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    Pharma AI Tracker / Regulatory Guidance

    Pharma AI regulatory guidance

    This page lists what regulators and legislators have published about AI in pharma and GxP work. Each entry links to the official source and shows its status, key dates, and version history.

    The Tracker records company disclosures. This page records regulators' documents and how binding they are.

    13 documents from 7 issuers Last checked

    Checked weekly for new items; every entry re-checked monthly.

    European Commission and PIC/S

    Annex 22: Artificial Intelligence

    Draft, not final

    EU GMP annex EU GMP guideline

    Consultation draft (stakeholders consultation closed)

    Key dates

    Consultation opened
    Consultation closed

    Draft EU GMP annex on artificial intelligence, published for consultation by the European Commission with PIC/S. The consultation closed on October 7, 2025, no final text has been published, and the annex is not listed on the EudraLex Volume 4 page yet. An EMA workshop report says the drafting group has discussed changing the scope to allow dynamic or adaptive models, probabilistic models, and generative AI or LLMs.

    • GMP computerized systems
    • Manufacturing

    Hristos's reading

    For a GxP team, this is a draft signal of how EU GMP may treat AI models, not a final rule. The workshop report suggests the draft limits on dynamic models and generative AI are still under discussion.

    History, related documents and source excerpt

    Related documents

    What changed and when

    1. source for Annex 22: Artificial Intelligence

      Consultation closed

    2. source for Annex 22: Artificial Intelligence

      Consultation opened

      First published version.

    [...] the document does not apply to Generative AI and Large Language Models (LLM), and such models should not be used in critical GMP applications.

    Source: European Commission, ‘Annex 22: Artificial Intelligence,’ licensed under CC BY 4.0. No changes made.

    Annex 11: Computerised Systems

    Draft, not final

    EU GMP annex EU GMP guideline

    Consultation draft (stakeholders consultation closed)

    Key dates

    Consultation opened
    Consultation closed

    Draft revision of EU GMP Annex 11 on computerized systems, from the European Commission with PIC/S. The consultation closed on October 7, 2025, and no final text has been published. The draft text does not mention artificial intelligence, and it is listed because draft Annex 22 is written as additional guidance to Annex 11.

    • GMP computerized systems
    • Validation

    Hristos's reading

    Draft Annex 22 is written as additional guidance to Annex 11, so a GxP team reading the AI annex will likely read this beside it. This draft does not itself mention artificial intelligence.

    History, related documents and source excerpt

    Related documents

    What changed and when

    1. source for Annex 11: Computerised Systems

      Consultation closed

    2. source for Annex 11: Computerised Systems

      Consultation opened

      First published version.

    The revised guideline should clarify requirements and expectations from regulatory authorities, and remove ambiguity and inconsistencies.

    Source: European Commission, ‘Annex 11: Computerised Systems,’ licensed under CC BY 4.0. No changes made.

    Chapter 4: Documentation

    Draft, not final

    EU GMP chapter EU GMP guideline

    Consultation draft (stakeholders consultation closed)

    Key dates

    Consultation opened
    Consultation closed

    Draft revision of EU GMP Chapter 4 on documentation, from the European Commission with PIC/S. The consultation closed on October 7, 2025, and no final text has been published. The draft text places accountability for the integrity of records and data produced or processed with artificial intelligence on the regulated user.

    • Documentation and records
    • Data integrity

    Hristos's reading

    Where AI helps produce GMP records or data, this draft is the consultation text that puts integrity accountability on the regulated user. It is still a draft.

    History, related documents and source excerpt

    Related documents

    What changed and when

    1. source for Chapter 4: Documentation

      Consultation closed

    2. source for Chapter 4: Documentation

      Consultation opened

      First published version.

    The accountability for the integrity of documents, records or (raw) data produced or processed with artificial intelligence or any other automatic means (e.g. validation scripts) rests with the regulated user.

    Source: European Commission, ‘Chapter 4: Documentation,’ licensed under CC BY 4.0. No changes made.

    FDA

    Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

    Draft, not final

    Guidance Non-binding

    Draft Guidance (not for implementation)

    Key dates

    Issued
    Published
    (Federal Register notice)
    Target comment date
    (comments may be submitted at any time)

    Draft FDA guidance on using artificial intelligence to produce information that supports regulatory decisions on drug and biological products. It describes a risk-based framework for judging whether an AI model is credible for a defined context of use. It is still a draft, and a final version had not been published as of October 7, 2026.

    • AI in submissions
    • Model credibility

    Hristos's reading

    A team whose AI output may support a regulatory decision can read the draft for how FDA frames context of use and model risk. It remains a draft and is not for implementation.

