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:
- viable or non-viable human cells or tissues
- viable animal cells or tissues
- recombinant nucleic acids
In Singapore, CTGTP is risk-stratified into two classes below:
Class 1 CTGTP (lower risk)
Class 2 CTGTP (higher risk)
Class 1 CTGT product” means a CTGT product that —
(a) is the result of only minimal manipulation of human cell or tissue;
(b) is intended for homologous use;
(c)is not combined or used with —
(i)a health product categorized as a therapeutic product in the First Schedule to the Act; or
(ii)a health product categorized as a medical device in the First Schedule to the Act; and
(d)is assigned by the Authority as a Class 1 CTGT product due to a lower health risk to a user of the product;
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.
Please refer to the link below for further information
Link to:
Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021