In April this year, the UK Medicines and Healthcare products Regulatory Agency (Mhra) published a paper exploring the influence of artificial intelligence (AI) on the regulation of medical products. The paper, entitled “Impact of AI on the Regulation of Medical Products”, is structured in three parts, each of which reflects one of the different roles that the agency can take on in the context of AI.

AI Product Regulator

Currently, these devices are regulated under the Medical Devices Regulations 2002, which covers the entire product life cycle, from pre-market clinical trials to post-market surveillance. With the evolution of AI,the Mhra intends to update the regulations to guarantee a regulation capable of balancing the needs in terms of safety and effectiveness and risk management without stifling innovation. The agency has published several guidelines for AI device manufacturers and expects additional documents by 2025.

Public service organisation

In this role, the MHRA is leveraging artificial intelligence to improve the efficiency of its regulatory processes. In particular, it wants to use advanced technologies such as supervised machine learning to optimize the initial evaluation of authorization applications for new medicines, in order to significantly reduce the time needed to approve products while maintaining safety requirements and effectiveness.

This innovation allows human reviewers to focus on critical activities that require advanced skills, such as innovation enablement (the set of strategies implemented to facilitate and promote the development and implementation of new technologies in the healthcare sector) and engagement of patients. Furthermore, the English Agency is developinga comprehensive data strategy, which includes the adoption of large language models (LLM) and generative AIto support various business functions, from c >communication to customer service, up to post-market surveillance.

For the complete article, visit the Making Pharma Industry website. Click here.