When to submit a CTA or CTN
A CTA or CTN is required prior to the initiation of a clinical trial of a therapeutic product, or a Class 2 cell, tissue and gene therapy product (CTGTP).
A CTA is required for clinical trials of a locally unregistered therapeutic product or Class 2 CTGTP, or an unapproved use of a locally registered therapeutic product or Class 2 CTGTP (e.g. use for a new indication, in a new population, or of a new route of administration or dosing regimen).
On the other hand, a CTN is submitted for a clinical trial that involves only locally registered therapeutic products or Class 2 CTGTPs used in accordance with its local approved label. CTN submissions undergo a simplified screening and verification process with a significantly shorter regulatory processing time.
All clinical trials of a therapeutic product or a Class 2 CTGTP in healthy volunteers will require a CTA, unless the therapeutic product has been approved for use in healthy individuals (e.g. the product is a vaccine that is typically intended to be given to healthy individuals), and is used in accordance with the local approved label.
The table below compares the differences between CTA and CTN:
|
CTA |
CTN |
| When does it apply |
A trial investigating one or more locally unregistered therapeutic products or Class 2 CTGTPs, or unapproved use of a locally registered product. |
A trial of locally registered therapeutic products or Class 2 CTGTPs used in accordance with their local approved labels. |
| Turn-around-time |
30 working days, or 15 working days for Phase 1 trials solely to evaluate bioequivalence, bioavailability, food effect or drug-drug interactions.
60 working days for Class 2 CTGTP trials.
|
5 working days. |
All clinical trials must be conducted in compliance with the protocol, the Clinical Trial Regulations, the principles of Good Clinical Practice and applicable Standard Operating Procedures (SOPs).
CTA-CTN regulatory roadmap
While a CTA submission may be made in parallel to the Institutional Review Board (IRB) submission, a CTN submission should only be made after receiving IRB approval.
Application process
Before starting a clinical trial, the local sponsor will need to apply for a CTA or submit a CTN. If a Clinical Research Material (CRM) notification is required, this should be included in the CTA or CTN application. The stated CRM quantity should reflect the actual or a realistic estimate of the quantity required.
Upon completing the application draft, the local sponsor representative will notify the relevant parties (e.g., the Principal Investigator, the other Sponsor(s) for investigator-initiated studies with more than one local sponsor, the CRM importer or local manufacturer, if applicable) to endorse the application. Once endorsement has been completed by the relevant parties, the local sponsor representative can proceed to submit the application to us.
The CTA or accepted CTN will remain valid for the duration of the trial. The CRM notification will also remain valid for the duration of the trial.
There are no fees involved for clinical trial applications.
Application requirements
All clinical trial applications must be made online through PRISM (view sample online form634 KB). You can refer to our training slides on CTA/CTN application2270 KB and CRM notification1938 KB for more details.
How to apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).