Established conditions (ECs)

In ICH Q12, the legally binding elements of an approval considered necessary to assure product quality, so that changing them requires a regulatory submission. Japan implemented ICH Q12 through its guideline on technical and regulatory considerations for pharmaceutical lifecycle management (PSEHB/PED Notification No. 1029-1 and PSEHB/PSD Notification No. 1029-1, October 29, 2021). A 2026 PMDA notice explains that process parameters identified as ECs, meaning critical process parameters and other parameters whose impact on quality cannot reasonably be excluded, are described in the manufacturing method section of the Japanese application. That section already marks which items need a partial change application and which a minor change notification.