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New Clinical Trial Authorisation (CTA) or Clinical Trial Notification (CTN) submission

Understand the application requirements, including the supporting documents and turn-around-time, for your CTA or CTN application.

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.

A CTA is intended for clinical trials of a locally unregistered therapeutic product, or an unapproved use of a locally registered therapeutic product (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 intended for a clinical trial that involves only locally registered therapeutic products used in accordance with its local approved label. CTN submissions are subjected to a simplified screening and verification process with a significantly shorter regulatory processing time.

All clinical trials of a therapeutic product 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 is it used A trial investigating one or more locally unregistered therapeutic products or an unapproved use of a locally registered product. A trial of one or more locally registered therapeutic products used in accordance with its local approved label.
Turnaround time 30 working days, or 15 working days for Phase 1 studies solely to evaluate bioequivalence, bioavailability, food effect or drug-drug interactions. 5 working days.

All clinical trials must be conducted in compliance with the protocol, applicable clinical trial regulations, ICH E6(R2) Guideline for Good Clinical Practice and Standard Operating Procedures (SOPs).

CTA-CTN regulatory roadmap

While a CTA submission may be made in parallel to the submission to Institutional Review Board (IRB), 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 a CTN. If Clinical Research Material (CRM) notification is required, this should be included in the same CTA or CTN application. The proposed CRM quantity should be a realistic estimate of what is required.

Upon completing the application draft, the local sponsor representative will notify the relevant parties to endorse the application as the Principal Investigator, other sponsor (for investigator-initiated studies with more than one local sponsor) and CRM importer or local manufacturer. Once the endorsement process is completed, the local sponsor representative can proceed to submit the application to us.

Once the CTA or CTN is issued, it 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 form602 KB). You can refer to our training slides on CTA/CTN application2250 KB and CRM notification1948 KB for more details.

Clinical Trial Authorisation (CTA)

Documents required

  • Clinical trial protocol
  • English Informed consent form
  • Investigator's brochure for locally unregistered products
  • Approved product label for locally registered products
  • List of overseas trial sites (where applicable)
  • Principal investigator's CV
  • Good Manufacturing Practice (GMP) certificate
  • Certificate of Analysis (COA) for study batches of investigational products
  • Chemistry, Manufacturing and Control (CMC) information, when requested
  • Documents for CRM Notification (if required):
    • List of components in a medical device system
    • Packing list for study-visits specific lab kits

Note:

  • GMP certificate for the finished product manufacturer is required for all locally unregistered investigational and auxiliary products used in the clinical trial.
  • For biological and biotechnology products, GMP certificate for the drug substance manufacturer should also be submitted.
  • If the GMP certificate is not available for the following products, the sponsor can submit a declaration to state that the product is manufactured in compliance with current GMP standards and sourced from an authorised manufacturer in the country of origin (i.e. a manufacturer approved by the regulatory authority of the country of origin). This applies to:
    • Products not locally registered but registered overseas
    • Locally-registered products not sourced from the same manufacturer in the product registration

Turnaround time 

Standard Turnaround time: 30 working days

Note:

  • Acknowledgement for CRM notification will be sent immediately upon submission. Upon receipt, CRM importers and local manufacturers can proceed to import or supply the CRM.
  • Turnaround time for phase 1 studies solely assessing bioequivalence, bioavailability, food effect or drug-drug interactions is 15 working days.

Clinical Trial Notification (CTN)

Documents required

  • Clinical trial protocol
  • English informed consent form
  • List of overseas trial sites (where applicable)
  • Principal investigator's CV
  • Approved product label for locally registered products
  • IRB approval letter
  • Documents for CRM Notification (if required):
    • List of components in a medical device system
    • Packing list for study-visits specific lab kits

Turnaround time 

Standard Turnaround time: 5 working days

Note:

  • Acknowledgement for CRM notification will be sent immediately upon submission. Upon receipt, CRM importers and local manufacturers can proceed to import or supply the CRM.

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).

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