[ 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EMA publishes its scientific guidelines, concept papers, committee documents and withdrawn applications as they happen.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.

104
Documents tracked
11
Open for comment
11 Sept 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.

11 Sept 2026Draft guideline
Draft guideline on the investigation of interactions in the gastrointestinal tract
10 Sept 2026Draft guideline
Draft guideline on clinical investigation of medicinal products for the treatment of migraine and cluster headache - Revision 2
17 Aug 2026
Draft data standards framework
12 Aug 2026
Draft qualification opinion for the Big Multiple Sclerosis Data (BMSD) network
30 Jul 2026Concept paper
Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases
27 Jul 2026Draft guideline
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1
24 Jul 2026Concept paper
Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
24 Jul 2026Concept paper
Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)
Committee document · 35Guideline · 9Concept paper · 6Withdrawn application · 5Draft guideline · 3Inspection · 3

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.

New to GxP? Start with Navigator →
60 EMA updates
Newest first
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

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.