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EMA publishes its scientific guidelines, concept papers, committee documents and withdrawn applications as they happen.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.
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.
All recent EMA documents
Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda
List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1
Minutes - HMA-EMA joint Network Data Steering Group meeting - 16 June 2026
Twelve 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 C…
Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)
Human medicines European public assessment report (EPAR): Azacitidine Adienne, azacitidine, Status: Application withdrawn
Minutes – Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 12 June 2026
Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
Agenda - Network Data Steering Group and industry stakeholders annual meeting
Summary report - Network Data Steering Group and industry stakeholders annual meeting
Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1
Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1
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
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
Withdrawn application: Dupixent, 24/06/2026
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1
Agenda - PDCO agenda of the 21-24 July 2026 meeting
Minutes of the HMPC meeting 4-6 May 2026
Direct healthcare professional communication (DHPC) : Tavneos (avacopan) – recommendation for revocation of the marketing authorisation in the EU due to unfavourable benefit-risk balance
CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Bexatil for the reduction of hyperglycaemia in cats…
Questions and answers on Article 20 non-pharmacovigilance procedures
Questions and answers on Article 29(4) referral procedures
Questions and answers on Article 13 referral procedures
Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products
List of substances and products subject to worksharing for signal management
Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today…, Enabling innovation is central to our pub…
Questions and answers on Article 30 referral procedures
Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum
Questions and answers on Article 31 non-pharmacovigilance referrals
Brussels, 14 July 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Dear Ms Jerkovic, dear…
Agenda of the COMP Meeting 14-16 July 2026
Agenda of the CVMP meeting 14-16 July 2026
Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Pre-notification check for type IB Variations
Guidance on good manufacturing practice and good distribution practice: Questions and answers
Guidance for applicants for the preparation of the precise scope section of the variation application form
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Minutes of the COMP meeting 11-12 May 2026
Agenda - EMA/HMA European platform for regulatory science research platform meeting
PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata Desogestrel- and etonogestrel-…, Agenda Agenda of the PRAC meetin…
Agenda - EnprEMA Coordinating Group meeting, April 2026
Minutes - Enpr-EMA Coordinating Group meeting, April 2026
Agenda - Sixteenth industry stakeholder platform on research and development support
EMA risk management information day
EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased…
Qualification of novel methodologies for medicinal product development: guidance to applicants
Agenda of the PRAC meeting 6-9 July 2026
Agenda of the HMPC meeting 6-8 July 2026
EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their…, Advancing developments in women’s health…
List of centrally authorised products with safety-related changes to the product information
Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
Concept paper on the revision of the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease
Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)
Withdrawn application: BiResp Spiromax, 27/04/2026
Withdrawn application: DuoResp Spiromax, 27/04/2026
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.
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