    History, related documents and source excerpt

    Identifiers

    • FDA docket FDA-2024-D-4689
    • Federal Register document 2024-31542

    What changed and when

    1. source for Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

      Target comment date (comments may be submitted at any time)

    2. source for Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

      Published (Federal Register notice)

    3. source for Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

      Issued

      First published version.

    [...] a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model

    Source: U.S. Food and Drug Administration, ‘Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products,’ copied October 8, 2026.

    Computer Software Assurance for Production and Quality Management System Software

    Final

    Guidance Non-binding

    Key dates

    Issued

    Final, non-binding FDA guidance on computer software assurance for production and quality management system software. Its scope is software used as part of medical device production or the quality management system, and it sets no drug cGMP requirements. The February 2026 version names artificial intelligence and machine learning tools.

    • Validation
    • Manufacturing

    Hristos's reading

    Final, nonbinding FDA guidance for software used as part of medical device production or the quality management system. It does not set drug cGMP requirements. The February 2026 version names AI/ML tools.

    History, related documents and source excerpt

    Identifiers

    • FDA docket FDA-2022-D-0795

    What changed and when

    1. source for Computer Software Assurance for Production and Quality Management System Software v3

      Issued

      Reissued under a new title (Quality Management System Software). We have not compared the full texts. Whether the AI and machine learning wording was already in the September 2025 version was not checked.

    2. source for Computer Software Assurance for Production and Quality Management System Software v2

      Issued

      Issued as final guidance.

    3. source for Computer Software Assurance for Production and Quality Management System Software v1

      Target comment date

    4. source for Computer Software Assurance for Production and Quality Management System Software

      Published (Federal Register notice)

      First published version.

    [...] artificial intelligence/machine learning tools, and cloud computing when used as part of production or the quality management system.¹⁴

    Source: U.S. Food and Drug Administration, ‘Computer Software Assurance for Production and Quality Management System Software,’ copied October 8, 2026.

    Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products

    Published

    Discussion paper Not guidance

    Revised February 2025

    Key dates

    Revised

    FDA discussion paper on artificial intelligence and machine learning in the development of drug and biological products, from CDER with CBER and CDRH. It is not guidance. A version dated May 2023 was revised in February 2025, and the two texts have not been compared for this entry.

    • Clinical development
    • Pharmacovigilance
    • Manufacturing

    Hristos's reading

    The February 2025 text is the later published version of a discussion paper, not a guidance to implement.

    History, related documents and source excerpt

    What changed and when

    1. source for Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products v2

      Revised

      Revised version. We have not compared it with the May 2023 version.

    2. source for Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products v1

      Published

      First published version.

    [...] is publishing this document to facilitate a discussion with stakeholders on the use of artificial intelligence (AI)¹ and machine learning (ML)² in drug development,³,⁴

    Source: U.S. Food and Drug Administration, ‘Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products,’ copied October 8, 2026.

    Artificial Intelligence in Drug Manufacturing

    Published

    Discussion paper Not guidance

    Discussion paper; comment period closed

    Key dates

    Published
    (Federal Register notice)
    Comment period closed
    (initial comment period)
    Comment period reopened
    (Federal Register notice)
    Comment period closed
    (reopened comment period, final close)

    FDA discussion paper on artificial intelligence in drug manufacturing, from CDER. It is not guidance. A Federal Register notice published it on March 1, 2023, and the first comment period closed on May 1, 2023. FDA reopened the comment period on September 27, 2023, and it closed on November 27, 2023.

    • Manufacturing

    Hristos's reading

    Manufacturing teams may read this as an early FDA discussion of AI in drug manufacturing. It is not guidance. The initial deadline was May 1, 2023; FDA reopened the docket on September 27, 2023, and closed comments on November 27, 2023.

    History, related documents and source excerpt

    Identifiers

    • FDA docket FDA-2023-N-0487
    • Federal Register document 2023-04206
    • Federal Register document 2023-20902

    What changed and when

    1. source for Artificial Intelligence in Drug Manufacturing

      Comment period closed (reopened comment period, final close)

    2. source for Artificial Intelligence in Drug Manufacturing

      Comment period reopened (Federal Register notice)

    3. source for Artificial Intelligence in Drug Manufacturing

      Comment period closed (initial comment period)

    4. source for Artificial Intelligence in Drug Manufacturing

      Published (Federal Register notice)

      First published version.

    [...] areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts

    Source: U.S. Food and Drug Administration, ‘Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments,’ copied October 8, 2026.

    EMA and FDA

    Guiding principles of good AI practice in drug development

    Published

    Joint principles Non-binding

    Key dates

    Published
    (EMA news item; document dated January 2026)

    Joint EMA and FDA principles of good AI practice in drug development, published as ten principles. They are non-binding. EMA published them on January 14, 2026, and the document is dated January 2026.

