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 —“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 therapeutic product which is related to any dose administered to that subject; |
| “adverse event” means any untoward medical occurrence in a subject to whom an investigational therapeutic product has been administered, including any occurrence which is not necessarily caused by or related to that product; |
“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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“appropriate non‑proprietary name”, in relation to an active ingredient of a therapeutic 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; |
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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; |
| “auxiliary therapeutic product” means a therapeutic product used for the needs of a clinical trial as described in the protocol, but not as an investigational therapeutic product; |
“clinical trial in an emergency situation” means a clinical trial to determine the safety or efficacy of the investigational therapeutic 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; |
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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 (Act 29 of 2015) comes into operation, is appointed under that Act; |
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“investigational therapeutic product” means —| (a) | a therapeutic product; or | | (b) | a placebo, |
| that is to be tested or used as a reference in a clinical trial; |
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| “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 therapeutic product relevant to the study of the product in subjects; |
| “licensed healthcare institution” means a healthcare institution that is licensed under the Private Hospitals and Medical Clinics Act (Cap. 248); |
| “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, 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; |
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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 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 therapeutic product, or offers it for supply; |
| “protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial; |
“qualified practitioner” means —| (a) | a registered medical practitioner under the Medical Registration Act (Cap. 174); or | | (b) | a registered dentist under the Dental Registration Act (Cap. 76) whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act; |
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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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| “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 therapeutic product to which the trial relates, or of some other treatment or procedure in that trial; or | | (b) | as a control, without receiving any such investigational therapeutic product, or any such treatment or procedure; |
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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 therapeutic product used in a clinical trial; |
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| “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act; |
| “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 therapeutic product in question, set out —| (a) | in the case of an investigational therapeutic product that is a registered health product, in the product information leaflet or the investigator’s brochure relating to the product; and | | (b) | in the case of an investigational therapeutic product that is not a registered health product, in the investigator’s brochure relating to the product; |
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| “window period” means the period, determined based on scientific evidence, within which an investigational therapeutic product must be administered to a subject for it to have the intended potential direct benefit to the subject. |
(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 (Cap. 177A); and | | (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 in relation to the giving or refusing of consent on behalf of the minor to being a subject; or | | (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 in relation to the giving or refusing of consent on behalf of the adult to be a subject; or | | (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 therapeutic products that are not observational trials. |
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