Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain
the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in
Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles
and JavaScript.
Cloud-based data systems in drug regulation: an industry perspective
Cloud-based systems for data submitted by sponsors to drug regulatory agencies have the potential to accelerate drug development, streamline regulatory review and enhance regulatory decision-making. Here, we provide a vision for integrating cloud-enabled practices in drug regulation globally.
The drug regulatory review process currently relies on transmission of discrete datasets, documentation and regulatory submissions from the sponsor company to designated regulatory authorities. Regulatory submissions primarily consist of hyperlinked documents and electronic submissions that highlight relevant company-generated data and analysis, and are created through a specific process — data are collated, interpreted and presented in a ‘closed’ standard template. Regulatory authorities often partition submissions across disparate platforms by company and/or product. This approach is resource intensive, and limits information exchange between, and within, companies and regulators.
Prices may be subject to local taxes which are calculated during checkout
Nature Reviews Drug Discovery19, 365-366 (2020)
doi: https://doi.org/10.1038/d41573-019-00193-7
Acknowledgements
The authors are members of the Charles Forum, founded in 2018 by request of the Hever Group of Pharmaceutical R&D heads to advance the identification, prioritization, and pursuit of progressive and global issues affecting biopharmaceutical industry regulation. Current Charles Forum members include regulatory heads and regulatory policy leads from 12 multinational biopharmaceutical companies. The authors acknowledge the many industry consortia working in partnership with the FDA to advance information exchange through cloud technologies.
