Regulatory Requirements for Clinical Trials of TPs and Class 2 CTGTPs
Regulatory Requirements for Clinical Trials of TPs and Class 2 CTGTPs
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
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