No. S 336
Medicines Act
Medicines (Medicinal Products as
Clinical Research Materials) Regulations 2016
In exercise of the powers conferred by sections 18, 34, 44 and 74 of the Medicines Act, the Minister for Health makes the following Regulations:
Citation and commencement
1.  These Regulations are the Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016 and come into operation on 1 November 2016.
2.  In these Regulations, unless the context otherwise requires —
“appropriate non‑proprietary name”, in relation to an active ingredient of a medicinal product, means —
(a)the name or synonym of the active ingredient described in the relevant monograph appearing in the latest edition of any of the following publications:
(i)the British Pharmacopoeia;
(ii)the European Pharmacopoeia;
(iii)the United States Pharmacopoeia and the National Formulary;
(b)where the active ingredient is not described in a monograph in any such publication, its international non‑proprietary name; or
(c)where paragraph (a) or (b) is not applicable, the accepted scientific name or other name descriptive of the true nature of the active ingredient;
“Authority’s website” means the Authority’s Internet website at;
“auxiliary CRM” means any clinical research material that is used for the needs of any clinical research as described in the protocol, but not as the material to be tested or used as a reference in the research;
“clinical research” means any research involving human beings (whether or not a regulated clinical trial);
“clinical research material” means any medicinal product or placebo, that is not specified in the First Schedule, that is manufactured, assembled, imported or supplied for the purpose of being used in any clinical research by way of administration to a subject in accordance with the protocol for the research;
“institutional review board” means an independent body which —
(a)is constituted of medical, scientific, and non‑scientific members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of subjects by, among other things, reviewing, approving and providing continuing review of the protocol, amendments, and the methods and materials to be used in obtaining and documenting informed consent of the subjects; and
(b)when Part 4 of the Human Biomedical Research Act 2015 (Act 29 of 2015) comes into operation, is appointed under that Act;
“investigational CRM” means any clinical research material that is to be tested or used as a reference in any clinical research;
“proprietary name” means a word or words used in connection with the supply of a medicinal product for the purpose of indicating that it is the product of a particular person who manufactures, selects the name of, certifies or deals with the medicinal product, or offers it for supply;
“protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of any clinical research;
“regulated clinical trial” means a clinical trial that is —
(a)issued with a certificate under regulation 8 of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016); or
(b)authorised by the Authority, or notified to the Authority and the notification accepted by the Authority, under regulation 8 or 9 of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016);
“sponsor” means a person who takes responsibility for the initiation, management or financing of any clinical research;
“subject” means a human being, whether or not a patient, who participates in any clinical research —
(a)as a recipient of the clinical research material to which the research relates, or of some other treatment or procedure in that research; or
(b)as a control, without receiving any such clinical research material, or any such treatment or procedure.
Made on 13 July 2016.
Permanent Secretary,
Ministry of Health,
[HSA 401:04/05-000; HSA/LPPD/711:12/60-000; AG/LEGIS/SL/176/2015/3 Vol. 1]