The use of Artificial Intelligence technologies across medicines lifecycle has significantly increased in recent years and holds great promise as a tool to accelerate the path from innovation to safe and efficacious medicines.
In this context, the European Medicine Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly identified to inform, enhance, and promote the use of Artificial Intelligence for generating evidence across all phases of the medicine product lifecycle:
- 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
- Clear, essential information
They identify areas where the international regulators, international standards organisations, and other collaborative bodies could work to advance good practice in medicine development and harness the potential of Artificial Intelligence technologies, while ensuring patient and animal safety and regulatory compliance. The principles emphasise the importance of using an ethical, human-centric and risk-based approach to the development and use of Artificial Intelligence technologies, ensuring adherence to recognised standards, a well-defined context of use, planned monitoring, periodic re-evaluation and transparency for the intended audience.
Over time, these principles will be supplemented by additional EU guidance taking into account the applicable legal requirements and relevant new EU legislation in the area of medicines.
To learn more about this topic, please consult the EMA website at the following link: EMA and FDA set common principles for AI in medicine development | European Medicines Agency (EMA)