Regulatory Landscape
Guidelines, papers, and resources from EMA, FDA, AIFA, ISPOR, MHRA, NICE, WHO.
EMARegulatory guideline
ICH M15 Guideline on general principles for model informed drug developmentEMA · Regulatory guideline · AI · RCT
2026PDF ↓
EMARegulatory guideline
Guiding principles of good AI practice in drug developmentEMA / FDA · Regulatory guideline · AI · AI governance
2026PDF ↓
EMAWorkplan
NDSG workplan 2026-2028 - Data and AI in medicines regulationEMA · Workplan · Synthetic Data · AI/Data governance
2026PDF ↓
EMARegulatory guideline
Data Quality Framework for EU medicines regulation: application to Real-World DataEMA · Regulatory guideline · RWE, Data governance
2026PDF ↓
AIFARegulatory guideline
Guida AIFA alla presentazione della domanda di autorizzazione di Sperimentazioni Cliniche che prevedano sistemi di AI/MLAIFA · Regulatory guideline · AI · RCT
2026PDF ↓
WHORegulatory guideline
Artificial intelligence is reshaping health systems: state of readiness across the European UnionWHO · Regulatory guideline · Synthetic Data · AI/Data governance
2026PDF ↓
AIFADossier
INTELLIGENZA ARTIFICIALE E SALUTE: Come l’IA sta rivoluzionando la ricerca farmaceutica, la medicina di precisione e il futuro della salute globaleAIFA · Dossier · AI · RWE/RCT
2026PDF ↓
EMARegulatory guideline
Review of AI/ML applications in medicines lifecycle (2024)EMA · Regulatory guideline · AI · AI governance, RCT, RWE
2025PDF ↓
FDARegulatory guideline
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological ProductsFDA · Regulatory guideline · AI · AI governance, RCT, RWE
2025PDF ↓
ISPORScientific guideline
ISPOR commento to "Data Quality Framework for EU medicines regulation: application to Real-World Data"ISPOR · Scientific guideline · Synthetic Data · RWE, Data governance
2025PDF ↓
EMARegulatory guideline
Draft Concept Paper on the Development of a Reflection Paper on the Use of External Controls for Evidence Generation in Regulatory Decision-MakingEMA · Regulatory guideline · External control · RWE
2025PDF ↓
MHRARegulatory guideline
MHRA draft guideline on the use of external control arms based on real world data to support regulatory decisionsMHRA · Regulatory guideline · External control · RWE
2025PDF ↓
MHRARegulatory guideline
AI Airlock Sandbox Pilot Programme ReportMHRA · Regulatory guideline · Synthetic Data · AI governance
2025PDF ↓
ISPORScientific paper
ELEVATE-GenAI: Reporting Guidelines for the Use of Large Language Models in HEORISPOR · Scientific paper · AI · HTA
2025PDF ↓
ISPORScientific paper
Generative Artificial Intelligence for Health Technology Assessment: Opportunities, Challenges, and Policy ConsiderationsISPOR · Scientific paper · Synthetic Data · HTA
2025PDF ↓
ISPORScientific paper
A Taxonomy of Generative Artificial Intelligence in Health Economics and Outcomes Research: An ISPOR Working Group ReportISPOR · Scientific paper · Synthetic Data · HTA
2025PDF ↓
EMAQualification opinion
Qualification opinion for Artificial Intelligence-Based Measurement of Non-alcoholic Steatohepatitis Histology in Liver Biopsies to Determine Disease Activity in NASH/MASH Clinical TrialsEMA · Qualification opinion · AI · RCT
2025PDF ↓
EMARegulatory guideline
Reflection paper on use of real-world data in noninterventional studies to generate real-world evidence for regulatory purposesEMA · Regulatory guideline · RWE
2025PDF ↓
EMA
The European Medicines Agencies Network Data Strategy: Increasing the value of data for the benefit of public and animal healthEMA · Data governance
2025PDF ↓
EMARegulatory guideline
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycleEMA · Regulatory guideline · Synthetic Data · AI governance
2024PDF ↓
EMARegulatory guideline
Guiding principles on the use of large language models in regulatory science and for medicines regulatory activitiesEMA · Regulatory guideline · AI · AI governance
2024PDF ↓
NICERegulatory guideline
Use of AI in evidence generation: NICE position statementNICE · Regulatory guideline · AI · HTA, RWE, AI governance
2024PDF ↓
AIFARegulatory guideline
Linea Guida AIFA per la classificazione e conduzione degli studi osservazionali sui farmaciAIFA · Regulatory guideline · RWE
2024PDF ↓
EMAWorkplan
Multi-annual artificial intelligence workplan 2023-2028: HMA-EMA joint Big Data Steering GroupEMA · Workplan · AI · AI governance
2023PDF ↓
EMA
Data Quality Framework for EU medicines regulationEMA · Data governance
2023PDF ↓
EMARegulatory guideline
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in PharmacoepidemiologyEMA · Regulatory guideline · RWE, Data governance
2023PDF ↓
ISPORScientific paper
Machine Learning Methods in Health Economics and Outcomes Research - The PALISADE Checklist: A Good Practices Report of an ISPOR Task ForceISPOR · Scientific paper · AI · HTA
2022PDF ↓
EMAQualification opinion
Qualification opinion for Prognostic Covariate AdjustmentEMA · Qualification opinion · AI · RCT, RWE
2022PDF ↓
EMARegulatory guideline
Guideline on registry-based studiesEMA · Regulatory guideline · RWE
2021PDF ↓
EMA
European Medicines Regulatory Network Data: Standardisation StrategyEMA · Data governance
2021PDF ↓
EMARegulatory guideline
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trialsEMA · Regulatory guideline · RCT
2020PDF ↓