Singapore legislation
Regulation 21
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 21
Certificate of manufacturing standard of clinical research materials
Subregulation 1
The Authority may, on the application of —
a manufacturer of any clinical research material; or
a manufacturer of a starting material used in the manufacture of clinical research material that is a CTGT product,and on being satisfied, after completing 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 as the Authority thinks fit.
Subregulation 2
Every GMP Certificate issued is valid for a 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 —
Definition
“GMP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Manufacturing Practice Standard;
Definition
“Good Manufacturing Practice Standard” means any of the following as shown on the Authority’s website:
for therapeutic products —
the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products; or
any other good manufacturing practice standard approved by the Authority;
for CTGT products —
the Good Manufacturing Practice Standard for CTGT products issued by the Authority; or
any other good manufacturing practice standard that is approved by the Authority.