Abstract
The complex global problem of managing post-approval changes (PACs) and its significant constraint on manufacturers’ agility to continuously improve and address supply chain challenges has been known for over two decades. Attempts to solve the problem so far have not been successful, partly because this has been treated as a complicated and not a complex problem.
Data from over 145,000 PACs across 156 countries reveals the severity of the issue; a global PAC rarely receives unanimous global approval within the World Health Organization (WHO)-recommended review timeline of six months. This leads to a significant time lag between the acquisition of new knowledge about products and their manufacturing processes, and the implementation of such new knowledge into daily operations, making timely continual improvement near impossible. Addressing this challenge requires a holistic approach that can alleviate the complex problem at a different level of thinking than the one that created it. This article explores how systems thinking can alleviate this complex problem and revolutionize the Global PAC Management System.
DOI
https://doi.org/10.21427/32my-0762
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.
Recommended Citation
Ramnarine, Emma and Vinther, Anders
(2024)
"Applying Systems Thinking to Navigate the Global Regulatory Complexity Problem for Post-Approval Changes,"
Journal of Applied Pharmaceutical Regulatory Science:
Vol. 1:
Iss.
1, Article 7.
doi:https://doi.org/10.21427/32my-0762
Available at:
https://arrow.tudublin.ie/japrs/vol1/iss1/7
