PART 1 | Citation and commencement |
| 1. These Regulations are the Health Products (Clinical Research Materials) Regulations 2016 and come into operation on 1 November 2016. [S 108/2021 wef 01/03/2021] |
2.—(1) In these Regulations, unless the context otherwise requires —“active substance”, in relation to a CTGT product, means a substance that —| (a) | is usable in the manufacture of a CTGT product as an active constituent; and | | (b) | achieves its intended action by pharmacological, immunological, physiological, metabolic or physical means; [S 108/2021 wef 01/03/2021] |
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“administer”, in relation to any clinical research material, means to give or apply to a human being, whether —| (a) | orally; | | (b) | by injection or by introduction into the body in any other way; or | | (c) | by external application, whether by direct contact with the body or not; |
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“appropriate non‑proprietary name”, in relation to an active ingredient of a therapeutic product or an active substance in a CTGT product, means —| (a) | the name or a synonym of the active ingredient or the active substance (as the case may be) described in the relevant monograph appearing in the latest edition of any specified publication; or | | (b) | in any other case, its international non-proprietary name or the accepted scientific name or other name descriptive of the true nature of the active ingredient or the active substance, as the case may be; [S 108/2021 wef 01/03/2021] |
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| “approved permanent premises”, “approved conveyance” and “permanent premises” have the meanings given by section 2(1) of the Healthcare Services Act 2020; [S 430/2023 wef 26/06/2023] |
| “Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg; |
| “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; |
| “business name”, in relation to a healthcare service licensee, means the name under which the healthcare service licensee is authorised by a licence under the Healthcare Services Act 2020 to carry on the business of providing a licensable healthcare service; [S 430/2023 wef 26/06/2023] |
| “clinical research” means any research involving human beings (whether or not a regulated clinical trial); |
“clinical research material” means any of the following that is manufactured, 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:| (a) | a therapeutic product; | | (b) | a CTGT product that is treated as a Class 1 CTGT product under the CTGTP Regulations and for which no notice has been submitted under regulation 4, 7 or 10 (as the case may be) of the CTGTP Regulations; | | (c) | a CTGT product that is treated as a Class 2 CTGT product under the CTGTP Regulations; | | (d) | a placebo; [S 108/2021 wef 01/03/2021] |
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| [Deleted by S 730/2021 wef 01/10/2021] |
| “CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act; [S 108/2021 wef 01/03/2021] |
| “CTGTP Regulations” means the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021); [S 108/2021 wef 01/03/2021] |
| “healthcare service licensee” means a person who holds a licence under the Healthcare Services Act 2020 to provide a licensable healthcare service; [S 430/2023 wef 26/06/2023] |
“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 comes into operation, is appointed under that Act; [S 430/2023 wef 31/12/2021] |
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| “international non-proprietary name”, for an active ingredient of a therapeutic product or an active substance in a CTGT product, means a name which has been selected by the World Health Organization as a recommended international non-proprietary name for the active ingredient or the active substance, as the case may be; [S 108/2021 wef 01/03/2021] |
| “investigational CRM” means any clinical research material that is to be tested or used as a reference in any clinical research; |
“in-store pharmaceutical officer” means —| (a) | a qualified pharmacist engaged or employed to provide pharmacy services at or from a licensed retail pharmacy; or | | (b) | a person acting under the supervision of the qualified pharmacist mentioned in paragraph (a) when providing pharmacy services at or from the licensed retail pharmacy; |
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| [Deleted by S 430/2023 wef 26/06/2023] |
| “licensable healthcare service” has the meaning given by section 3(1) of the Healthcare Services Act 2020; [S 430/2023 wef 26/06/2023] |
| “licensed retail pharmacy” means the premises specified in a pharmacy licence; |
| [Deleted by S 802/2023 wef 18/12/2023] |
| “pharmacy licence” means a licence issued under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016); |
| “pharmacy‑only medicine” means a therapeutic product registered under the classification of “pharmacy‑only medicine” in the Register of Health Products; |
| “prescription‑only medicine” means a therapeutic product or a CTGT product registered under the classification of “prescription‑only medicine” in the Register of Health Products; [S 108/2021 wef 01/03/2021] |
