New Clinical Trial Certificate (CTC) submission

When to submit a CTC

A CTC is required prior to the initiation of a clinical trial intended to investigate one or more medicinal products for the treatment or prevention of diseases.

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).

CTC regulatory roadmap

A CTC submission may be made in parallel to the submission to Institutional Review Board (IRB).

Application process

Before starting a clinical trial of a medicinal product, the local sponsor will need to apply for a CTC. “Local sponsor” refers to the local company or local institution which takes responsibility for the initiation, management or financing of the clinical trial. Refer to Conducting clinical trials: Sponsor for more information on sponsor responsibilities.

If a Clinical Research Material (CRM) notification is required, this should be included in the same CTC 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 may proceed to submit the application to us.

The CTC 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 form [DOC, 635 KB]). You can refer to our training slides on CTC application [PDF, 2.3 MB] and CRM notification [PDF, 2.1 MB] for more details.

Documents required

• Clinical trial protocol

• 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 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*: 30 working days

*Turn-around-time is calculated based on working days and excludes ‘stop-clock time’ for clarification requests and additional information.

Note: Acknowledgement email 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:

• CRIS company account

• Corppass or HSA PIN

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).