Conduct of Clinical Trials under the Health Products Act and the Medicines Act

A Clinical Trial is a research study of a health product to investigate any of the following in humans:

• Discover or verify its clinical, pharmacological or pharmacodynamic effects

• Identify any adverse effect that may arise from its use

• Study its absorption, distribution, metabolism and excretion

• Ascertain its safety or efficacy

For information about the regulatory framework of clinical trials, clinical research materials and active ingredients used in its manufacturing, under the Health Products Act and the Medicines Act, visit the Health Sciences Authority (HSA) website below

• HSA: Regulatory overview of Clinical Trials.

• HSA: Guidance documents for Clinical Trials