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Post-Approval Change Management Protocol (PACMP)
Post-Approval Change Management Protocol (PACMP)
A regulatory tool that provides predictability and transparency in terms of requirements and studies needed to implement a change as the approved protocol (that describes the CMC change an MAH intends to implement during the commercial phase of a product lifecycle, how the change would be prepared and verified, including assessment of the impact of the proposed change, and the suggested reporting category in line with regional regulations and guidance) provides an agreement between the MAH and the regulatory authority.