Import of clinical trial test materials (CTM) into Singapore requires the approval of the Health Sciences Authority. Request for approval of CTM is to be made using the CTM form available from the:

Clinical Trials Branch
Pre-Marketing Division
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way #11-01 Helios
Singapore 138667

The CTM form is to be completed and submitted by the sponsor together with the application for clinical trial certificate (CTC) to the Clinical Trials Branch (CTB), Health Products Regulation Group, Health Sciences Authority.

Electronic applications for CTM can be made online via prism@hsa if the CTC application was submitted online.

For CTC applications that were submitted in hard copies, please download Application Form for CTM.

One CTM form is to be submitted for each application of CTC. That is, it is protocol specific.

The trial title, protocol number, principal investigator(s), trial institution(s) and local sponsor are to be stated in Section A. Section A is to be signed by the person (local sponsor applicant) responsible for the import.

The name, strength and estimated total quantity of the CTM to be imported for the whole trial are to be stated in Section B.

The particulars of the local importer, which could be the local sponsor are to be stated in Section C. If the sponsor is not the importer, the particulars of that importer are to be stated.

The approved CTM form will be issued to the sponsor at the same time when the corresponding CTCs are issued to the principal investigators. If the importer is different from the sponsor, it is the responsibility of the sponsor to forward the approved CTM form to the importer.

The approved CTM form is a once-off approval for the import of CTM for the whole trial and is valid till the expiry of the corresponding CTC. It will be rendered invalid upon the withdrawal or cancellation of the corresponding CTCs.

At the point of import of each consignment of CTM, the approved CTM form is to be faxed to the TradeNet officer (fax: 6478 9035) together with the import declaration to facilitate the import clearance of the consignment.

If a request for extension of the CTCs is made, a corresponding request for extension of the CTM import approval, using a new CTM form, should also be made.