The future of regulatory filings: digitalization

Abstract The biopharmaceutical industry, while advancing rapidly in drug development, has lagged in the digitalization of regulatory submissions, leading to inefficiencies, delays, and increased administrative burdens. Current processes rely heavily on manual input, increasing labor burdens and the risk of errors, which in turn prolongs the preparation and submission of regulatory documents and delays global market access for patients. This review explores the transformative potential of emerging digital solutions such as Structured Content and Data Management (SCDM), Artificial Intelligence (AI), and cloud-based platforms. These technologies offer significant advantages, including automation of document preparation, real-time data integration, and enhanced collaboration between sponsors and global health authorities. Additionally, efforts to standardize data formats, such as PQ/CMC, ISO IDMP, and HL7 FHIR, are foundational to creating a harmonized framework for seamless information exchange. By integrating these tools and adopting standardized practices, the industry can reduce errors, improve compliance, and accelerate timelines for global regulatory approvals. Ultimately, this digital transformation can deliver more efficient pathways to market, increasing manufacturing capacity while reducing medicinal waste and ensuring faster patient access to new therapies. Implementation of digitalization practices will position the biopharmaceutical industry at the forefront of innovation in a rapidly evolving regulatory environment. Graphical Abstract