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Volume 29, Issue 9
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
The Parenteral Drug Association (PDA) has announced its Post Approval Changes: Innovation for Availability of Medicines (PAC iAM) Program, a call to action to reform the processes for postapproval changes (PACs) by promoting awareness of PAC challenges, applying science- and risk-based approaches to change management, and help streamline PAC processes. PDA hopes the program will help reduce the timeline for implementation of global PACs from years to months, which the association believes will promote innovation and enable an uninterrupted supply chain.
PACs may result from a response to regulatory requirements, a company’s desire to improve manufacturing and/or analytical processes, risk management, or advances in innovation. Global regulations imposed on product-related PACs can impact the supply of effective drugs as varied global regulatory processes can make implementation of PACs complex and difficult. PDA is hoping their program can help streamline the complex global PAC environment and address some of the challenges manufacturers face.
The PAC iAM Program will identify, assess, and address current barriers to implementation of PACs. PDA is planning on publishing science- and risk-based approaches to lifecycle management. The association will also create templates for standardized global postapproval change management protocols (PACMPs) for specific changes to manufacturing processes and analytical technologies and establish a library of real-world examples of best practices for PACs using a science- and risk-based approach. Forums to encourage collaboration and open dialog between stakeholders in healthcare are planned.
PDA is looking for volunteers with experience in postapproval changes to help with the development of a technical report. Those wishing to participate can contact PDA’s Science and Regulatory Affairs at firstname.lastname@example.org. The call to action document can be viewed on PDA's website.