| “proprietary name” means a word or words used in connection with the supply of a therapeutic product or CTGT 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 that product, or offers it for supply; [S 108/2021 wef 01/03/2021] |
| “protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of any clinical research; |
| “psychotropic substance” means a substance specified in the First Schedule to the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016); |
“qualified pharmacist” means a person who —| (a) | is registered as a pharmacist under the Pharmacists Registration Act 2007; [S 430/2023 wef 31/12/2021] | | (b) | holds a valid practising certificate granted under section 23 of that Act; and | | (c) | is in active practice as defined in regulation 2 of the Pharmacists Registration (Practising Certificates) Regulations 2008 (G.N. No. S 438/2008); |
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“qualified practitioner” means —| (a) | a registered medical practitioner under the Medical Registration Act 1997; or [S 430/2023 wef 31/12/2021] | | (b) | a registered dentist under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act; [S 430/2023 wef 31/12/2021] |
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“regulated clinical trial” means any clinical trial that is —| (a) | 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); or | | (b) | issued with a certificate under regulation 8 of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016); |
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| “relevant fee” means a fee specified in the Second Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022); [S 452/2022 wef 01/07/2022] |
| “remote service kiosk” has the meaning given by regulation 2(1) of the Healthcare Services (Outpatient Medical Service) Regulations 2023 (G.N. No. S 410/2023); [S 430/2023 wef 26/06/2023] |
“specified publication” means any of the following:| (a) | the British Pharmacopoeia; | | (b) | the European Pharmacopoeia; | | (c) | the United States Pharmacopoeia and the National Formulary; | | (d) | any other publication that is specified on the Authority’s website; [S 108/2021 wef 01/03/2021] |
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| “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; |
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| “temporary premises” means any premises other than permanent premises; [S 430/2023 wef 26/06/2023] |
| “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act; [S 108/2021 wef 01/03/2021] |
“traceability”, in relation to a CTGT product, means —| (a) | the ability to locate and identify the CTGT product and its starting and raw materials at any point in time during its manufacture, import, supply or administration, including the sourcing, procurement, processing, testing, packaging, storage, transport, delivery and disposal of the CTGT product; | | (b) | the ability to identify the donor and tissue bank, blood bank or manufacturing facility that receives, processes or stores any cells or tissue that the CTGT product contains; | | (c) | the ability to locate and identify all data relating to any raw material or other substance that comes into contact with any cells or tissue that the CTGT product contains; and | | (d) | the ability to identify the person who is —| (i) | administered, dispensed or supplied the CTGT product at a licensed retail pharmacy or any approved permanent premises, temporary premises or approved conveyance of a healthcare service licensee; or [S 802/2023 wef 18/12/2023] | | (ii) | dispensed or supplied the CTGT product by a healthcare service licensee using a remote service kiosk or by delivery to the person; [S 108/2021 wef 01/03/2021] [S 430/2023 wef 26/06/2023] |
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| “trial site” means a place where activities relating to a clinical trial are conducted. [S 430/2023 wef 26/06/2023] |
(2) For the purposes of these Regulations, a prescription is valid only if the prescription —| (a) | is written and signed by a qualified practitioner; and | | (b) | contains all of the following particulars:| (i) | the date of the prescription; | | (ii) | the name and address of the qualified practitioner giving the prescription; | | (iii) | the name, identity card or other identification document number, and contact details, of the subject to whom the prescription relates; | | (iv) | the name and total amount of the prescribed clinical research material to be supplied to, and the dose to be taken by, the subject; | | (v) | where the qualified practitioner giving the prescription intends for the prescription to be repeated, an indication of the number of times, and the time period between which, the prescribed clinical research material may be supplied; | | (vi) | where the prescription is given by a dentist, a declaration by the dentist that the prescription is “for dental treatment only”. |
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