The event focused on the impact of the EU AI Act on the life cycle of medicinal products in Europe and EMA’s position in this regard, emphasising the importance of AI in drug discovery and non-clinical development.
Discussions highlighted the importance of compliance with regulatory requirements throughout the drug life cycle.
Various stages of the drug life cycle were explored, including pre-clinical and clinical stages, commercialisation, and post-marketing activities.
Key Takeaways
- Early stages of drug development (drug discovery, non-clinical development) likely to fall under scientific research exemption → no impact in this case
- Where scientific research exemption does not apply, often low impact
- AI applications that meet the definition of a medical device under MDR/IVDR are high risk
- Compliance with AI Act must be proven to notified body
- Post-market surveillance and reporting system required
- Risk management
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