Published document record

EMA/HMA principles for regulatory use of LLMs

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EMA/HMA principles for regulatory use of LLMs. First published guiding principles.
Source: European Medicines Agency. Retrieved 2026-09-10.
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Unmodified source PDF. Source attribution and original notices are retained; see the source reuse terms. Source reuse terms. The database metadata licence does not replace these terms.
SHA-256: a624cf53d374dc7b7d78eae92b5e783f36b82099e7fb82ca0f7238e81a45f24a

Official metadata

Official title: Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities
Document type: Guidelines
Document date: 2024-08-29
Document date kind: Document issue
Document-date evidence: European Medicines Agency · PDF p.1: 29 August 2024. — Exact printed document issue date, distinct from publication.
Publication date: 2024-09-05
Publication-date evidence: European Medicines Agency · Related documents, exact guiding-principles entry: First published 05/09/2024; release header 5 September 2024. — Official release evidence for this independently citable text.
Version label: First published guiding principles
Legal status: Non binding
Legal-status evidence: European Medicines Agency · Scope and principles; recommendations for good practice. — Institutional research or high-level guidance, not a binding legal instrument.
Language: en

Research classifications

These are researcher classifications used to organise and analyse the corpus; they are not official EU metadata.

Record level

Principal

Version status

Final

Temporal collection

Contemporary EU AI policy

Relevance class

Direct AI relevance

Policy stage

Implementation

Corpus tier

Directly related

Sectors

Policy membership

Classification evidence

Relevance class: Direct AI relevance · European Medicines Agency · PDF p.2 section 1, pp.6-10 sections 5-6: responsible LLM use in regulatory science, medicines regulation and regulatory-authority administration. — AI is a substantive policy or sectoral subject throughout the cited passages.
Sector tags: Health · European Medicines Agency · PDF p.2 section 1, pp.6-10 sections 5-6: responsible LLM use in regulatory science, medicines regulation and regulatory-authority administration. — Positive researcher classification based on the stated substantive scope.
Sector tags: Public administration · European Medicines Agency · PDF p.2 section 1, pp.6-10 sections 5-6: responsible LLM use in regulatory science, medicines regulation and regulatory-authority administration. — Positive researcher classification based on the stated substantive scope.
Sector tags: Research and innovation · European Medicines Agency · PDF p.2 section 1, pp.6-10 sections 5-6: responsible LLM use in regulatory science, medicines regulation and regulatory-authority administration. — Positive researcher classification based on the stated substantive scope.
Provenance tags: Authored by an EU agency or body · European Medicines Agency · Corporate attribution and substantive institutional account. — Provenance reflects evidenced production or official publication; hosting is not itself authorship.
Provenance tags: Officially published · European Medicines Agency · Related documents, exact guiding-principles entry: First published 05/09/2024; release header 5 September 2024. — Provenance reflects evidenced production or official publication; hosting is not itself authorship.

Production provenance

Provenance tags

Named bibliographic authors

European Medicines Agency · European Medicines Agency · PDF p.1 corporate author credit.

Institutions and roles

European Medicines Agency · Author · role evidence · PDF p.1, European Medicines Agency corporate credit.
European Medicines Agency · Official host · role evidence · EMA release and linked English PDF.
European Medicines Agency · Publisher · role evidence · Release opening paragraph: EMA and HMA have published the principles.
Heads of Medicines Agencies · Publisher · role evidence · Release opening paragraph explicitly names HMA as co-publisher.

Official sources and identifiers

Official source · Publisher/host: European Medicines Agency
Official source · Publisher/host: European Medicines Agency

Research assessment

Inclusion rationale: PDF p.2 section 1, pp.6-10 sections 5-6: responsible LLM use in regulatory science, medicines regulation and regulatory-authority administration.
Researcher notes: EMA is the printed corporate author. The release identifies EMA and HMA as joint publishers; joint publication alone is not labelled joint authorship. The living-document description does not establish a later independently citable revision. At the initial review on 6 September 2026, concept coding and policy-group assignment were uncompleted. Concept tags were subsequently populated in the 7 September 2026 concept review. Broad policy-group membership was subsequently recorded on 12 September 2026. This editorial grouping does not establish a legal or procedural relationship.
Review status: verified

Relationships

No additional published relationships touch this record.

Verification

Expanded evidence review: Verified

Reviewed by: Yichen Hao
Evidence review date: 2026-09-06T22:52:47Z

The evidence review date is not a separate human sign-off date. Review credit and evidence-review actions

Last verified: 2026-09-06T22:52:47Z · AI-assisted evidence review. Fresh HTTP 200 capture, 203261 bytes, SHA-256 a624cf53d374dc7b7d78eae92b5e783f36b82099e7fb82ca0f7238e81a45f24a. PDF p.2 section 1, pp.6-10 sections 5-6: responsible LLM use in regulatory science, medicines regulation and regulatory-authority administration. Capture retained outside canonical data; no public archive guarantee. Exact receipt in candidate-health-finance-20260906 audit. PDF extraction recovered with pypdf after optional fitz module was unavailable.
Last verified: 2026-09-06T22:52:47Z · AI-assisted evidence review. Fresh HTTP 200 capture, 67689 bytes, SHA-256 052a350bd7c161947eb11e4bd05e03853da52c7d6748dac8544563ce712e8115. Related documents, exact guiding-principles entry: First published 05/09/2024; release header 5 September 2024. Capture retained outside canonical data; no public archive guarantee. Exact receipt in candidate-health-finance-20260906 audit. PDF extraction recovered with pypdf after optional fitz module was unavailable.

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