Position Statement on the Use of Artificial Intelligence (AI) in Medicines Submissions

The Scottish Medicines Consortium (SMC) is pleased to announce that it has published a new position statement, providing guidance for pharmaceutical companies on the use of artificial intelligence (AI) in submissions to SMC.

The SMC position statement recognises the increasing use of AI in medicines development and HTA submissions and sets out key guiding principles to support its responsible and transparent use.

It outlines SMC's expectations regarding transparency and disclosure, human oversight, scientific rigour and validation, data governance, and the relevance of AI-supported evidence to NHS Scotland. It also provides practical guidance to help companies disclose how AI has been used in preparing their submissions.

SMC supports the responsible use of AI where it adds value, while ensuring that existing methodological standards and requirements for medicines submissions continue to be met.

The position statement is available in the Making a submission section of our website, here.