A/B
Compare markets
Pick two to four markets to compare stages and key dates side by side. The link is shareable (?m= parameter).
| Market | Stage | Technical pilot | Voluntary | Mandatory | Mandatory scope |
|---|---|---|---|---|---|
| United States | Voluntary | 2022 – Q2 2023 (complete) · forward compatibility supported from 16 Oct 2026 | 2024 | 2029 ICH roadmap | NDA, ANDA, BLA, commercial IND, DMF |
| European Union | Voluntary | 2024 (CAPs complete) · 2026 forward compatibility (ongoing) | 2025-12-22 (new MAA CAPs) · MRP/DCP/NP TBD | 2028 · new MAA CAPs (strongly recommended from 2027) ICH roadmap | New marketing authorisation applications (CAPs) |
| Australia | Piloting | Started H2 2025 (ongoing · per TGA) | 2029 (per ICH table) | TBD No official date | TBD |
| Japan | In force | Q2 2021 (complete) | 2022 | April 2026 Authority confirmed | NDA and some sNDA; ANDA optional |