Singapore legislation
Regulation 29
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 29
Requirements for registration
For the purposes of section 30(2)(a)(iii) of the Act, the Authority may, after carrying out an evaluation under section 33 of the Act, register a Class 2 CTGT product, if the Authority is satisfied —
that the overall intended benefits to a patient to whom the CTGT product is administered outweigh the overall risks associated with the administration of the CTGT product; and
based on the formulation, manufacturing process controls, specifications and shelf life of the CTGT product, and the stability of the CTGT product under the recommended storage conditions, that the CTGT product is suitable for its intended purpose and that any risk associated with its administration is minimised.