PART 1 | Citation and commencement |
| 1. These Regulations are the Health Products (Clinical Trials) Regulations 2016 and come into operation on 1 November 2016. |
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 the CTGT product as an active constituent; and | | (b) | achieves its intended action by pharmacological, immunological, physiological, metabolic or physical means; [S 107/2021 wef 01/03/2021] |
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“adult” means a person who —| (a) | is at least 21 years of age; or | | (b) | is below 21 years of age, and is or was married; |
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| “adverse drug reaction” means any untoward and unintended response in a subject to an investigational product which is related to any dose administered to that subject; [S 107/2021 wef 01/03/2021] |
| “adverse event” means any untoward medical occurrence in a subject to whom an investigational product has been administered, including any occurrence which is not necessarily caused by or related to that product; [S 107/2021 wef 01/03/2021] |
“amendment” means an amendment to —| (a) | any term of an application for authorisation, or a notification, to conduct a clinical trial; or | | (b) | any particulars or documents (including a protocol) accompanying that application or notification; |
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| “applicable CTGT product” means a CTGT product that is treated as a Class 2 CTGT product under the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021); [S 107/2021 wef 01/03/2021] |
“appropriate non-proprietary name”, in relation to an active ingredient of a therapeutic product or an active substance in an applicable 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 107/2021 wef 01/03/2021] |
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| “authorisation” means an authorisation for a clinical trial referred to in regulation 7(2)(a)(i); |
| “Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg; |
| [Deleted by S 107/2021 wef 01/03/2021] |
| “auxiliary product” means a therapeutic product or an applicable CTGT product used for the needs of a clinical trial as described in the protocol, but not as an investigational product; [S 107/2021 wef 01/03/2021] |
| “CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act; [S 107/2021 wef 01/03/2021] |
“clinical trial in an emergency situation” means a clinical trial to determine the safety or efficacy of the investigational product being tested in the trial on subjects where —| (a) | the subjects are facing a life‑threatening situation that necessitates intervention; | | (b) | the subjects are unable to consent to being subjects in the trial as a result of their medical condition; and | | (c) | it is not feasible to request consents from the legal representatives of the subjects within the window period; [S 107/2021 wef 01/03/2021] |
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“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 431/2023 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 an applicable 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 active substance, as the case may be; [S 107/2021 wef 01/03/2021] |
| [Deleted by S 107/2021 wef 01/03/2021] |
“investigational product” means —| (a) | a therapeutic product; | | (b) | an applicable CTGT product; or | | (c) | a placebo, |
| that is to be tested or used as a reference in a clinical trial; |
[S 107/2021 wef 01/03/2021] |
| “investigator” means an investigator of a clinical trial; |
| “investigator’s brochure” means a document containing a summary of the clinical and non‑clinical data relating to an investigational product relevant to the study of the product in subjects; [S 107/2021 wef 01/03/2021] |
“licensed healthcare institution” means —| (a) | any premises or conveyance specified in a licence granted under the Healthcare Services Act 2020 for the provision of any licensable healthcare service; or | | (b) | a healthcare institution that is licensed under the Private Hospitals and Medical Clinics Act 1980; [S 1077/2021 wef 03/01/2022] |
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| “licensed retail pharmacy” means the premises specified in a pharmacy licence issued under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016); |
| “minor” means a person who is below 21 years of age, and is not and was never married; |
| “notification” means a notification of a clinical trial referred to in regulation 7(2)(a)(ii); |
“observational trial” means a clinical trial of one or more registered therapeutic products or registered applicable CTGT products (as the case may be), where all of the following conditions are met in respect of each product:| (a) | the product is prescribed by a qualified practitioner to a patient in the usual manner in accordance with the terms of the product registration; | | (b) | the decision to prescribe the product to the patient is clearly separated from the decision to include the patient in the trial; | | (c) | the assignment of any patient involved in the trial to a particular therapeutic strategy in which the product is used is not decided in advance by a protocol but falls within the current practice of the qualified practitioner carrying out the trial; [S 107/2021 wef 01/03/2021] |
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| “principal investigator” means a principal investigator of a clinical trial referred to in regulation 5(1); |
| “principles of good clinical practice” means the principles specified in the First Schedule; |
| “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 the therapeutic product or CTGT product (as the case may be) is the product of a particular person who manufactures, selects the name of, certifies or deals with that therapeutic product or CTGT product, or offers it for supply; [S 107/2021 wef 01/03/2021] |
| “protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial; |
“qualified pharmacist” means a person who —| (a) | is registered as a pharmacist under the Pharmacists Registration Act 2007; [S 431/2023 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); [S 731/2021 wef 01/10/2021] |
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“qualified practitioner” means —| (a) | a registered medical practitioner under the Medical Registration Act 1997; or [S 431/2023 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 431/2023 wef 31/12/2021] |
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| “relevant institutional review board”, in relation to a clinical trial, means the institutional review board that approved the trial; |
