OPTIMISING GLOBAL ECTD SUBMISSIONS: HARMONISATION CHALLENGES AND SOLUTIONS

Abstract

This research examines how to optimise both global eCTD submissions while identifying discrepancies and noting the lack of harmonisation between regulatory agencies in various countries. Through case study reviews and analysis of industry reports and secondary data, the research outlines barriers to creating, submitting, and marketing eCTDs, such as varying validation criteria, scalability, and human error. However, solutions are highlighted, such as automation and standardized processes, to help overcome these barriers. Ultimately, the research concludes a case for why pharmaceutical companies should be collaborating with regulatory agencies to eliminate barriers to global eCTDs and submission, and the time it takes to approve and remain compliant. Finally, recommendations for future solutions for optimisations are suggested.