رئيس هيئة الغذاء والدواء: الذكاء الاصطناعي والمحاكاة الحاسوبية يفتحان آفاقًا لتسريع تطوير الأدوية، خصوصًا للأمراض النادرةSFDA CEO: AI and computer simulation open new horizons for speeding drug development, especially for rare diseases

The CEO of the Saudi Food and Drug Authority (SFDA), Dr Hisham S. Aljadhey, said artificial intelligence and computer simulation offer promising opportunities to accelerate drug development and improve the efficiency of clinical studies. He said this can help provide reliable scientific evidence to support regulatory decisions and make it easier for patients to reach safe and effective treatments, especially for rare diseases. He spoke during the annual summit of the International Coalition of Medicines Regulatory Authorities (ICMRA) in Seoul, hosted by South Korea's Ministry of Food and Drug Safety.

His presentation was titled "In Silico Clinical Trials: From Simulation to Regulatory Evidence," in a session on global trends and practical strategies for using AI in medicines regulation. He said the technologies can speed clinical studies, strengthen the scientific evidence behind regulatory decisions and reduce burdens on patients, while maintaining quality, safety and efficacy requirements. For rare diseases, traditional trials face challenges because patient numbers are limited and recruitment is difficult. He said computer simulation can complement and improve the design of traditional studies and, in appropriate cases, replace some of their parts.

He said the authority is preparing a supportive regulatory environment through the NADR pathway for rare-disease drugs, general considerations for using AI in clinical development, and the SFDA AI Lab (SAIL) to help test and evaluate applications in regulatory science. He stressed that benefit depends on the reliability of the resulting evidence and whether it is valid to support regulatory decisions, which requires data quality, model validation, transparency, human oversight and stronger international cooperation.

The session also covered experiences from other regulators, with representatives from the US FDA, the European Medicines Agency, the UK MHRA, Spain's AEMPS and Brazil's Anvisa. SFDA describes itself as the first regulatory authority from the Middle East and North Africa to gain full membership in the coalition. The news is about a regulatory direction and a summit presentation, not approval of a new medicine or a finished product.