Clinical trials

Regulatory overview of clinical trials

Understand 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.

CTA, CTN or CTC submissions

Understand what to submit to us for a clinical trial.

Submit a Clinical Research Materials notification

Understand the application process and required documents for your Clinical Research Material notification.

Good Clinical Practice Inspections

Understand the processes for preparation, conduct and follow up of Good Clinical Practice Inspections.

Adverse events reporting in clinical trials

Understand the requirements for safety reporting in clinical trials.

Innovation Office (Therapeutic Products and Cell, Tissue and Gene Therapy Products)

Seek early scientific and regulatory advice on therapeutic product and cell, tissue and gene therapy product development.

Conducting clinical trials

Understand the basics of conducting clinical trials, including the responsibilities of PI and sponsor, direct access requirements, informed consent, IP management and maintaining essential records.

Participating in clinical trials

Understand the possible benefits, risks and your rights as a participant should you decide to participate in a clinical trial.

Guidance documents for clinical trials

Here is a list of regulatory guidances to help you understand the regulatory requirements for conducting clinical trials.

IOCTB Learn

Clinical Trials Learning and Educational Hub.

Clinical Trials Register

Get the latest information on active clinical trials.

Clinical trials statistics

Get the annual or trend statistics related to regulated clinical trials.