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Scottish Medicines Consortium · UK · 3 Nov 2026 · Guidance

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

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The Scottish Medicines Consortium has published a position statement providing guidance for pharmaceutical companies on using artificial intelligence in submissions to SMC. The statement sets out principles for transparency, human oversight, scientific rigour, data governance, and relevance to NHS Scotland, and provides practical guidance on disclosing AI use in submissions. SMC supports responsible AI use that adds value while maintaining existing methodological standards and requirements.

Dates and deadlines
Regulatory deadline
3 Nov 2026
From Scottish Medicines Consortium

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.

Excerpt from the official page. The original is authoritative.