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# FDA, EMA Drug Development AI Principles
- URL: https://www.fdaweb.com/fda-ema-drug-development-ai-principles/
- Published: 2026-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:30:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160486

Following several months of collaboration, FDA and the European Medicines Agency have published a document outlining 10 guiding principles for good artificial intelligence (AI) practice in drug development. An FDA [statement](https://content.govdelivery.com/accounts/USFDA/bulletins/4042e31?ref=fdaweb.com) says the “integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving healthcare…. These 10 guiding principles lay the foundation for developing good practice that addresses the unique nature of these technologies and identifies areas for potential collaboration by international regulators, international standards organizations, and other collaborative bodies.”

The 10 [principles](https://www.fda.gov/about-fda/artificial-intelligence-drug-development/guiding-principles-good-ai-practice-drug-development?utm%5Fmedium=email&utm%5Fsource=govdelivery) are:

- human-centric by design;
- risk-based approach;
- adherence to standards;
- clear context of use;
- multidisciplinary expertise;
- data governance and documentation;
- model design and development practices;
- risk-based performance assessment;
- life-cycle management; and
- clear, essential information.