Japanese–English glossary
Post-approval change management protocol (PACMP)
Also called change plan confirmation (Japan)
承認後変更管理プロトコルshōningo henkō kanri purotokoru
A plan, agreed with the regulator in advance, that describes a future change, the studies that will support it and the acceptance criteria, so the change can later be made with a lighter filing. The concept comes from ICH Q12. Japan introduced it through the 2019 amendment of the PMD Act as the confirmation of a change plan (変更計画の確認), in force since August 1, 2021. The Minister confirms the plan beforehand, and a change carried out as planned is filed by notification instead of a partial change application. PMDA had run a PACMP pilot from April 2018. The route suits predictable changes such as a site addition, a scale-up or a supplier switch.