PACMP: post-approval change management protocol
A post-approval change management protocol (PACMP) pre-agrees the data for a future CMC change so the change can later be filed in a lower category.
In the EU a PACMP is agreed in the initial application or introduced by a Type II variation, a route written into Regulation (EC) No 1234/2008 from January 2025; ICH Q12 describes the concept. Once the protocol is approved and the agreed studies meet the acceptance criteria, the change itself is typically filed as a Type IA or IB variation instead of a Type II.
Common issues: protocols too vague for the authority to accept the criteria, changes that drift from what the protocol described so it no longer applies, and protocols that ignore effects on other sites or products.
The new pharma package (not yet in force) leaves variation categories to delegated acts and adds database updates for some changes; see variations changes.
Used in
CMC teams research the classification and data needed for a CMC change in Workbench, with cited answers from EMA and ICH.
Related terms
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- Classification guideline: Commission guideline on variation categoriesThe classification guideline is the Commission's list of variation changes, with the conditions and documents that make each one Type IA, IB or II.
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