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PDA Task Force Releases Post-Approval Changes Workplan

by Walter Morris, PDA | Oct 03, 2016

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.