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Latest / Health and life sciences

PolicyHealthEUConfirmed

EMA consults on how AI may be used across a medicine’s lifecycle

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Source: European Medicines Agency

The European Medicines Agency published a draft reflection paper on AI in the medicinal product lifecycle for consultation from 19 July to 31 December 2023. It covers drug discovery, non-clinical work, clinical trials, precision medicine, product information, manufacturing and post-authorisation safety monitoring, and was adopted for release by the CHMP on 10 July and CVMP on 13 July.

Why it matters

Drug developers using AI in trials or manufacturing in the EU learned what the regulator expects to see when AI outputs feed into evidence for a marketing authorisation.

When
19 Jul 2023
ID
WTA-N-2023-0162
Who
European Medicines Agency

Summary by wheresthe.ai, from European Medicines Agency. Checked against the source on 9 Oct 2026.

Read the original at European Medicines Agency

Source copy: download the source PDF as saved on 18 Oct 2026 (PDF). Document the source offers: the source PDF. Also held by the Internet Archive.

Next stop on this Storyline: What happened nextFDA and EMA issue ten joint principles for AI in drug development

Data to measure this

Compare the years before 2023 with the years since in these series.

  • ETO Country AI Activity MetricsEmerging Technology Observatory, CSET (Georgetown)AI research articles and citations, AI patents and AI equity investment by country, year and field.monthly · download · CSV
  • WIPO: patent trends in generative AIWorld Intellectual Property OrganizationPublished generative-AI patent families by country, applicant, data type and model type.Years: 2014-2025 · one-off · report only · PDF · Covers before and after
  • OECD.AI: AI research publicationsOECD.AI (data from OpenAlex)AI publications and citations by country and institution, per capita and by quality tier.live · query tool
  • WIPO IP Statistics Data CenterWorld Intellectual Property OrganizationPatent, trademark and design indicators worldwide, with patents by class and 35 technology fields.annual · query tool

All data for European Union

Cite this story

WTA-N-2023-0162: “EMA consults on how AI may be used across a medicine’s lifecycle.” wheresthe.ai, 19 Jul 2023. https://wheresthe.ai/d/eu-ema-ai-medicines-reflection-paper-2023-07/ (source: European Medicines Agency).

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