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Regulatory Requirements for Clinical Trials of TPs and Class 2 CTGTPs

Learn the regulatory requirements for clinical trials of Therapeutic Products and Class 2 Cell, Tissue and Gene Therapy Products.

Last updated 24 May 2026

This module on the regulatory requirements for clinical trials of Therapeutic Products and Class 2 Cell, Tissue and Gene Therapy Products covers the following:

Scope of Clinical Trials Regulated Under the Health Products (Clinical Trials) Regulations
Risk-Based Regulation of Clinical Trials
Sponsor and Principal Investigator Responsibilities
Clinical Trials Register

Version date: 28 Jul 2025
(Click here to download the slide deck [PDF, 761 KB])

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