Singapore legislation
Regulation 4
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 4
Manufacturing minimally manipulated CTGT products
Subregulation 1
For the purposes of section 12(1) of the Act, a manufacturer’s licence is not required for the manufacture of a CTGT product that is a result of only minimal manipulation of cell or tissue if carried out by a person —
who is the holder of a manufacturer’s licence for any CTGT product;
who is manufacturing the CTGT product not for any supply to the public but solely for —
the purpose of scientific education or research and development; or
a non‑clinical purpose; or
who gives or has given notice to the Authority in accordance with paragraph (2) in relation to a CTGT product that is a result of only minimal manipulation of cell or tissue and that notice is not refused, withdrawn or cancelled under these Regulations.
Subregulation 2
The notice required by paragraph (1)(c) for a CTGT product that is a result of only minimal manipulation of cell or tissue must —
be in the form and manner specified on the Authority’s website;
be accompanied by the following information in writing:
the particulars of the person giving the notice as required by the Authority; (ii)a description of the CTGT product to which the notice relates;
a statement of the manufacture involved;
the premises where the manufacture is to be carried out; and
be accompanied by the relevant fee.