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Health Sciences Authority

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 on 31 October 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] (opens in new tab))

Thumbnail for IOCTB Learn - Regulatory Requirements for Clinical Trials of TPs and Class 2 CTGTPs

Note: With effect from 1 Nov 2026,

  • The Innovation Office and Clinical Trials Branch (IOCTB) will be renamed Investigational Medicines and Non-Clinical Assessments Division (IMNAD).

  • IOCTB Learn will be renamed Clinical Trials Learn. Previously published slides and videos will retain the former names.