New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19
Tóm tắt
The urgency and impact of the ongoing COVID-19 pandemic are changing global drug development and regulatory processes. The need for speed to understand the virus and develop new vaccines, medicines, and therapies for patients has provided unprecedented learning opportunities and revealed how the pharmaceutical industry can improve upon traditional processes. To stay competitive while remaining compliant with agency regulations and guidance, companies need to implement new process/tools that allow for more flexible work models, consider expanding the use of decentralized/hybrid trials, and capitalize on the use of real-world evidence (RWE) and cloud-based data systems. In addition, regulatory agencies should retain the agility exhibited during current reviews of potential new therapies, applying this momentum to other areas of unmet medical need. Further, agencies should consider a globally acceptable application platform. This article, by the Pharmaceuticals’ Head of Regulatory Affairs at Bayer AG, examines how impacts of the COVID-19 crisis will continue beyond the pandemic period to the benefit of patients, drug developers, regulators, clinicians, and caregivers.
Tài liệu tham khảo
European pharmaceutical industry response to COVID-19. Efpia.eu. https://www.efpia.eu/covid-19/member-updates/. July 2020. Accessed July 17, 2020.
Useem J. When Working From Home Doesn’t Work. The Atlantic. November 2017. https://www.theatlantic.com/magazine/archive/2017/11/when-working-from-home-doesnt-work/540660/. Accessed July 17, 2020.
Meakin L. Working From Home Means Working Longer Hours for Many. Bloomberg. March 2020. https://www.bloomberg.com/news/articles/2020-03-23/working-from-home-means-working-longer-hours-for-many-chart. Accessed July 17, 2020.
FDA. Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic. www.fda.gov. June 2020. https://www.fda.gov/news-events/fda-voices/fda-maintains-pace-meeting-its-goals-applications-medical-products-during-pandemic. Accessed July 17, 2020.
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and Answers. www.fda.gov. May 2020. https://www.fda.gov/media/138358/download. Accessed July 17, 2020.
Coronavirus (COVID-19) Update: Daily Roundup July 14, 2020. www.fda.gov. July 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-14-2020. Accessed July 17, 2020.
COVID-19: Important updates from Health Authorities and countries worldwide. www.parexel.com. July 2020. https://regulatory-access.parexel.com/covid-19/covid-19-health-authority-updates. Accessed July 17, 2020.
Rome B, Avorn J. Drug evaluation during the Covid-19 pandemic. N Engl J Med. 2020;382(24):2282–4. https://doi.org/10.1056/nejmp2009457.
Pitts P. Regulatory centaurs. Nat Biotechnol. 2020;38(7):788–9. https://doi.org/10.1038/s41587-020-0589-x.
Ledford H, Van Noorden R. High-profile coronavirus retractions raise concerns about data oversight. Nature. 2020;582(7811):160–160. https://doi.org/10.1038/d41586-020-01695-w.
Robertson A, Malone H, Bisordi F, et al. Cloud-based data systems in drug regulation: an industry perspective. Nat Rev Drug Discov. 2019;19(6):365–6. https://doi.org/10.1038/d41573-019-00193-7.