Singapore legislation
Regulation 53
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 53
Certificate of manufacturing standard of CTGT products
Subregulation 1
The Authority may, on the application of a person who manufactures —
a CTGT product; or
a starting material used in the manufacture of a CTGT product, (called in this paragraph the manufacturer) and on being satisfied, after completion of an assessment of conformity, that the manufacturer conforms to an applicable Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer subject to any terms and conditions that the Authority thinks fit.
Subregulation 2
Every GMP Certificate issued is valid for the period specified in the certificate, being not longer than 3 years starting on the date of commencement of the assessment mentioned in paragraph (1).
Subregulation 3
An application for a GMP Certificate must —
be made in the form and manner specified on the Authority’s website; and
be accompanied by the relevant fee.
Subregulation 4
In this regulation, “GMP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Manufacturing Practice Standard.