PACMP
Post-Approval Change Management Protocol
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A PACMP is a regulatory tool in which a marketing authorization holder describes a specific future change, the tests and studies that will be performed to assess it, acceptance criteria, and the reporting category — and gets that plan reviewed and agreed by the authority in advance. When the change is later made and the pre-agreed criteria are met, it can be implemented and reported under a reduced/agreed category rather than a full prior-approval submission. It gives predictability and a lighter downstream reporting burden to well-characterized changes.
A PACMP is essentially a pre-negotiated change: the risk conversation happens once, up front, and the eventual implementation is a data-driven confirmation against the agreed protocol. It suits changes a firm can foresee (for example, adding a manufacturing site or scaling up).
PACMPs are a headline tool of ICH Q12 and also exist within regional variation frameworks; the reporting relief available depends on the region's change-management legislation.
- —Regulator pre-agrees the plan, tests, and acceptance criteria for a future change
- —On meeting criteria, the change reports under a reduced/agreed category
- —Best suited to foreseeable, well-characterized changes
- —A core ICH Q12 tool; interacts with regional variation rules
ICH Q12 post-approval change management protocol provisions; EU variations framework comparability protocol (Regulation (EC) No 1234/2008).
Frequently asked questions
What does PACMP stand for?
PACMP stands for Post-Approval Change Management Protocol.
What is PACMP?
A PACMP is a regulatory tool in which a marketing authorization holder describes a specific future change, the tests and studies that will be performed to assess it, acceptance criteria, and the reporting category — and gets that plan reviewed and agreed by the authority in advance. When the change is later made and the pre-agreed criteria are met, it can be implemented and reported under a reduced/agreed category rather than a full prior-approval submission. It gives predictability and a lighter downstream reporting burden to well-characterized changes.
Which regulations cover PACMP?
ICH Q12 post-approval change management protocol provisions; EU variations framework comparability protocol (Regulation (EC) No 1234/2008).