Singapore legislation
Regulation 6
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 6
Requirements for manufacturer’s licence for CTGT products
For the purposes of section 24(2)(a)(i) of the Act, an applicant for a manufacturer’s licence for the manufacture of a CTGT product that is not a result of only minimal manipulation of cell or tissue must be able —
to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for all of the following:
carrying out the manufacture of the CTGT product to be authorised by the licence;
the proper handling, storage and distribution of the CTGT product so as to prevent the deterioration of the CTGT product while it is in the applicant’s ownership, possession or control;
to conduct all manufacturing operations in such a way as to ensure that the CTGT product is of the correct identity and conforms with the applicable standards of quality for that CTGT product; and
to comply with the Good Manufacturing Practice Standard in relation to the manufacture of the CTGT product.