Comment from Digital CMC CERSI, led from CMAC, University of Strathclyde, UK

Dear Sir/Madam The Centre of Excellence for Regulation Science and Innovation (CERSI) for the Digital Transformation of Medicines Development and Manufacturing is grateful for the opportunity to provide feedback on the referenced draft guidance. This UK based CERSI is a newly established centre (February 2025) focused on the digital transformation of Chemistry, Manufacture and Controls (CMC) procedures. It is led by the University of Strathclyde, with funding from the UK Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with Innovate UK, the Office for Life Sciences and the Medical Research Council (MRC). Please note that these comments are the view of this Digital CMC CERSI and its members, and not that of the MHRA. The founding partners of the centre include CMAC (an advanced medicines manufacturing research centre at the University of Strathclyde), De Montfort University, the Cambridge Crystallographic Data Centre (CCDC), global pharmaceutical companies including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline and Pfizer, as well as Siemens, a leading digital technology company. Thank you for considering our input. We look forward to the development of clear guidance regarding the use of artificial intelligence in supporting regulatory decisions. Best wishes Prof Daniel Markl Head of Digital CMC CERSI Technology and Innovation Centre 99 George Street Glasgow G1 1RD