Regulatory Approval and Challenges in the Digital Era

Abstract

In the pharmaceutical industry, the regulatory landscape has evolved significantly, influenced by historical tragedies and pivotal figures such as regulatory strong holds. The introduction of regulations like the 1962 drug amendments in the United States revolutionized drug regulation, emphasizing safety and efficacy standards. The adoption of the common technical document (CTD) format and its electronic counterpart, the eCTD, has streamlined regulatory submissions globally. However, the digital era presents new challenges and opportunities, including the integration of digital tools like big data analytics and artificial intelligence (AI) into drug development and regulatory processes. Despite the potential benefits, challenges such as data protection, compliance, and regulatory adaptation to emerging technologies remain. The future of regulatory affairs lies in harnessing digital innovations while ensuring the integrity and credibility of the approval process, requiring collaboration between stakeholders and adaptation to evolving technologies.