Singapore legislation
Regulation 14
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 14
Dealing with clinical research materials
Subregulation 1
This regulation applies to any clinical research material manufactured in, imported into, or supplied in, Singapore under regulation 3.
Subregulation 2
Without prejudice to regulation 9, a person must not use the clinical research material in any clinical research, and the sponsor must ensure that no person involved in the research uses the material —
except in accordance with the protocol for the research; and
where the research requires the approval of an institutional review board, only after the approval has been obtained.
Subregulation 3
Despite paragraph (2) —
the clinical research material need not be used as referred to in paragraph (2) if the Authority has allowed some other use of the material; and
the sponsor must ensure that the material is put to the other use.
Subregulation 4
To avoid doubt, as from the time that the Authority has allowed the other use under paragraph (3) —
the clinical research material in question ceases to be clinical research material; and
nothing in these Regulations prevents the clinical research material which ceases to be such, from being subject to any law relating to therapeutic products or CTGT products.
Subregulation 5
Unless the Authority otherwise allows, the sponsor must ensure that, within 6 months of the conclusion or termination of the clinical research, any unused clinical research material obtained for the research is disposed of or (subject to regulation 6 in relation to any material that contains any psychotropic substance) exported.
Subregulation 6
In paragraph (5), “unused clinical research material” means any clinical research material referred to in paragraph (1) which is not used in the clinical research for which the material was obtained (including where the material cannot or can no longer be used in the research).