[ EMA · EUROPEAN MEDICINES AGENCY ]

What Europe is about to require — while you can still comment on it.

EMA publishes its scientific guidelines, concept papers, committee documents and withdrawn applications as they happen. The most useful of these are the ones still open for public comment — the window in which a requirement can still be influenced, and the point at which most organisations first learn a change is coming far too late.

200
Documents tracked
24
Open for comment
Oct 19, 2026
Most recent

OPEN FOR PUBLIC COMMENT

EMA is currently consulting on these. Check the closing date on EMA’s page before relying on the window still being open — SPEQ tracks that a consultation was opened, not when it shuts.

Oct 19, 2026
Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports
Oct 19, 2026Reflection paper
Reflection paper on methodological aspects in confirmatory platform trials
Oct 19, 2026Concept paper
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)
Oct 16, 2026Concept paper
Concept paper on clinical trials in recipients of kidney transplantation
Oct 15, 2026Reflection paper
Draft reflection paper on the investigation of drug interactions of herbal medicinal products
Oct 8, 2026Draft guideline
Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products
Sep 24, 2026Draft guideline
Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
Sep 24, 2026Draft guideline
Draft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
Committee document · 72Guideline · 12Withdrawn application · 11Concept paper · 10Draft guideline · 9Inspection · 8

All recent EMA documents

How to use this library

Start with Type when you know what you are after — a public consultation is the only time-limited thing here, a guideline is settled expectation. Rows open EMA’s own page: this feed links out rather than to a SPEQ record.

SPEQ reproduces EMA publication metadata as published and adds no interpretation. Type is SPEQ’s classification of the document, not EMA’s — a blank type means SPEQ could not classify it, and is never a guess. The feed a document arrived on is not rendered as its type, because EMA’s feed labels do not describe their contents.

