{
  "version": "https://jsonfeed.org/version/1.1",
  "title": "Preclari Intelligence",
  "home_page_url": "https://preclari.com/intelligence/",
  "feed_url": "https://preclari.com/intelligence/feed.json",
  "description": "Regulatory change rendered as machine-actionable compliance preflight intelligence for AI workflows in regulated industries.",
  "language": "en-GB",
  "authors": [
    {
      "name": "Preclari",
      "url": "https://preclari.com"
    }
  ],
  "_license": "https://creativecommons.org/licenses/by/4.0/",
  "items": [
    {
      "id": "https://preclari.com/intelligence/ai-act-high-risk-timeline-pharma/",
      "url": "https://preclari.com/intelligence/ai-act-high-risk-timeline-pharma/",
      "title": "The EU AI Act's high-risk deadline is still 2 August 2026. A proposed deferral has not changed what you must hold.",
      "summary": "A provisional EU agreement in May 2026 proposes to defer the AI Act's high-risk obligations to 2027 and 2028. It is not yet law: the enacted date, 2 August 2026, still binds. Whichever date applies, the same record a preflight produces answers both the AI Act and the draft GMP Annex 22.",
      "date_published": "2026-06-11T00:00:00.000Z",
      "authors": [
        {
          "name": "Preclari"
        }
      ],
      "tags": [
        "ai-governance",
        "eu-ai-act",
        "digital-omnibus",
        "high-risk",
        "pharma",
        "preflight"
      ],
      "_preflight": {
        "authority": "European Parliament and Council of the EU",
        "jurisdiction": "EU",
        "instrument": "EU AI Act (Regulation (EU) 2024/1689), with a proposed amendment by the Digital Omnibus on AI (COM(2025) 836)",
        "clause": "Arts 9-15 (high-risk requirements), Art 50 (transparency), Art 113 (application dates); Annexes I and III",
        "changeType": "revision",
        "status": {
          "stage": "in-force",
          "draftPublished": "2025-11-19",
          "expectedAdoption": "Digital Omnibus (COM(2025) 836) is a provisional political agreement (trilogue 6-7 May 2026); formal adoption pending Parliament plenary vote, Council adoption, and Official Journal publication, expected before 2 August 2026",
          "expectedEnforcement": "Enacted: high-risk applies 2 August 2026 (Reg (EU) 2024/1689, Art 113). Proposed deferral, not yet law: Annex III to 2 December 2027; Annex I to 2 August 2028"
        },
        "verticals": [
          "pharma-gmp",
          "medtech",
          "cross"
        ],
        "aiRelevance": "The AI Act sets horizontal obligations for AI by risk class. Most pharma manufacturing AI is not Annex III high-risk, but AI that is or sits inside a medical device is Annex I high-risk, and the Act's transparency duties apply broadly from 2 August 2026. The requirements it places on high-risk systems are the same evidence a regulated AI workflow should hold anyway.",
        "preflightImplication": "The AI Act's high-risk articles (risk management, data governance, technical documentation, record-keeping, human oversight, accuracy and robustness) and the draft GMP Annex 22 ask for the same core record. A preflight that produces intended use, data provenance, validation evidence, a human-review gate, and monitoring satisfies the common core of both, whichever date binds first.",
        "corpusAnchors": [
          "eu-ai-act-2024-1689"
        ],
        "source": {
          "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2025:836:FIN",
          "publisher": "European Commission",
          "reproductionBasis": "reference-only"
        },
        "verification": {
          "state": "verified",
          "reviewedAt": "2026-06-11"
        }
      }
    },
    {
      "id": "https://preclari.com/intelligence/annex-22-ai-gmp-draft/",
      "url": "https://preclari.com/intelligence/annex-22-ai-gmp-draft/",
      "title": "The EU has drafted the first GMP rules for AI. A preflight reads them as a checklist.",
      "summary": "The European Commission's draft Annex 22 sets the first GMP expectations for artificial intelligence in medicine manufacturing. The comment period closed in October 2025 and formal adoption is expected this year. Almost every requirement it names is something you can check before the rule lands.",
      "date_published": "2026-06-11T00:00:00.000Z",
      "authors": [
        {
          "name": "Preclari"
        }
      ],
      "tags": [
        "ai-governance",
        "gmp",
        "annex-22",
        "annex-11",
        "eudralex",
        "preflight",
        "regulated-ai"
      ],
      "_preflight": {
        "authority": "European Commission (DG SANTE) / EMA GMDP Inspectors' Working Group",
        "jurisdiction": "EU",
        "instrument": "EudraLex Volume 4, Annex 22 (Artificial Intelligence)",
        "clause": null,
        "changeType": "new-draft",
        "status": {
          "stage": "consultation-closed",
          "draftPublished": "2025-07-07",
          "commentDeadline": "2025-10-07",
          "expectedAdoption": "2026",
          "expectedEnforcement": "2027-2028"
        },
        "verticals": [
          "pharma-gmp"
        ],
        "aiRelevance": "Annex 22 is the first GMP text written specifically for AI and machine-learning systems that affect product quality, patient safety, or data integrity. It tells you what regulators will expect of any AI workflow you put near a GMP process.",
        "preflightImplication": "Each requirement Annex 22 names maps to a checkable assertion: intended use declared, training-data provenance recorded, validation evidence present, a human-review gate defined, ongoing monitoring in place. A preflight can assert all of these before a workflow runs.",
        "corpusAnchors": [
          "eu-gmp-annex-11",
          "pics-pi-011-3"
        ],
        "source": {
          "url": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en",
          "publisher": "European Commission, Directorate-General for Health and Food Safety",
          "reproductionBasis": "reference-only"
        },
        "verification": {
          "state": "verified",
          "reviewedAt": "2026-06-11"
        }
      }
    }
  ]
}