Abridged evaluation route MAV-1 application guide

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

Eligibility

You may submit a MAV-1 application via the abridged evaluation route if the variation has been evaluated and approved by at least one of our comparable overseas regulators.

The proposed variation submitted to us should be the same as that approved by the regulatory agency that issued the proof of approval.

Submission requirements

Application dossier

You must submit the application dossier within 2 working days of the application and organise it in either an International Council for Harmonisation Common Technical Document (ICH CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.

Your application dossier must be submitted to us in a CD/DVD labelled with the following information:

  • Product name.
  • Application type.
  • Contents of the CD/DVD (e.g. Module 1).
Documents Location in ICH CTD Location in ACTD Required for MAV-1 abridged evaluation route
Administrative documents and product information Module 1 Part I Yes
Common technical document overview and summaries Module 2 Incorporated into Parts II, III and IV Yes
Quality documents Module 3 Part II No
Non-clinical documents Module 4 Part III Non-clinical overview only, if applicable
Clinical documents Module 5 Part IV Study report(s) of pivotal studies and synopses of all studies (phase I-IV) relevant to requested indication, dosing and/or patient group

Application checklists

Each application must be accompanied by an application checklist, completed by the applicant and attached in the online application form.

Use one of the following application checklists for your CTD format. Each checklist provides details on the specific documents that need to be submitted with your application.

Fees and turn-around-time

Refer to CTGTP fees and turn-around-time for more information.

How to apply

Submit your application through the relevant application form. Ensure you have the following before submitting your application: