March 2026
 New
09/03/2026
PIP: EMEA-003502-PIP02-24 - paediatric investigation plan mezagitamab
New
09/03/2026
Page: PRAC recommendations on safety signals
 Updated
09/03/2026
Document: PRAC recommendations on signals adopted at the 9-12 February 2026 PRAC meeting
 New
09/03/2026
Document: List of signals discussed at PRAC since September 2012
 Updated
09/03/2026
Event: Webinar on the use of platform approaches in the non-clinical and clinical domains
 Updated
09/03/2026
PIP: EMA/PE/0000243095 - paediatric investigation plan teplizumab
Updated
09/03/2026
PIP: EMA/PE/0000232930 - paediatric investigation plan mirikizumab
Updated
09/03/2026
PIP: EMA/PE/0000232848 - paediatric investigation plan mirikizumab
Updated
09/03/2026
Document: National Innovation Offices Contacts
 Updated
09/03/2026
Page: Organisation Management Service (OMS)
 Updated
06/03/2026
PIP: EMA/PE/0000222532 - paediatric investigation plan tofacitinib
Updated
06/03/2026
PIP: EMA/PE/0000221604 - paediatric investigation plan ravulizumab
Updated
06/03/2026
PIP: EMA/PE/0000221583 - paediatric investigation plan famtozinameran; riltozinameran; tozinameran
Updated
06/03/2026
PIP: EMA/PE/0000225594 - paediatric investigation plan imlifidase
Updated
06/03/2026
PIP: EMA/PE/0000221462 - paediatric investigation plan [225Ac]Ac-PSMA-617
New
06/03/2026
PIP: EMA/PE/0000221213 - paediatric investigation plan blinatumomab
Updated
06/03/2026
PIP: EMA/PE/0000221296 - paediatric investigation plan ravulizumab
Updated
06/03/2026
PIP: EMA/PE/0000184081 - paediatric investigation plan etrasimod
Updated
06/03/2026
PIP: EMA/PE/0000183827 - paediatric investigation plan tabelecleucel
Updated
06/03/2026
PIP: EMA/PE/0000182607 - paediatric investigation plan Maribavir
Updated
06/03/2026
PIP: EMA/PE/0000182245 - paediatric investigation plan 5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one
New
06/03/2026
PIP: EMA/PE/0000182075 - paediatric investigation plan venetoclax
Updated
06/03/2026
PIP: EMA/PE/0000181243 - paediatric investigation plan glutamatergic neurotransmission enhancer BI 1569912
New
06/03/2026
PIP: EMA/PE/0000181174 - paediatric investigation plan Dasiglucagon
Updated
06/03/2026
PIP: EMA/PE/0000181050 - paediatric investigation plan lonigutamab
New
06/03/2026
Medicine: Sprycel dasatinib (anhydrous)
Updated
06/03/2026
Document: Minutes of the HMPC meeting 19-21 January 2026
 New
06/03/2026
Document: Opinion of the CVMP on the establishment of maximum residue limits: Fluralaner ( EMEA/V/MRL/004380/EXTN/0002)
 New
06/03/2026
Document: Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)
 New
06/03/2026
Page: ICH E2D post-approval safety data management - scientific guideline
 Updated
06/03/2026
Document: EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
 New
06/03/2026
Document: Highlight report - Combination Products Operational Group (COMBO) - In Vitro Diagnostics stream - February 2026
 New
06/03/2026
PSUSA: PSUSA/00000594/202506 - periodic safety update report single assessment cefixime
New
06/03/2026
Medicine: MicardisPlus telmisartan; hydrochlorothiazide
Updated
06/03/2026
Medicine: Tyruko natalizumab
Updated
06/03/2026
Event: 16th Industry Standing Group (ISG) meeting
 Updated
06/03/2026
PSUSA: PSUSA/00002846/202504 - periodic safety update report single assessment tamoxifen
New
06/03/2026
Page: Orphan designation: Overview
 Updated
05/03/2026
Medicine: Inhixa enoxaparin sodium
Updated
05/03/2026
Medicine: Waskyra etuvetidigene autotemcel
Updated
05/03/2026
PIP: EMA/PE/0000225681 - paediatric investigation plan recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1
Updated
05/03/2026
PIP: EMA/PE/0000225592 - paediatric investigation plan ulixacaltamide (hydrochloride)
New
05/03/2026
PIP: EMA/PE/0000225245 - paediatric investigation plan nedosiran
Updated
05/03/2026
PIP: EMA/PE/0000223498 - paediatric investigation plan Infigratinib
Updated
05/03/2026
PIP: EMA/PE/0000223490 - paediatric investigation plan Eptinezumab
Updated
05/03/2026
PIP: EMA/PE/0000223351 - paediatric investigation plan Cipaglucosidase alfa
Updated
05/03/2026
PIP: EMA/PE/0000223288 - paediatric investigation plan evenamide
