Reply To: Annex VI Grace Period
January 27, 2022 at 4:18 pmThe 3-year grace period applies to ongoing studies that were submitted under the CTD.
If a study is submitted under the CTR, then all study elements must comply with the CTR.
There is, however, a 12-month grace period (until 31Jan2023) that studies can still be submitted under the CTD. If that study will complete before 31Jan2025 then that study can continue under the CTD.