Abstract
The COVID-19 crisis has demonstrated that the global regulatory framework for managing post- approval changes (PACs) is not capable of handling a pandemic. Emergency procedures have been implemented across the globe to avoid drug shortages. By working drastically differently together, the unimaginable happened: in less than a year, a vaccine was developed, approved, produced and provided to people. In light of these actions, there exists a unique opportunity to retire the old system for managing PACs and replace it with a new agile and patient-centric approach built on lessons learned from the global pandemic response. This new approach must be science- and risk-based, rendering it capable of not only managing the response to a future pandemic but also facilitating the implementation of new knowledge in close to real-time. Major steps will then be able to be taken to secure the supply chain, incentivise continual improvement and innovation and ultimately avoid drug shortages. These solutions must reflect the following: that diseases and science are global in nature, that more harmonisation in how collectively work is done while taking strength in unique competencies and experience is strived for, and that a national sovereignty of decision-making is acknowledged. Industry and regulators need to develop a common language and understanding of regulatory reliance and regulatory flexibility and use that to make work products transparent to those in the field. This opportunity cannot be missed: industry and regulators cannot fail those depending on the supply of drug products or vaccines wherever they may live. This article describes both a vision and a practical approach to reduce drug shortages worldwide.
DOI
https://doi.org/10.21427/5ka9-a139
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.
Recommended Citation
Vinther, Anders
(2024)
"Lessons Learned from COVID-19 is an Opportunity to Reduce Drug Shortages - Vision and Practical Solutions,"
Journal of Applied Pharmaceutical Regulatory Science:
Vol. 1:
Iss.
1, Article 6.
doi:https://doi.org/10.21427/5ka9-a139
Available at:
https://arrow.tudublin.ie/japrs/vol1/iss1/6