Updated
05/03/2026
PIP: EMA/PE/0000222938 - paediatric investigation plan Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY); Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein; recombinant Neisseria meningitidis serogroup B protein 1; recombinant Neisseria meningitidis serogroup B protein 2; recombinant Neisseria meningitidis serogroup B protein 3; Neisseria meningitidis serogroup B Protein-based active substance (MenPenta vaccine)
Updated
05/03/2026
PIP: EMEA-003219-PIP01-22 - paediatric investigation plan inclacumab
Updated
05/03/2026
PSUSA: PSUSA/00001855/202505 - periodic safety update report single assessment levomethadone
New
05/03/2026
Post-authorisation: Scenesse - withdrawal of application for variation to marketing authorisation afamelanotide
Updated
05/03/2026
Medicine: Toujeo (previously Optisulin) insulin glargine
Updated
05/03/2026
Medicine: Apidra insulin glulisine
Updated
05/03/2026
Medicine: VacPertagen pertussis vaccine (recombinant, acellular, component, adsorbed)
Updated
05/03/2026
Medicine: Lantus insulin glargine
Updated
05/03/2026
Medicine: Insuman insulin human
Updated
05/03/2026
Medicine: Imatinib Teva imatinib
Updated
05/03/2026
Page: Variations not requiring assessment (veterinary medicines)
 Updated
05/03/2026
Page: Transferring a veterinary marketing authorisation
 Updated
05/03/2026
Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)
 Updated
05/03/2026
Page: Clinical trials in human medicines
 Updated
05/03/2026
Page: Product-information requirements for veterinary medicines
 Updated
05/03/2026
News: New guidance on the conduct of clinical trials during public health emergencies in the EU
 New
05/03/2026
Medicine: Simponi golimumab
Updated
05/03/2026
Document: Agenda - Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026
 New
05/03/2026
Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026
 New
04/03/2026
Medicine: Eylea aflibercept
Updated
04/03/2026
Page: Plasma master file certificates
 Updated
04/03/2026
Medicine: mNexspike COVID-19 mRNA vaccine
Updated
04/03/2026
Medicine: Kefdensis denosumab
Updated
04/03/2026
Medicine: Otezla apremilast
Updated
04/03/2026
Medicine: Leqvio inclisiran
Updated
04/03/2026
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
 Updated
04/03/2026
PIP: EMA/PE/0000230484 - paediatric investigation plan alprazolam
Updated
04/03/2026
PIP: EMA/PE/0000227908 - paediatric investigation plan nerandomilast
Updated
04/03/2026
PIP: EMA/PE/0000227558 - paediatric investigation plan danicopan
Updated
04/03/2026
PIP: EMA/PE/0000227526 - paediatric investigation plan ceftobiprole medocaril (sodium)
Updated
04/03/2026
PIP: EMA/PE/0000227462 - paediatric investigation plan deucrictibant monohydrate
Updated
04/03/2026
PIP: EMA/PE/0000227425 - paediatric investigation plan efgartigimod alfa
Updated
04/03/2026
Medicine: Hemgenix etranacogene dezaparvovec
Updated
04/03/2026
PIP: EMA/PE/0000227394 - paediatric investigation plan tezacaftor; ivacaftor
Updated
04/03/2026
PIP: EMA/PE/0000226957 - paediatric investigation plan efgartigimod alfa
Updated
04/03/2026
Document: Draft guidance on the conduct of clinical trials during public health emergencies
 New
04/03/2026
Document: Records of data processing activity for the handling the contribution towards commuting costs
 Updated
04/03/2026
Medicine: Xevudy sotrovimab
Updated
04/03/2026
Page: Data Analysis and Real World Interrogation Network (DARWIN EU)
 Updated
04/03/2026
Document: DARWIN EU data partners onboarded in phases I, II, III and IV
 Updated
04/03/2026
Document: Darwin EU study: Co-prescribing medicines in pulmonary arterial hypertension
 New
04/03/2026
Document: Darwin EU study: How medicines are used to treat adults and children with lupus
 New
04/03/2026
Document: Darwin EU study: Clozapine and the incidence of severe neutropenia over time
 New
04/03/2026
Document: Darwin EU study: Treatment patterns and user characteristics for novel migraine medicines
 New
04/03/2026
Document: Darwin EU study: Overall survival in patients with non-small cell lung cancer treated with selected immunotherapies
