Variation applications for registered CTGTP

Submit a variation application to us when there is a change to your registered CTGTP's safety, efficacy or quality information. 

Variation types

There are three types of variation applications for a registered CTGTP. All variation applications require approval before changes can be implemented.

  • Major variation 1 (MAV-1) application
  • Minor variation (MIV-1 and MIV-2) applications

MAV-1

Major variation 1 application (MAV-1)

Any variation that involves:

  • 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.

Prepare your MAV-1 application

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:

MIV-1 and MIV-2

Minor variation applications

Any variation that is specified under the MIV Checklist for Class 2 CTGTP379 KB, where:

  • Part A refers to an MIV-1 application
  • Part B refers to an MIV-2 application

Prepare your MIV applications

Organising your applications

At any one time, you may submit up to four concurrent MIV-1 applications and only one MIV-2 application for each registered CTGTP.

If there are multiple changes, follow the guide below to organise your submission(s):

Change category  Submission options 
MIV-1 only

MIV-1 changes should be grouped and submitted as one MIV-1 application if the changes are consequential. A consequential change is an unavoidable and direct result of another change e.g. a change of specifications is consequential to a change of manufacturing process.

Grouping of non-consequential MIV-1 changes under one application is not allowed. You will be requested to withdraw and resubmit separate applications.
MIV-2 only Multiple MIV-2 changes can be bundled in one MIV-2 application.
MIV-1 and MIV-2 If your variation involves an MIV-1 change and an MIV-2 change, you can bundle both changes and submit as one MIV-1 application.

Submission requirements

You will need to submit the following in your online application:

  • Table of contents
  • Cover letter
  • Table of summary of changes which must include all of the following:
    • Section(s) of the original dossier affected by the change(s) 
    • Approved and proposed condition(s)
    • Reason(s) for the change(s)
    • Registration status and date of approval of the proposed change(s) in other countries/agencies
  • Relevant MIV Checklist for Class 2 CTGTP379 KB and their specified supporting documents

You need to disclose all proposed changes in the Table of summary of changes. Any undisclosed variation embedded in the submitted data, or any follow-on changes not requested, will not be considered for evaluation.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your applications through SHARE.

Ensure you have the following before doing so:

  • CRIS company account and note your client code for billing
  • Corppass