ICH M7 EWG Sub-Group Work Plan October 01, 2024
1.c. Future anticipated key milestones
| Expected future completion date | Milestone |
|---|---|
| Mar. 2025 | Final concept paper |
| Mar. 2026 | Stage 1 Topics Step 1 –Sign off by topic leaders |
| Mar. 2027 | Stage 2 Topics Step 1 – Sign off by topic leaders |
| Apr. 2027 | Stage 1 & 2 Topics Step 2a/b – Endorsement |
| May. 2027 | Step 3 Draft addendum (Stage 1 and 2 topics) released for comment – allow 6 months (end November 2027) |
| Apr. 2028 | Step 3 Discussion of regional consultation comments and editing of draft addendum (Stage 1 and 2 topics) |
| Apr. 2028 | Finalization of Step 3 experts draft addendum and Sign off (ICH Reg Members) |
| May. 2028 | Step 4 – Adoption by ICH Assembly |
| Nitrosamine Monograph drafting to start subsequent to Addendum reaching Step 4 |
It’s a long journey for us… 