 New
04/03/2026
Document: Darwin EU: Is there a risk of suicidality after taking the antibiotic doxycycline
 New
04/03/2026
Document: Darwin EU study: Is there a link between blood clots and common painkillers in women who use hormonal birth control
 New
04/03/2026
Document: Darwin EU: How often respiratory syncytial virus (RSV) affects different age groups in Europe
 New
04/03/2026
Document: Darwin EU study: Use of higher-risk antibiotics from the WHO Watch list, including azithromycin
 New
04/03/2026
Document: Darwin EU study: Background incidence rates of selected vaccine adverse events of special in Europe
 New
03/03/2026
Document: Annual report on the use of the special contribution for orphan medicinal products - 2025
 New
03/03/2026
Document: Questions and answers on the use of out-of-specification batches of authorised cell and tissue-based advanced therapy medicinal products
 Updated
03/03/2026
Document: Consolidated 3-year work plan for the clinical domain
 New
03/03/2026
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 February 2026
 New
03/03/2026
Page: Medicines for human use under evaluation
 Updated
03/03/2026
PIP: EMA/PE/0000228283 - paediatric investigation plan balstilimab
New
03/03/2026
Medicine: Afqlir aflibercept
Updated
03/03/2026
Shortage: Ifosfamide ifosfamide
Updated
03/03/2026
Shortage: Cyclophosphamide cyclophosphamide
Updated
03/03/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
03/03/2026
PIP: EMA/PE/0000226753 - paediatric investigation plan mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein; mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein; mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein
New
03/03/2026
Medicine: Entyvio vedolizumab
Updated
16/02/2023
News: Human medicines: highlights of 2022
 New
03/03/2026
Document: Human medicines highlights 2022
 Updated
03/03/2026
Medicine: Zeposia ozanimod
Updated
03/03/2026
Medicine: Vyloy zolbetuximab
Updated
03/03/2026
Medicine: Myqorzo aficamten
Updated
03/03/2026
Medicine: Aqneursa L-acetylleucine
Updated
03/03/2026
Page: Artificial intelligence
 Updated
03/03/2026
Document: Scientific Explorer - Frequently Asked Questions
 Updated
03/03/2026
Document: Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6
 Updated
02/03/2026
Page: Fees for veterinary medicines
 Updated
02/03/2026
Herbal: Combination: Hyperici herba - herbal medicinal product St. John's Wort
Updated
02/03/2026
Medicine: Lotilaner / Milbemycin Elanco lotilaner; milbemycin oxime
Updated
02/03/2026
Medicine: Nivestim filgrastim
Updated
02/03/2026
Medicine: Retacrit epoetin zeta
Updated
02/03/2026
Medicine: Lamzede velmanase alfa
Updated
02/03/2026
Medicine: Fingolimod Accord fingolimod
Updated
02/03/2026
Medicine: Rasilez aliskiren
Updated
02/03/2026
Event: 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan
 New
02/03/2026
Medicine: Pylclari piflufolastat (18F)
Updated
02/03/2026
Medicine: Herceptin trastuzumab
Updated
02/03/2026
Page: One Health approach
 Updated
02/03/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - February 2026
 Updated
02/03/2026
Event: European Medicines Agency (EMA) and European Alliance of Associations for Rheumatology (EULAR) bilateral meeting
 New
02/03/2026
Page: Medical devices
 Updated
02/03/2026
Document: Report - Highlights of the 15th Industry Standing Group (ISG) meeting
 Updated
02/03/2026
Page: Non-clinical development and evaluation of microbiome-based medicinal products - Scientific guideline
 New
02/03/2026
Document: Draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products
 New
02/03/2026
Medicine: Nemluvio nemolizumab
Updated
02/03/2026
Medicine: Azomyr desloratadine
Updated
02/03/2026
Event: Electronic application form (eAF) Q&A clinic
 Updated
02/03/2026
Medicine: Nexium Control esomeprazole
Updated
02/03/2026
Medicine: Xbonzy denosumab
Updated
02/03/2026
Page: Quality of medicines: questions and answers - Part 1
 Updated
02/03/2026
Event: Healthcare Professionals' Working Party (HCPWP) plenary meeting February 2026
 Updated
02/03/2026
Event: Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
 Updated