AI regulation news for pharmaceutical and life sciences https://javai.ch/pharma/ 360 Mon, 23 Mar 2026 00:00:00 GMT https://artificialintelligenceact.eu/ai-act-explorer/ https://artificialintelligenceact.eu/ai-act-explorer/ Mon, 23 Mar 2026 00:00:00 GMT Implementation Documents Browse the AI Act online using our AI Act Explorer This page lists all documents associated with the implementation of the AI Act. It will be updated as new documents are published. artificialintelligenceact.eu global eu ai-act tracker implementation https://www.edps.europa.eu/system/files/2025-11/2025-11-11_ai_risks_management_guidance_en.pdf https://www.edps.europa.eu/system/files/2025-11/2025-11-11_ai_risks_management_guidance_en.pdf Tue, 11 Nov 2025 00:00:00 GMT Structured AI risk management guidance covering accountability, procurement, deployment, and risk controls. One of the best official European documents on AI risk management. EDPS global eu data-protection risk-management ai-governance https://www.edps.europa.eu/system/files/2025-09/25-09-15_techdispatch-human-oversight_en.pdf https://www.edps.europa.eu/system/files/2025-09/25-09-15_techdispatch-human-oversight_en.pdf Mon, 15 Sep 2025 00:00:00 GMT Highlights the need for standardised frameworks and metrics to assess whether human oversight of automated systems is actually effective. EDPS global eu human-oversight automated-decision-making metrics https://digital-strategy.ec.europa.eu/en/library/guidelines-scope-obligations-providers-general-purpose-ai-models-under-ai-act https://digital-strategy.ec.europa.eu/en/library/guidelines-scope-obligations-providers-general-purpose-ai-models-under-ai-act Fri, 18 Jul 2025 00:00:00 GMT Commission guidelines on GPAI provider obligations: technical documentation, copyright compliance, training data summaries. For systemic risk models: risk assessment, incident reporting, cybersecurity. European Commission global eu ai-act gpai provider-obligations https://www.edpb.europa.eu/system/files/2025-04/ai-privacy-risks-and-mitigations-in-llms.pdf https://www.edpb.europa.eu/system/files/2025-04/ai-privacy-risks-and-mitigations-in-llms.pdf Tue, 1 Apr 2025 00:00:00 GMT Practical risk treatment for LLM deployments. Discusses deployer responsibilities in relation to provider risk treatment, fine-tuning, and retraining. EDPB global eu data-protection privacy llm risk-management https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers https://digital-strategy.ec.europa.eu/en/faqs/ai-literacy-questions-answers Sun, 2 Feb 2025 00:00:00 GMT Article 4 requires providers and deployers to ensure sufficient AI literacy of staff dealing with AI systems. Already in force since February 2025, with enforcement from August 2026. European Commission global eu ai-act literacy article-4 https://www.edpb.europa.eu/system/files/2024-12/edpb_opinion_202428_ai-models_en.pdf https://www.edpb.europa.eu/system/files/2024-12/edpb_opinion_202428_ai-models_en.pdf Tue, 17 Dec 2024 00:00:00 GMT Addresses when AI models may be considered anonymous, whether legitimate interests can support model training, and consequences of unlawful personal data processing in model development. EDPB global eu data-protection privacy gdpr ai-models https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689 Thu, 1 Aug 2024 00:00:00 GMT The EU AI Act entered into force, establishing the world's first comprehensive legal framework for AI. Sets risk-based obligations for providers and deployers including conformity assessment, risk management, documentation, logging, human oversight, and declared accuracy metrics. European Commission global eu ai-act legislation https://www.edpb.europa.eu/system/files/2024-05/edpb_20240523_report_chatgpt_taskforce_en.pdf https://www.edpb.europa.eu/system/files/2024-05/edpb_20240523_report_chatgpt_taskforce_en.pdf Thu, 23 May 2024 00:00:00 GMT Shows how EU data protection authorities think operationally about generative AI services. Covers governance, transparency, lawful basis, accuracy, and safeguards for LLM deployments. EDPB global eu data-protection gdpr chatgpt generative-ai https://www.iso.org/standard/81230.html https://www.iso.org/standard/81230.html Mon, 18 Dec 2023 00:00:00 GMT International standard for AI management systems covering risk management, documentation, and continuous improvement for organisations developing or using AI systems. ISO global standard iso-42001 ai-management-system certification https://doi.org/10.6028/NIST.AI.100-1 https://doi.org/10.6028/NIST.AI.100-1 Thu, 26 Jan 2023 00:00:00 GMT Framework for managing AI risks emphasising Govern, Map, Measure, and Manage functions. Unusually strong on measurement and ongoing risk monitoring, including thresholding, validation, and drift detection. NIST global standard risk-management us monitoring measurement https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/artificiel-intelligence.html https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/artificiel-intelligence.html Mon, 1 Jan 2024 00:00:00 GMT The key Swissmedic page on AI in the medicinal-product context — development, manufacture, and regulatory process. Swissmedic swiss pharma biotech medicine swissmedic ai-governance https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf Mon, 1 Jul 2024 00:00:00 GMT Central EU guidance for pharma teams using AI in R&D, clinical development, manufacturing, pharmacovigilance, or regulatory submissions. EMA eu pharma biotech medicine ema ai-governance