Pharma & Healthcare
Key Resources
Swiss Governance
- Swissmedic: AI in medicinal product development The key Swissmedic page on AI in the medicinal-product context.
- FDPIC: Current data protection legislation is directly applicable to AI Critical for any Swiss pharma use of AI involving patient, trial, or employee data.
- Federal Council: AI regulation — ratification of Council of Europe Convention Key policy announcement on Swiss AI regulation, including sector-specific regulation for healthcare.
- Federal Council: Switzerland signs Council of Europe Convention on AI Follow-on announcement confirming formal signature in March 2025.
- Swissmedic: Horizon Scanning Focus areas include AI, digitalisation, and new therapeutic procedures.
- Swissmedic 4.0: Digital initiative concludes Context on Swissmedic's internal build-up of competence in digitalisation, AI, and data science.
EU/UK and International Governance
- EMA: Reflection paper on AI in the medicinal product lifecycle (PDF) Central EU guidance for pharma teams using AI across the product lifecycle.
- EMA: Artificial intelligence in medicines regulation EMA overview page for AI work in medicines regulation.
- European Commission: Artificial intelligence in healthcare EU policy and regulatory landscape for AI in healthcare, including AI Act implications.
- EU AI Act — Regulation (EU) 2024/1689 Primary legal text. Relevant whenever AI systems or processes touch the EU market.
- EMA: Medical devices overview Important where pharma overlaps with AI-enabled software, diagnostics, or combination products.
- FDA: Artificial intelligence and medical products FDA gateway to AI-related material on drugs and medical devices.
- UK AI Airlock: regulatory sandbox for AI as a medical device UK sandbox programme exploring how AI as a medical device (AIaMD) should be regulated.
- HRA: AI and the Health Research Authority UK health research authority perspective on AI governance and oversight.
Strategic announcements
- EMA and FDA set common principles for AI in medicine development Signals transatlantic regulatory convergence around AI in medicine development.
- EMA/HMA: Leveraging the power of data for public and animal health Strategic direction for data and AI in the European medicines regulatory network.
- EMA/HMA Network Data Steering Group Workplan 2026–2028 (PDF) How AI and data regulation in medicines will evolve over the next several years.
New to RSS? It delivers updates directly to your reader — no social media, no algorithms. Learn how to get started
Loading feed…