    • Governance principles
    • Clinical development

    Hristos's reading

    These principles offer a shared EMA and FDA vocabulary for AI in drug development, including manufacturing. They do not set a binding requirement.

    History, related documents and source excerpt

    What changed and when

    1. source for Guiding principles of good AI practice in drug development

      Published (EMA news item; document dated January 2026)

      First published version.

    AI technologies adhere to relevant legal, ethical, technical, scientific, cybersecurity, and regulatory standards, including Good Practices (GxP).

    Source: European Medicines Agency, ‘Guiding principles of good AI practice in drug development,’ accessed October 2026.

    EMA

    Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

    Final

    Reflection paper Non-binding

    Key dates

    Adopted
    (EMA AI page says adopted September 2024)
    Published

    EMA reflection paper on the use of artificial intelligence across the medicinal product lifecycle. It is final and non-binding. A draft was published for consultation in 2023, and the final text was published on September 30, 2024.

    • Clinical development
    • Pharmacovigilance

    Hristos's reading

    A GxP team can read this as EMA's framing of AI from early development through later lifecycle steps. It is a reflection paper, not a binding guideline.

    History, related documents and source excerpt

    Identifiers

    • EMA reference EMA/CHMP/CVMP/83833/2023

    What changed and when

    1. source for Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle v2

      Published

    2. source for Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

      Adopted (EMA AI page says adopted September 2024)

      Final version published after the public consultation. EMA published an overview of the comments received. We have not compared the draft and final texts.

    3. source for Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle v1

      Consultation closed

    4. source for Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

      Published

      First published version.

    5. source for Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

      Consultation opened

    This paper reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.

    Source: European Medicines Agency, ‘Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle,’ accessed October 2026.

    European Parliament and Council of the EU

    Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)

    Known as the Artificial Intelligence Act (AI Act).

    In effect

    EU regulation Binding law

    Key dates

    Latest consolidated text
    (includes Regulation (EU) 2026/1744, which entered into force that day)
    Applies from
    (high-risk AI systems under Article 6(2) and Annex III, as amended)
    Applies from
    (high-risk AI systems under Article 6(1) and Annex I, as amended)

    Regulation (EU) 2024/1689, the Artificial Intelligence Act, is binding EU law. It entered into force on August 1, 2024, and generally applies from August 2, 2026, with some provisions applying from February 2, 2025, and August 2, 2025. Regulation (EU) 2026/1744 later moved the application dates for high-risk AI systems to December 2, 2027, under Article 6(2) and Annex III, and to August 2, 2028, under Article 6(1) and Annex I. The latest consolidated text is dated July 27, 2026. Whether a pharma AI system is high-risk depends on its intended purpose and Article 6, including Annex I as well as Annex III, so each use case is assessed separately.

    • AI Act obligations

    Hristos's reading

    High-risk status is not one answer for every pharma AI system. It depends on the intended purpose of each system under Article 6, including Annex I and Annex III.

    History, related documents and source excerpt

    Related documents

    What changed and when

    1. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance) v2

      Applies from (high-risk AI systems under Article 6(1) and Annex I, as amended)

    2. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)

      Applies from (high-risk AI systems under Article 6(2) and Annex III, as amended)

    3. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance) v1

      Applies from (general date of application)

    4. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance) v2

      Latest consolidated text (includes Regulation (EU) 2026/1744, which entered into force that day)

      Regulation (EU) 2026/1744 moved the application dates for high-risk AI systems: December 2, 2027, for systems under Article 6(2) and Annex III, and August 2, 2028, for Annex I.

    5. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance) v1

      Applies from (second staged provisions)

    6. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)

      Applies from (first staged provisions)

    7. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)

      Entered into force

    8. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)

      Published (Official Journal)

    9. source for Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance)

      Signed

      First published version.

    Regulation (EU) 2024/1689 entered into force on 1 August 2024.

    Source: European Parliament and Council of the EU, 'Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance),' Official Journal of the European Union, Publications Office of the European Union. © European Union. Reuse authorised under Decision 2011/833/EU.

    Regulation (EU) 2026/1744 of the European Parliament and of the Council of 8 July 2026 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) (Text with EEA relevance)

    In effect

    EU amending regulation Binding law

    Key dates

    Signed
    Published
    (Official Journal)
    Entered into force

    Regulation (EU) 2026/1744 is a binding EU law that amends the Artificial Intelligence Act. It entered into force on July 27, 2026. It moves the application dates for high-risk AI systems to December 2, 2027, for systems under Article 6(2) and Annex III, and to August 2, 2028, for Annex I.

