The use of AI technologies across the medicines lifecycle has increased significantly in recent years. As emphasised in the European Commission’s Biotech Act proposal, AI holds great promise as a tool to accelerate the path from innovation to safe and effective medicines. The new pharmaceutical legislation accommodates the broader use of AI in the lifecycle of medicines in regulatory decision-making, and creates additional possibilities for testing innovative AI driven methods for medicines in a controlled environment.

To realise these benefits, AI needs to be expertly managed, including the mitigation of risks. As AI continues to evolve, a principles-based approach will help regulators, pharmaceutical companies and medicines developers harness the potential of these technologies while ensuring patient and animal safety and regulatory compliance. Over time, these principles will be supplemented by additional EU guidance taking into account the applicable legal requirements and…