Singapore legislation
Regulation 22
Regulation 22
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 therapeutic product, if the Authority is satisfied —
(a)
that the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with the use of the therapeutic product; and
(b)
based on the formulation, manufacturing process controls, specifications and shelf life of the therapeutic product, and the stability of the therapeutic product under the recommended storage conditions, that the therapeutic product is suitable for its intended purpose and that any risk associated with its use is minimised.