GxPlex

FDA/EMA AI principles

Guiding Principles of Good AI Practice in Drug Development

not yet verified

Last verified: not yet verified Last observed: SHA-256: b970b2dbbcaab813ccd5dcae78672b2cd3653749fa38eff05cdfc43cfa135b02

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Resolution: direct document

Authority
US Food and Drug Administration and European Medicines Agency
Jurisdiction
International
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
weekly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) ema.europa.eu
Topics
artificial intelligence · drug development · manufacturing · international harmonisation

Current status#

No status has been confirmed against the primary source. Recorded as unknown rather than estimated.

Observation history#

First observed 31 July 2026. Last observed 3 August 2026. 13 observation(s) recorded.

13 of those returned a document to a standard HTTP client and produced a content hash.

No change to the retrieved text has been detected since observation began.

What is not known#

The source was retrieved, but no phrase stating a regulatory status was found near a mention of this instrument.

Sources#

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. Guiding Principles of Good AI Practice in Drug Development [instrument record]. Observed 3 August 2026. https://gxplex.com/instrument/fda-ema-good-ai-practice Primary source: https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf

BibTeX

@misc{gxplexinstrumentfdaemagoodaipracti,
  author       = {{GxPlex}},
  title        = {{Guiding Principles of Good AI Practice in Drug Development}},
  year         = {2026},
  note         = {instrument record, observed 3 August 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-ema-good-ai-practice}},
  urldate      = {2026-08-03},
  url          = {https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf}
}

APA

GxPlex. (2026). Guiding Principles of Good AI Practice in Drug Development [instrument record]. Retrieved 3 August 2026, from https://gxplex.com/instrument/fda-ema-good-ai-practice

Observation history

Observed on 13 occasion(s) since 2026-07-31. 13 produced a content hash.

·············

One mark per observation, oldest first. · unchanged · ! content changed · ~ fetched but rendered client-side, no hash · × could not be fetched, no hash.

First observed
2026-07-31
Last observed
2026-08-03 (HTTP 200)
Fetch method
direct
Current hash
b970b2dbbcaab813ccd5dcae78672b2cd3653749fa38eff05cdfc43cfa135b02

Subject and class (as stated)

The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.

This document's title states no subject term this archive matches. That is a fact about the reading, not a subject it lacks — it is filed under no self-stated subject.

This document does not call itself a regulation, a guidance or a standard, so no class is recorded. It is filed under no self-stated class.

Sources