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Major variation 1 (MAV-1) application for CTGTP

Follow this guide to change the approved indication, dosing regimen, patient group, or clinical information to extend the usage of your registered cell, tissue or gene therapy products (CTGTP).

Overview

A MAV-1 application for a registered CTGTP is:

  • Any variation that involves:
    • Change(s) to the approved indication, dosing regimen or patient group(s).
    • Inclusion of clinical information extending the usage of the product e.g. clinical trial information related to an unapproved indication, dosing regimen or patient population.
  • Requires prior approval before the change(s) can be implemented

Evaluation routes

There are two evaluation routes for a MAV-1 application, with different eligibility criteria and documentary requirements:

Evaluation route Eligibility
Full A variation that has not been approved by any comparable overseas regulator at the time of submission. 
Abridged

A variation that has been evaluated and approved by at least one of our comparable overseas regulators. 

The proposed variation – i.e. the proposed indication(s), dosing regimen(s), patient group(s) and/or clinical information – should be the same as that approved by the comparable overseas regulator that issued the proof of approval.

Application guide

Once you have decided on an evaluation route for your MAV-1 application, you may proceed to our application guide for the steps and documents required to complete your registration.

Full evaluation route Follow this guide for the documentary requirements, fees and turnaround time of the MAV-1 application via the full evaluation route for CTGTP. Abridged evaluation route Follow this guide for the documentary requirements, fees and turnaround time of the MAV-1 application via the abridged evaluation route for CTGTP.
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