All clinical trials on medicinal products conducted in Singapore requires Clinical Trial Certificates (CTC) from the Health Products Regulation Group (HPRG), Health Sciences Authority. The Medical Clinical Research Committee (MCRC) provides advice on the licensing of clinical drug trials.
The MCRC deliberates and reviews:
- New applications for clinical trial certificates;
- Amendments to clinical trial protocols and informed consent documents;
- Serious adverse event reports; and
- Requests for CTC extension.
With the increase in clinical research activities in Singapore and the need to accord appropriate protection to ensure the safety and well-being of trial subjects, the HPRG reviewed and updated the Medicines (Clinical Trials) Regulations in April 1998 and implemented the Singapore Guideline for Good Clinical Practice (SGGCP) on 1 Aug 1998.
The SGGCP, which was adapted from the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), sets ethical and scientific standards for the conduct of clinical trials. It also serves as an assurance that results obtained from clinical trials are credible.
The Singapore Guideline for GCP can be obtained from the Health Products Regulation Group.
