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, 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.

Clinical Trial Authorisation (CTA)

Documents required

  • Clinical trial protocol
  • Informed consent form (in English)
  • 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(s)1
  • Certificate of Analysis (COA) for study batches of investigational products
  • Chemistry, Manufacturing and Control (CMC) information, when requested
  • GMAC assessment outcome2, for CTGTPs or therapeutic products containing genetically-modified organisms (e.g., viral vectors)
  • Documents for CRM Notification, if applicable:
    • List of components in a medical device system
    • Packing list for study-visits specific lab kits, if products in lab kits are not declared in application form

(1) Note for GMP certificate:

  • GMP certificate for the finished product manufacturer is required for all locally unregistered investigational and auxiliary products used in the clinical trial.
  • For biologics and Class 2 CTGTPs, 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

(2) Note for GMAC assessment outcome:

  • An Environmental Risk Assessment (ERA) application must be submitted to the Genetic Modification Advisory Committee (GMAC) for CTGTPs or therapeutic products containing genetically-modified organisms (GMOs) (e.g., viral vectors). For details on the application, please refer to the GMAC website under the section 'Release of GMO-related Health Products'.
  • As GMAC's review of the application may take approximately 6 months to complete, we recommend factoring this timeline into your planning for the clinical trial application to HSA.
  • If the GMAC assessment outcome is not yet available when submitting your clinical trial application to HSA, please indicate this in your submission and commit to providing the GMAC outcome to HSA once available.

Turn-around-time 

Standard turn-around-time: 30 working days

Note:

  • Acknowledgement email for CRM notification will be sent immediately upon submission. Upon receipt, CRM importers and local manufacturers may proceed to import or supply the CRM.
  • Turn-around-time for phase 1 studies solely assessing bioequivalence, bioavailability, food effect or drug-drug interactions is 15 working days.
  • Turn-around-time for studies involving CTGTPs is 60 working days.

Clinical Trial Notification (CTN)

Documents required

  • Clinical trial protocol
  • Informed consent form (in English)
  • 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 applicable:
    • List of components in a medical device system
    • Packing list for study-visits specific lab kits, if products in lab kits are not declared in the application form

Turn-around-time 

Standard turn-around-time: 5 working days

Note:

  • Acknowledgement email for CRM notification will be sent immediately upon submission. Upon receipt, CRM importers and local manufacturers may 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).