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.
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:
Documents
Location in ICH CTD
Location in ACTD
Required for NDA abridged route
Administrative documents
Module 1
Part I
Yes
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
ICH CTD: No ACTD: Overview only
Clinical documents
Module 5
Part IV
Study reports of pivotal studies and synopses of all studies
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.
Refer to CTGTP fees and turnaround time for more information.
Submit your application through the relevant application form. Ensure you have the following before submitting your application:
Regulatory overview
Class 1 CTGTP notification
Register a Class 2 CTGTP
Variation applications
Dealer's notice
Dealer's licensing and certification
Risk management plan requirements
Report adverse events
Report or recall defective products
Clinical trials
Product consultation
Advertisements and promotions
Certificate of a Pharmaceutical Product
Duties And Obligations
Guidance documents
Fees and turnaround time
Notified Class 1 CTGTP
Register of Class 2 CTGTP
Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
CTGTP E-services