Barriers to innovation during lifecycle management of a product are multiple. They notably include the complexity of the current post-approval
change (PAC) regulatory environment. Recognizing the need for action, several international organizations are currently working
toward the global convergence of regulatory requirements for PACs.
In 2014, ICH began its work on ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The
main objective of ICH Q12 is to facilitate predictable and efficient PAC management in order to support innovation and ensure reliable
product supply. PDA launched its Manufacturing Science and Operations Program (MSOP) in 2014 and offered a Manufacturing Science
workshop addressing the barriers for implementation of PACs the following year.
Shortly before the workshop, a team of highly motivated PDA volunteers gathered to form a task force and set out to develop a new
PDA technical report that would supplement ICH Q12 by offering specific solutions to facilitate innovation and industry collaboration.
The task force later expanded its portfolio of planned activities to include other documents covering related topics and tools. New team
members joined. And after a face-to-face meeting in January 2016, the task force decided to continue the journey under a new name and
program: “Post-Approval Changes: Innovation for Access to MedicinesSM,” or PAC iAM.
The PAC iAM program has the following objectives:
- Bring awareness to current challenges and enable stronger collaboration
among opinion leaders and key stakeholders
- Foster a science- and risk-based approach to PAC management
and regulatory decision-making for global product quality, safety,
and efficacy assessments
- Encourage international convergence/standardization in PAC
management in a manner that can foster and enable mutual reliance
between regulatory authorities
- Manage PACs through the use of an effective Pharmaceutical
Quality System (PQS)
Last year turned out to be a very busy year for the PAC iAM team. First, the team raised awareness of the issue in a call to action, inviting the broader pharmaceutical industry and regulatory community to join efforts in tackling the “wicked problem”
of drug shortages (see “Drug Shortage is a “Wicked Problem’” by Anders Vinther).
Members of the task force also authored a series of Points to Consider (PtC) papers on technical product lifecycle management for
publication in the PDA Journal of Pharmaceutical Science and Technology. The first PtC paper, entitled “Communication and Knowledge
Exchange between Marketing Authorization Holders and Health Authorities,” was published in January. The second PtC paper, entitled
“Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes,” published in February, elaborates on the role of
the pharmaceutical quality system (PQS) in supporting effective change management. The paper describes how opportunities outlined
in ICH Q10: Pharmaceutical Quality System can be used to manage product and process changes within the PQS to reduce regulatory
reporting requirements. A third PtC paper covering Quality Risk Management
and knowledge management for PACs is currently in development.
In the fall of 2016, members of the task force formed a team to work on a PAC technical report that focuses on the practical aspects of
PAC management using science- and risk-based approaches and illustrates how an effective PQS can support change management. It will
be based on best practices across the industry. The technical report team intends to publish examples of Post-Approval Change Management
Protocols (PACMPs) that can be used for various manufacturing changes involving a range of product types.
Finally, in December 2016, PDA launched a survey on PACs to collect data on what resources companies expend handling PACs in the
current regulatory environment.
In light of all these activities that began in 2016, what is planned for 2017? Apart from the wealth of ongoing activities outlined above,
PDA intends to offer a PAC workshop immediately following the 2017 PDA/FDA Joint Regulatory Conference in September.
PAC iAM has taken us on an exciting journey so far that will surely continue. To learn more about the PDA PAC iAM program, please
visit our website.