Comment from The Arab Expert's Office at the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances (AUPAM)

Summary: The Arab Expert's Office at the Arab Union of Pharmaceutical Manufacturers (AUPAM) supports the draft guidance on New Approach Methodologies (NAMs) in drug development, praising its structural framework and scientific grounding. They propose twelve specific technical revisions to improve clarity on validation standards, data integrity, AI/ML integration, and global reliance pathways to ensure the guidance is internationally interoperable and practical for manufacturers.