    • AI Act obligations

    Hristos's reading

    The date change is the part most likely to affect planning for a high-risk pharma AI system. This entry records that change and does not try to restate the whole amending act.

    History, related documents and source excerpt

    Related documents

    What changed and when

    1. source for Regulation (EU) 2026/1744 of the European Parliament and of the Council of 8 July 2026 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) (Text with EEA relevance)

      Entered into force

    2. source for Regulation (EU) 2026/1744 of the European Parliament and of the Council of 8 July 2026 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) (Text with EEA relevance)

      Published (Official Journal)

    3. source for Regulation (EU) 2026/1744 of the European Parliament and of the Council of 8 July 2026 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) (Text with EEA relevance)

      Signed

      First published version.

    ICH

    M15 General Principles for Model-Informed Drug Development

    Final

    ICH guideline Non-binding

    ICH Step 4

    Key dates

    Adopted
    (ICH Step 4)
    Effective
    (EU: comes into effect, per EMA)

    Final, non-binding ICH guideline on general principles for model-informed drug development. It names artificial intelligence and machine learning as one of the modeling methods in scope. It is not an AI-specific guideline. FDA issued it in the US as final, non-binding guidance in June 2026 (docket FDA-2024-D-5580).

    • Model credibility
    • Clinical development

    Hristos's reading

    Model-informed work that uses machine learning may sit inside this guideline. It is a general guideline on model-informed drug development, not an AI-specific one.

    History, related documents and source excerpt

    Identifiers

    • ICH code M15

    What changed and when

    1. source for M15 General Principles for Model-Informed Drug Development v2

      Effective (EU: comes into effect, per EMA)

    2. source for M15 General Principles for Model-Informed Drug Development

      Adopted (ICH Step 4)

      Adopted as final (Step 4). We have not compared the Step 2 and Step 4 texts.

    3. source for M15 General Principles for Model-Informed Drug Development v1

      Consultation closed (EU public consultation)

    4. source for M15 General Principles for Model-Informed Drug Development

      Consultation opened (EU public consultation)

    5. source for M15 General Principles for Model-Informed Drug Development

      Step 2 endorsed

      First published version.

    [...] agent-based models, disease progression models, and artificial intelligence/machine learning. M&S methods and approaches may be used alone or in combination.

    Source: ICH M15, © ICH.

    MHRA Inspectorate

    Use of AI for GXP inspection responses: setting standards without stifling innovation

    Published

    Blog post Not guidance

    Blog post (MHRA's current thinking)

    Key dates

    Posted

    MHRA Inspectorate blog post, posted on June 29, 2026, that sets out MHRA's current thinking on the use of AI in submissions to the MHRA Compliance Teams following GxP inspections. It is a blog post, not guidance, and it is not binding. It says all submissions and responses must be factually accurate and verifiable, technically reviewed by appropriately experienced people, signed off by someone with authority and accountability, supported by evidence for factual claims, and appropriate to the specific regulatory context.

    • Inspections

    Hristos's reading

    A GxP team that uses AI to draft a response to the MHRA Compliance Teams after an inspection can read this as the inspectorate's current thinking on accuracy, review, sign-off, evidence for factual claims, and appropriateness to the specific regulatory context. It is a blog post, not guidance, and it is not a binding rule.

    History, related documents and source excerpt

    What changed and when

    1. source for Use of AI for GXP inspection responses: setting standards without stifling innovation

      Posted

      First published version.

    All submissions/responses must be: • factually accurate and verifiable • technically reviewed by appropriately experienced people • signed off by someone with authority and accountability • supported by evidence for factual claims • appropriate to the specific regulatory context.

    Source: MHRA Inspectorate, ‘Use of AI for GXP inspection responses: setting standards without stifling innovation.’ Contains public sector information licensed under the Open Government Licence v3.0.

    How this list works

    Sources are the official issuer pages. Each entry is checked against its source and approved by Hristos before it appears.

    Once an entry is reviewed, a short quote from the source appears with a credit line, where the issuer's reuse terms allow it.

    English and official English versions only. Machine translation is used only for checking.

    Archive copies (Wayback Machine or archive.today) are made in a monthly batch, and until a copy exists the entry shows "Archive pending".

    Checked weekly for new items; every entry re-checked monthly.

    Spot an error or a missing source? Tell me and I'll fix it quickly.

    This page summarizes public documents from regulators and legislators about AI in pharmaceutical work. It is for information only and is not legal or regulatory advice. Summaries and Hristos's reading are the site owner's interpretation, not the issuer's. Status and dates can change after our last check, so always read the current version on the issuer's website before relying on it. Not affiliated with or endorsed by any regulator.