What they are

EMA’s scientific guidelines are prepared by the CHMP with EU Member State regulators to give a harmonised reading of quality, safety, and efficacy requirements. They are not legally binding, but EMA “strongly encourages” applicants to follow them, and any deviation must be fully justified in the application.

The compilation follows the CTD structure: quality, non-clinical, clinical efficacy and safety by therapeutic area, multidisciplinary topics, and ICH guidelines. A guideline typically moves through concept paper, draft, overview of comments, and adopted guideline. Only adopted guidelines become part of EudraLex Volume 3, and each carries an effective date. EMA also publishes GMP, GCP, and pharmacovigilance (GVP) guidance and Q&A.

What is new: EMA and AI

EMA has become one of the most active regulators on AI, and its documents are useful reference points for any AI knowledge base:

  • Reflection paper on AI in the medicinal product lifecycle, adopted by CHMP and CVMP in September 2024.
  • Guiding principles for large language models, first published with HMA in September 2024 and updated regularly.
  • First AI methodology qualification opinion (AIM-NASH), March 2025.
  • EMA and FDA guiding principles of good AI practice in drug development, ten joint principles published 14 January 2026.
  • AI Observatory report 2025, published 4 June 2026.

Where to find it

  • EMA scientific guidelines pages, organized by the categories above.
  • EMA AI page, collecting the AI documents listed.
  • EudraLex Volume 3 on the Commission site for adopted guidelines.

Reuse terms

EMA’s legal notice allows public information to be reproduced and distributed, in whole or in part, in any format, for non-commercial and commercial purposes, “provided that EMA is always acknowledged as the source of the material” in each copy. Exclusions:

  • Third-party content needs the rightholder’s permission.
  • Photos and other materials may not be EMA’s copyright.
  • The EMA logo needs prior written permission.
  • The notice does not address AI or text and data mining specifically, so the general terms are what you rely on.

Using EMA guidelines in AI and RAG

  1. Record the stage (concept paper, draft, adopted) and effective date for every guideline.
  2. Keep “EMA” as a source field so attribution can be added to every output automatically.
  3. Flag embedded third-party material, such as reproduced standards or journal figures.
  4. Link ICH guidelines to the ICH originals (see the ICH article) and note which version EMA adopted.
  5. Use EMA’s LLM guiding principles as an internal policy check: safe data input, cross-checking outputs, and knowing whom to consult.
  6. Watch EMA consultation pages for drafts that may replace current guidelines.

Common mistakes

  • Treating a draft or concept paper as the current expectation.
  • Removing the EMA source acknowledgement when chunks are quoted.
  • Assuming every figure in an EMA PDF is EMA’s copyright.
  • Ignoring that deviations must be justified, not simply allowed.

Checklist

  • Stage and effective date recorded
  • EMA attribution in every output
  • Third-party content flagged
  • ICH versions cross-referenced
  • Internal AI use checked against EMA LLM principles
  • Consultation pages monitored

How AskDona helps

AskDona compares your Module 3 sections, clinical overviews, and PV system documents with the EMA guidelines you select, showing the guideline, stage, and effective date behind each finding. EMA attribution travels with every cited passage.

Run a sample EMA guideline gap check

AskDona shows the evidence; your regulatory team decides.

Editor’s note. This article is general information, not legal advice. The “conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.

FAQ

Are EMA guidelines legally binding? No, but EMA strongly encourages following them, and deviations must be justified.

Can I reuse EMA content commercially? Yes, if EMA is acknowledged as the source in each copy. Third-party content and the logo are excluded.

What did EMA and FDA publish on AI in 2026? Ten joint guiding principles of good AI practice in drug development, published 14 January 2026.

Which EMA guidelines are in EudraLex? Adopted scientific guidelines form part of EudraLex Volume 3.

References

All pages opened and checked by October 26, 2026.

SourceWhat it supports
EMA: Scientific guidelinesStatus, organization, lifecycle, deviations must be justified
EMA: Artificial intelligence (updated Aug 14, 2026)Reflection paper, LLM principles, EMA/FDA principles, AI Observatory
EMA legal noticeReproduction with source acknowledgement, commercial use, exclusions
European Commission: EudraLexVolume 3 as scientific guidelines