Singapore implements new regulations for cell, tissue, and gene therapy products (CTGTP). The regulations take effect from 1 March 2021.
According to the Health Products (Cell, Tissue, and Gene Therapy Products) Regulations 2021, CTGTP is health products intended for use in humans for a therapeutic, preventive, palliative, or diagnostic purpose. CTGTP can contain any of the following and achieves its primary intended action by pharmacological, immunological, physiological, metabolic, or physical means:
In Singapore, CTGTP is risk-stratified into two classes below:
Class 1 CTGT product” means a CTGT product that —
Class 2 CTGT product” means a CTGT product other than a Class 1 CTGT product;
The regulations stipulate provisions relating to manufacturing, import, supply, presentation and registration, duties, and obligations of manufacturers, importers, and export certification of CTGTPs.
To continue reading this article please go to Pharma to Market .
Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021