Global Regulatory Intelligence: Leveraging Data for Faster ECTD Approvals

Abstract

The present research investigates the utilisation of global regulatory intelligence to improve the review and approval process of electronic Common Technical Document (eCTD) submissions. With the integration of AI, automated systems, and real-time data monitoring, pharmaceutical organisations can improve the regulatory submission process, ensuring fewer submission errors occur and submission and review times shorten.  Through a series of case studies showcased by utilising Astra-Zeneca and GSK, substantial improvements to approval processes were demonstrated.  In the face of significant advances in regulatory intelligence and eCTD submissions, specific limitations such as the ability to accommodate changes in global regulations and regional complexity. Future research will look to standardise submission globally, while also seeking industry leaders who may develop cost-free AI options to improve regulatory compliance and operational efficiencies.