Post-Approval Change Management Protocol(PACMP)의 산업계 적용 사례 분석: 글로벌 제약기업 사례를 중심으로

초록

This study evaluated the regulatory impact and limitations of the Post-Approval Change Management Protocol (PACMP), introduced in ICH Q12, through analysis of industrial case studies. Nine cases of PACMP application were selected from official regulatory documents and public industry presentations. The cases included manufacturing site changes, raw material and process changes, analytical procedure changes, and shelf-life extension. Both single-regulator pilots and ICMRA multi-regulator collaborative assessment pilots were analyzed, comparing each case by regulatory jurisdiction, change type, reporting category changes, and review timeline. The analysis showed that PACMP's effects varied by change characteristics. For changes with long data-generation periods and high regulatory complexity, meaningful regulatory efficiency gains were observed: in a singleregulator pilot, the typical 12-month prior approval review was reduced to approximately three months, while a multi-regulator collaborative pilot reported an approximately five-month reduction. Some cases further demonstrated PACMP's potential as an extended change management framework applicable across multiple products and sites. In contrast, for changes with short data-generation periods such as analytical procedure changes, PACMP's benefits were limited. These findings suggest PACMP's effects vary by change type, and effective implementation requires strategic application supported by a mature Pharmaceutical Quality System (PQS) and regulatory cooperation frameworks.

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