Before any clinical trials on medicinal products can be conducted, the doctor conducting the trial (also known as a clinical investigator) must obtain both ethics and regulatory approvals before initiating the study.

Conduct of clinical trials in Singapore is regulated by the Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998. In addition, the Singapore Guideline for Good Clinical Practice (GCP) has to be observed in the conduct of local clinical trials.

The Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998 can be purchased from SNP Corporation Ltd (Legal Publications):

1 Kim Seng Promenade #18-01
Great World City East Tower
Singapore 237994
Tel (65) 6826-9600
Fax (65) 6820-3341
Email: legalpub@snpcorp.com
Website: http://www.snpcorp.com/

The Singapore Guideline for GCP can be obtained from the Centre for Drug Administration (CDA).

The Health Sciences Authority (HSA) issues the regulatory approval, in the form of a Clinical Trial Certificate (CTC) to the clinical investigator. The CTC is issued in the name of the principal investigator. It is specific for each study protocol, and for each institution or site involved in the study.

Each CTC is valid for a period of two years unless otherwise stated.

If a trial is not completed upon the expiry of the CTC, the sponsor has to make a written request for an extension of the CTC and submit an interim clinical trial status report to support the request. Both of these online applications can be made via prism@hsa.

With effect from January 2006, parallel submissions can be made to both the HSA and to the respective Institutional Review Board/ Domain Specific Review Board. The regulatory approval would be issued independent to the ethics approval. The applicants should initiate the study only when both regulatory and ethics approvals have been obtained.

Applications for CTC are to be made by the sponsor, which should be a locally registered company. Only one application is required for multi-centre clinical trials on the same drug using the same trial protocol to be conducted at two or more local institutions.

Electronic applications for CTC can be made online via prism@hsa. The application form and supporting trial documents can be submitted online without the need of manually submitting multiple sets of the hard copies. For all users (principal investigators and sponsors) of Clinical Trials e-Services via prism, an electronic authentication system with SingPass is utilised. As such no physical signatures are needed to transact application services via prism.

Further information on the electronic application system can be found in the Overview of the Electronic Application Process for CTC and the User Manual for PRISM Internet CTC Module (file size: 2.24MB).

Hard copy submission of application for CTC should only be made when access to the online application is not available. Hard copy applications for CTC are to be submitted under confidential cover by the sponsor to the following address:

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

Download hard copy Application Form for CTC.

A complete set of application dossier will comprise of the completed application form and a properly labeled set of supporting documents as required in Section 8 of the application form.

The original set of application dossier that is, bearing the original declaration (signature) of the principal investigator(s) and sponsor has to be submitted for each application for CTC. In addition, the original application dossier has to be submitted in 5 duplicated sets for each application for CTC.

Enquiries related to CTC application can be made to:

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

Tel No. 6866-3446, Fax No. 6478-9034