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200 EMA updates
Newest first
2026-10-16Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.Rasonque (daraxonrasib)…, CHMP statistics Key figures from the October 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Foundayo International non-proprietary name (INN) orforglipron Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of…, Rasonque INN daraxonrasib Marketing authorisation applicant Revolution Medicines Netherlands B.V. Therapeutic indication Treatment of metastatic pancreatic…, Yuviwel INN navepegritide Marketing authorisation applicant Ascendis Pharma Growth Disorders A/S Therapeutic indication Treatment of achondroplasia in…, Positive recommendations on new biosimilar medicines, Fovlussea INN ranibizumab Marketing authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of neovascular (wet) age-related macular…, Neuzafy INN filgrastim Marketing authorisation applicant CuraTeQ Biologics (Malta) Limited Therapeutic indication Treatment of neutropenia in adults and…, Positive recommendation on new hybrid medicine, Kizfizo INN temozolomide Marketing authorisation applicant Orphelia Pharma Therapeutic indication Treatment of adults with glioblastoma multiforme and…, Positive recommendations on extensions of therapeutic indications , Kyinsu INN insulin icodec / semaglutide Marketing authorisation holder Novo Nordisk A/S More information Kyinsu: pending EC decision, Pandemic influenza vaccine H5N1 AstraZeneca Common name pandemic influenza vaccine (H5N1) (live attenuated, nasal) Marketing authorisation holder AstraZeneca AB…, Talvey INN talquetamab  Marketing authorisation holder Janssen-Cilag International N.V. More information Talvey: pending EC decision Orphan…, Tryngolza INN olezarsen Marketing authorisation holder Swedish OCommittee document
2026-10-02Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 OctoberAt its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 September - 1 October 2026Draft Reference Number: EMA/PRAC/204838/2026…, PRAC statistics: October 2026 Monthly figures for PRAC outcomes based on the draft agenda. © European Medicines Agency, PRAC statistics:…, Ongoing referrals Procedure: Parenteral iron-containing medicinal products - referral, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…Committee document
2026-09-18Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 202612 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.The committee recommended…, CHMP statistics Key figures from the September 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency, CHMP statistics:…, Positive recommendations on new medicines, Frehemgo International non-proprietary name (INN) denecimig Marketing authorisation applicant Novo Nordisk A/S Therapeutic indication Treatment of prophylaxis…, Gevalka INN ensartinib Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication The treatment of adult patients with…, Klygefa INN gefurulimab Marketing authorisation applicant Alexion Europe Therapeutic indication Treatment of adult patients with generalised myasthenia gravis…, Lifyorli INN relacorilant Marketing authorisation applicant Corcept Therapeutics Netherlands B.V Therapeutic indication Lifyorli in combination with nab-…, Povofortay INN povorcitinib Marketing authorisation applicant Incyte Biosciences Distribution B.V Therapeutic indication Treatment of active moderate to…, Sepalna INN senaparib  Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication Maintenance treatment of advanced…, VaxRabeo INN Rabies vaccine (inactivated) for human use Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Pre-exposure and…, Zeydovio INN glepaglutide Therapeutic indication Treatment of adults with Short Bowel Syndrome More information Zeydovio : pending EC decision, Positive recommendation on new biosimilar medicine, Adcomfo INN omalizumab Marketing authorisation applicant Advanz Pharma Limited Therapeutic indication Treatment of asthma, chronic rhinosinusitis with nasal…, Pebrilzo INN pertuzumab Marketing authorisation applicant Biosimilar Collaborations Ireland Limited Therapeutic indication Treatment of breast cancer in…, PositCommittee document
2026-09-04Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agenda of the PRAC meeting 31 August - 3 September 2026Draft Reference Number: EMA/PRAC/164465/2026 Corr.1…, PRAC statistics: September 2026 Monthly figures for PRAC outcomes based on the draft agenda. @ European Medicines Agency, PRAC statistics:…, Ongoing referrals Procedure: Parenteral iron-containing medicinal products - referral, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…Committee document
2026-07-24Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026Twelve new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended twelve medicines for approval at its July 2026 meeting.The committee…, CHMP statistics Key figures from the July 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Evlarco International non-proprietary name (INN) obicetrapib / ezetimibe  Marketing authorisation applicant A. Menarini International Licensing S.A.…, Icotyde INN icotrokinra hydrochloride  Marketing authorisation applicant Janssen-Cilag International N.V. Therapeutic indication Treatment of moderate to…, Lynavoy INN linerixibat Marketing authorisation applicant Glaxosmithkline Trading Services Limited Therapeutic indication Treatment of cholestatic pruritus in…, Lyrokaul INN lerodalcibep Marketing authorisation applicant LIB Therapeutics B.V. Therapeutic indication Treatment of adults with primary…, Nezglyal INN leriglitazone  Marketing authorisation applicant Minoryx Therapeutics S.L. Therapeutic indication Treatment of cerebral…, Susvimo INN ranibizumab Marketing authorisation applicant Roche Registration GmbH Therapeutic indication Treatment of adults with neovascular (wet) age-…, Ubeslo INN obicetrapib Marketing authorisation applicant A. Menarini International Licensing S.A. Therapeutic indication Treatment of primary…, Zokovea INN ensitrelvir Marketing authorisation applicant Shionogi B.V. Therapeutic indication Post-exposure prophylaxis of COVID-19 More information…, Positive recommendation on new biosimilar medicine, Cavoley INN pegfilgrastim Marketing authorisation applicant CuraTeQ Biologics s.r.o Therapeutic indication Reduction of neutropenia in adults More…, Positive recommendations on new generic medicines, Riociguat Accord INN riociguat Marketing authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of Chronic thromboembolic…, Ruxolitinib ViatCommittee document

Every count on this page is derived from the ema_updates table at render — none is a literal. Follow each link for EMA’s authoritative page.

Source: the European Medicines Agency’s own RSS feeds (scientific guidelines, regulatory and procedural guidelines, public consultations, news, agendas and minutes, withdrawn applications),refreshed daily. Titles, dates and links are EMA records reproduced as published. The document-type label is SPEQ’s reading of each title and is omitted where undetermined. SPEQ is not affiliated with EMA. The archive builds forward from the first ingest.