PDA’s Post Approval Change Innovation
for Access to Medicines (PAC iAMsm)
Task Force of volunteer industry experts
has issued a call to action, inviting the broader pharmaceutical
industry and regulatory community to
join with them in tackling this “wicked problem."
Current disharmonized national and
regional post-approval change (PAC)
regulations require companies to submit
filings with agencies worldwide in order
to gain permission to make most changes
to manufacturing systems, analytical
methods, and processes. In many cases,
the PAC process takes several years, and
manufacturers must produce multiple
batches of the same product while they
await approval for a change in one region/
country, which has already been
approved in others.
PDA’s task force has the following objectives:
- Bring awareness to current challenges
and enable stronger collaboration
amongst opinion leaders and
key stakeholders (within industry,
regulatory agencies, and other relevant
stakeholder forums)
- 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
Product Quality Systems (PQS)
The task force will produce several position
papers for the PDA Journal of
Pharmaceutical Science and Technology
over the coming months. The group will
also be conducting an industry survey to
gather information to support a future
PDA technical report and examples of
global PAC protocols on the topic.