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However, the patent term on the main compound has been extended by over five years as a result of a Patent Term Adjustment (PTA) and a Patent Term Extension (PTE)

Cross-agency trends: AI, harmonization, and real-time oversight In January 2026, the FDA and EMA jointly published ten guiding principles for good AI practice in drug development, covering AI use across the full medicines lifecycle from nonclinical and clinical development through manufacturing and post-market safety surveillance. Other regulators, including Chinas NMPA and Indias CDSCO, alongside the MHRA, are separately moving toward adaptive pathways and rolling review models

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Cellular energy and metabolic signalling models