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, applicable clinical trial regulations, ICH E6(R2) Guideline for Good Clinical Practice and Standard Operating Procedures (SOPs).
CTC regulatory roadmap
A CTC submission may be made in parallel to the submission to Institutional Review Board (IRB).
Before starting a clinical trial of a medicinal product, the local sponsor will need to apply for a CTC. If Clinical Research Material (CRM) notification is required, this should be included in the same CTC 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 CTC 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.
All clinical trial applications must be made online through PRISM (view sample online form602 KB). You can refer to our training slides on CTC application2250 KB and CRM notification1948 KB for more details.
- 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
- GMP certificate for the finished product manufacturer is required for all 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.
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.
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).