Regulatory Oversight of Cell, Tissue, and Gene Therapy Products in Singapore.

Abstract

The Health Sciences Authority of Singapore has implemented a fit-for-purpose regulatory framework for Cell, Tissue, and Gene Therapy Products (CTGTPs) on 1 March 2021. A total of 11 pieces of subsidiary legislation for CTGTP are gazetted under the Health Products Act as Health Products (CTGTP) Regulations 2021. The CTGTPs are stratified into lower-risk Class 1 CTGTP or moderate- to higher-risk Class 2 CTGTP based on their degree of manipulation, intended use, and if they are combined or used with therapeutic products or medical devices. The regulatory controls are calibrated to the different risk profiles of the products. This risk-based regulatory approach aims to facilitate successful product development and registration in Singapore for innovative CTGTP with a least burdensome regulatory framework while ensuring reasonable safeguards on the safety, quality, and efficacy of the products. This chapter describes the regulatory oversight of CTGTP in Singapore.