Major variation-1 (MAV-1) application
Understand the requirements to change the clinical usage of your registered Class 2 CTGTP including the indication, dosage regimen or patient group.
About MAV-1
You must submit an MAV-1 application for your registered Class 2 CTGTP if there are:
- Change(s) to the approved indication, dosing regimen or patient group(s) OR
- Inclusion of clinical information extending the usage of the CTGTP e.g. clinical trial information related to an unapproved indication, dosing regimen or patient population.
Evaluation routes
There are two evaluation routes for an MAV-1 application with different documentary requirements, fees and evaluation turnaround times:
| Evaluation route |
Conditions |
| Full |
A variation that has not been approved by any of HSA's comparable overseas regulators at the time of submission.
Like for NDA, pre-submission notification is required for this route.
|
| Abridged |
The proposed variation is the same as that evaluated and approved by at least one of HSA's comparable overseas regulators at the time of submission.
|
Submission requirements
At any one time, you may submit up to three concurrent MAV-1 applications for each registered CTGTP.
Each application must be accompanied by a completed application checklist with the relevant specified documents:
Fees and turnaround time
Refer to CTGTP fees and turnaround time for more information.
How to apply
Submit your applications through SHARE.