“serious adverse drug reaction” means any adverse drug reaction which —| (a) | results in death; | | (b) | is life‑threatening; | | (c) | requires in‑patient hospitalisation or prolongation of existing hospitalisation; | | (d) | results in persistent or significant disability or incapacity; or | | (e) | consists of a congenital anomaly or birth defect; |
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“serious adverse event” means any adverse event that —| (a) | results in death; | | (b) | is life‑threatening; | | (c) | requires in‑patient hospitalisation or prolongation of existing hospitalisation; | | (d) | results in persistent or significant disability or incapacity; or | | (e) | consists of a congenital anomaly or birth defect; |
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“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 107/2021 wef 01/03/2021] |
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| “sponsor” means a person who takes responsibility for the initiation, management or financing of a clinical trial; |
“subject” means a human being, whether or not a patient, who participates in a clinical trial —| (a) | as a recipient of an investigational product to which the trial relates, or of some other treatment or procedure in that trial; or [S 107/2021 wef 01/03/2021] | | (b) | as a control, without receiving any such investigational product, or any such treatment or procedure; [S 107/2021 wef 01/03/2021] |
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“substantial amendment” means an amendment —| (a) | which changes a sponsor or principal investigator of a clinical trial; or | | (b) | which is likely to affect to a significant degree —| (i) | the safety, or physical or mental integrity, of any subject of a clinical trial; | | (ii) | the scientific value of a clinical trial; | | (iii) | the conduct or management of a clinical trial; or | | (iv) | the quality or safety of any investigational product used in a clinical trial; [S 107/2021 wef 01/03/2021] |
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| “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act; |
“traceability”, in relation to an applicable 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 receives the CTGT product at a licensed healthcare institution or a licensed retail pharmacy at which the CTGT product is administered, dispensed or supplied to a subject; [S 107/2021 wef 01/03/2021] |
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| “trial site” means a place where activities relating to a clinical trial are conducted; |
“unexpected serious adverse drug reaction” or “USADR” means a serious adverse drug reaction, the nature and severity of which is not consistent with the information about the investigational product in question, set out —| (a) | in the case of an investigational product that is a registered health product, in the product information leaflet or the investigator’s brochure relating to the product; and [S 107/2021 wef 01/03/2021] | | (b) | in the case of an investigational product that is not a registered health product, in the investigator’s brochure relating to the product; [S 107/2021 wef 01/03/2021] |
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| “window period” means the period, determined based on scientific evidence, within which an investigational product must be administered to a subject for it to have the intended potential direct benefit to the subject. [S 107/2021 wef 01/03/2021] |
(2) For the purposes of these Regulations —| (a) | a reference to a person who lacks capacity to consent to the person or another person being a subject, is a reference to a person who lacks capacity to so consent within the meaning of section 4 of the Mental Capacity Act 2008; and [S 431/2023 wef 31/12/2021] | | (b) | a reference to a person who has such capacity is a reference to a person who does not lack such capacity. |
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(3) A reference in these Regulations to a legal representative of a subject or a prospective subject, is a reference to a person having capacity who is —| (a) | where the subject or prospective subject is a minor —| (i) | a deputy appointed under the Mental Capacity Act 2008 in relation to the giving or refusing of consent on behalf of the minor to being a subject; or [S 431/2023 wef 31/12/2021] | | (ii) | if there is no deputy referred to in sub‑paragraph (i), an adult parent, or (if there is no adult parent to act as a legal representative of the minor) a guardian, of the minor; and |
| | (b) | where the subject or prospective subject is an adult —| (i) | the donee or deputy appointed pursuant to or under the Mental Capacity Act 2008 in relation to the giving or refusing of consent on behalf of the adult to be a subject; or [S 431/2023 wef 31/12/2021] | | (ii) | where there is no donee or deputy referred to in sub‑paragraph (i), subject to paragraph (4), any of the following persons in descending order of priority:| (A) | a spouse of the adult; | | (B) | an adult child of the adult; | | (C) | a parent or guardian of the adult; | | (D) | an adult sibling of the adult; | | (E) | any other adult named by the adult (when the adult did not lack capacity) as someone to consult on the issue of the adult being a subject. |
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(4) For the purpose of paragraph (3)(b)(ii), all of the following apply:| (a) | the order of priority applies in the absence of actual notice of any contrary indication given by the subject or prospective subject (when the subject or prospective subject did not lack capacity); | | (b) | a person referred to in that paragraph cannot be a legal representative of the subject or prospective subject if the person is also a donee or deputy and there is an express provision in the lasting power of attorney or appointment by the court that the donee or deputy is not authorised to give consent to the adult being a subject; | | (c) | a person referred to in paragraph (3)(b)(ii)(B), (C), (D) or (E) —| (i) | may be a legal representative only if all persons having a higher priority compared to that person are not available or cannot be a legal representative by reason of sub‑paragraph (a) or (b); and | | (ii) | cannot be a legal representative if any person having an equal or a higher priority compared to that person (other than a person who cannot be a legal representative by reason of sub‑paragraph (a) or (b)) has objected to the adult being a subject. |
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3. These Regulations apply to all clinical trials of the following products that are not observational trials:| (a) | therapeutic products; | | (b) | applicable CTGT products. [S 107/2021 wef 01/03/2021] |
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