Singapore legislation
Regulation 50
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 50
Submission of benefit-risk evaluation reports
Subregulation 1
The Authority may require any registrant of a CTGT product to submit, within the period specified by the Authority, a benefit‑risk evaluation report relating to the CTGT product.
Subregulation 2
Where the Authority has not specified any period within which a benefit‑risk evaluation report is required to be submitted, a registrant of a CTGT product who is required by the Authority to submit that report must submit the report —
for an initial period of 2 years, at intervals of 6 months commencing from either the date of registration of the CTGT product, or its international birth date, whichever is earlier; and
for the next 3 years, annually.
Subregulation 3
A person who fails to provide a benefit-risk evaluation report —
as required by the Authority under paragraph (1); or
within the period stipulated under paragraph (2),shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Subregulation 4
In paragraph (2)(a), “international birth date”, for a CTGT product, means the date of the first marketing approval granted to any person for the sale of the CTGT product in any country in the world.