Vinther, Anders
Ramnarine, Emma
Gastineau, Thierry
O’Brien, Laura
Brehm, Oliver
Fryrear, David
Article History
Received: 19 June 2023
Accepted: 8 January 2024
First Online: 18 February 2024
Declarations
:
: The authors declare no competing interests. The CQOs represent global innovator pharma companies. This article presents their view on the problem of global regulatory complexity for managing PACs, it’s impact on continual improvement, and the risk to drug product supply as well as approaches that can help alleviate the problem.
: Senior Quality leaders (Chief Quality Officers and Heads of Quality) from the 25 largest global pharmaceutical companies are speaking with “One-Voice-Of-Quality” for Post-Approval Changes (1VQ for PAC Initiative) to advocate for an effective management of specific PACs that currently are handled as a prior-approval change in some countries, but where a standard science and risk-based approach concludes that these should be downgraded to a notification or handled only in the PQS.