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Clinical trials of therapeutic products

Find out the regulatory requirements for clinical trials of therapeutic products regulated under the Health Products Act.

Regulatory overview Understand the regulatory framework of clinical trials and clinical research materials. New CTA or CTN submission Understand the application requirements, including the supporting documents and turn-around-time for your new clinical trial application for therapeutic products. Subsequent submissions Find out when you need to make a subsequent submission during and after the clinical trial. Good Clinical Practice Inspections Understand the processes for preparation, conduct and follow up of Good Clinical Practice Inspections. Report adverse events Understand the requirements for expedited safety reporting in therapeutic and medicinal product clinical trials. Product consultation Seek early scientific and regulatory advice on therapeutic product development with our Innovation Office. Conducting clinical trials Understand the roles and responsibilities of the study staff involved in conducting a clinical trial. 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.

Last updated: 31 Dec 2018