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Health Sciences Authority

Major variation-1 (MAV-1) applications

Understand the requirements to change the clinical usage of your registered Class 2 CTGTP including the indication, dosage regimen or patient group.

Last updated 25 March 2026

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: 

List of evaluation routes

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.

Comparable overseas regulators

HSA's comparable overseas regulators consist of the following:

  • Australia Therapeutic Goods Administration (TGA)

  • Health Canada (HC)

  • US Food and Drug Administration (FDA)

  • European Medicines Agency (EMA)

  • UK Medicines and Healthcare Products Regulatory Agency (UK MHRA)

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:

Your application dossier must be organised in the same ICH CTD/ACTD format submitted in the original NDA for your CTGTP registration.

All documents must be in English. For documents which are not in English, a certified translation is acceptable. 

HSA may notify the applicant to withdraw and resubmit the application under a more appropriate variation type, where necessary. Screening fees paid for MAV-1 applications are non-refundable and non-transferable to application resubmissions.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your applications through SHARE.