Abridged evaluation route registration guide

Follow this guide on the documentary requirements, fees and turn-around-time to register your cell, tissue or gene therapy products (CTGTP) via the abridged evaluation route.


You can register your CTGTP via the abridged evaluation route if it has been approved by at least one of our comparable overseas regulators at the time of submission. 

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).


Location in ICH CTD

Location in ACTD

Required for NDA abridged route

Administrative documents

Module 1

Part I


Common technical document overview and summaries

Module 2

Incorporated in Parts II, III and IV


Quality documents

Module 3

Part II


Non-clinical documents

Module 4

Part III

ACTD: Overview only

Clinical documents

Module 5

Part IV

Study reports of pivotal studies and synopses of all studies

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 based on your choice of CTD format. Each checklist provides details on the specific documents that need to be submitted with your application.

Note: Your choice of CTD  format submitted for NDA will determine the submission format for the rest of your product life cycle. This means that future applications for changes to your registered product (variation application) will have to be in the same CTD format.

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: