Regulation 1
Citation and commencement
Amended byS 108/2021 wef 01/03/2021
These Regulations are the Health Products (Clinical Research Materials) Regulations 2016 and come into operation on 1 November 2016.
/akn/sg/act/sub_leg/2007/HPA-S332-2016
Health Products (Clinical Research Materials) Regulations 2016
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- Type
- Subsidiary Legislation
- Status
- In force
- Enacted
- 2007
- Sections
- 28
Quick answer
About this subsidiary legislation
Health Products (Clinical Research Materials) Regulations 2016 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HPA-S332-2016 2007, currently marked in force and first recorded in 2007.
Part 1
GENERAL
Regulation 2
Definitions
Amended byS 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 430/2023 wef 31/12/2021S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021S 452/2022 wef 01/07/2022S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 802/2023 wef 18/12/2023S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 430/2023 wef 26/06/2023
Subregulation 1
Amended byS 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 430/2023 wef 31/12/2021S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021S 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021S 452/2022 wef 01/07/2022S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 108/2021 wef 01/03/2021S 802/2023 wef 18/12/2023S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023S 430/2023 wef 26/06/2023
In these Regulations, unless the context otherwise requires —[Deleted by S 730/2021 wef 01/10/2021][Deleted by S 430/2023 wef 26/06/2023][Deleted by S 802/2023 wef 18/12/2023](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”.
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“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;
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“approved permanent premises”, “approved conveyance” and “permanent premises” have the meanings given by section 2(1) of the Healthcare Services Act 2020;
Amended byS 430/2023 wef 26/06/2023
Definition
“Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg;
Definition
“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;
Definition
“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;
Amended byS 430/2023 wef 26/06/2023
Definition
“clinical research” means any research involving human beings (whether or not a regulated clinical trial);
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;
Amended byS 108/2021 wef 01/03/2021
Definition
“CTGTP Regulations” means the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021);
Amended byS 108/2021 wef 01/03/2021
Definition
“healthcare service licensee” means a person who holds a licence under the Healthcare Services Act 2020 to provide a licensable healthcare service;
Amended byS 430/2023 wef 26/06/2023
Definition
“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;
Amended byS 430/2023 wef 31/12/2021
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“investigational CRM” means any clinical research material that is to be tested or used as a reference in any clinical research;
Definition
“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;
Definition
“licensable healthcare service” has the meaning given by section 3(1) of the Healthcare Services Act 2020;
Amended byS 430/2023 wef 26/06/2023
Definition
“licensed retail pharmacy” means the premises specified in a pharmacy licence;
Definition
“pharmacy licence” means a licence issued under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);
Definition
“pharmacy‑only medicine” means a therapeutic product registered under the classification of “pharmacy‑only medicine” in the Register of Health Products;
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of any clinical research;
Definition
“psychotropic substance” means a substance specified in the First Schedule to the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016);
Definition
“qualified pharmacist” means a person who —
(a)
is registered as a pharmacist under the Pharmacists Registration Act 2007;
(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);
Amended byS 430/2023 wef 31/12/2021
Definition
“qualified practitioner” means —
(a)
a registered medical practitioner under the Medical Registration Act 1997; or
(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;
Amended byS 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021
Definition
“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);
Definition
“relevant fee” means a fee specified in the Second Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022);
Amended byS 452/2022 wef 01/07/2022
Definition
“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);
Amended byS 430/2023 wef 26/06/2023
Definition
“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;
Amended byS 108/2021 wef 01/03/2021
Definition
“sponsor” means a person who takes responsibility for the initiation, management or financing of any clinical research;
Definition
“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;
Definition
“temporary premises” means any premises other than permanent premises;
Amended byS 430/2023 wef 26/06/2023
Definition
“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act;
Amended byS 108/2021 wef 01/03/2021
Definition
“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
(ii)
dispensed or supplied the CTGT product by a healthcare service licensee using a remote service kiosk or by delivery to the person;
Amended byS 802/2023 wef 18/12/2023S 108/2021 wef 01/03/2021S 430/2023 wef 26/06/2023
Definition
“trial site” means a place where activities relating to a clinical trial are conducted.
Amended byS 430/2023 wef 26/06/2023
Part 2
EXCEPTIONS FOR MANUFACTURE, IMPORT AND SUPPLY OF CLINICAL RESEARCH MATERIALS
Regulation 3
Exceptions from Act
Subregulation 1
Section 12(1) of the Act does not apply to the manufacture of any clinical research material.
Subregulation 2
Subject to regulations 4 and 5, section 13(1) of the Act does not apply to the import of any clinical research material.
Subregulation 3
Subject to regulations 6 and 7, section 14(1) of the Act does not apply to the supply by wholesale of any clinical research material.
Subregulation 4
Subject to regulation 7, section 15(1) of the Act does not apply to the supply of any clinical research material.
Regulation 4
Notification of import of clinical research material
Amended byS 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021
Subregulation 1
Regulation 3(2) applies to the import of any clinical research material only if the person who imports the material (called in these Regulations an importer) gives the Authority notice of the import before importing the material.
Subregulation 2
The notice must be given in the form and manner, and within the time, specified on the Authority’s website.
Subregulation 3
Amended byS 430/2023 wef 31/12/2021S 430/2023 wef 31/12/2021
A notice of the import mentioned in paragraph (1) is not required if —
(a)
before 1 November 2016 —
(i)
the clinical research material was a medicinal product under the Medicines Act 1975; and
(ii)
the import of the product was permitted by the licensing authority under that Act in connection with any clinical trial regulated under the Medicines (Clinical Trials) Regulations (Rg 3); and
(b)
the clinical research material is imported in accordance with the permission.
Regulation 5
Approval for import of consignments of clinical research materials containing psychotropic substances
Amended byS 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022S 430/2023 wef 31/12/2021
Subregulation 1
Amended byS 108/2021 wef 01/03/2021
Despite regulation 3(2), an importer must not import any clinical research material that is a therapeutic product and that contains any psychotropic substance, except under and in accordance with a prior approval of the Authority for each consignment of the material to be imported.
Subregulation 2
Amended byS 452/2022 wef 01/07/2022
An application for an approval under paragraph (1) must —
(a)
be made in the form and manner specified on the Authority’s website;
(b)
be accompanied by such particulars, information, documents and samples as the Authority may require; and
(c)
be accompanied by the relevant fee.
Subregulation 3
Upon receiving an application under this regulation, the Authority may approve the application or refuse to approve the application.
Subregulation 4
The Authority may subject its approval to such conditions as the Authority thinks necessary and may, from time to time, by notice in writing to the person granted the approval —
(a)
modify or remove any condition of the approval; or
(b)
impose any new condition on the approval.
Subregulation 5
The conditions referred to in paragraph (4) may include a condition limiting the quantity which may be imported in the consignment under the approval, and different limits may be imposed under different approvals.
Subregulation 6
The Authority may, at any time, suspend or revoke any approval.
Subregulation 7
To avoid doubt, this regulation applies in addition to regulation 4.
Subregulation 8
Amended byS 430/2023 wef 31/12/2021
In this regulation, “prior approval of the Authority” includes a permission given before 1 November 2016 by the licensing authority under the Medicines Act 1975, for the importer to import a consignment of the clinical research material on or after that date in accordance with the conditions of the permission (if any).
Regulation 6
Approval for export of consignments of certain clinical research materials
Amended byS 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022S 730/2021 wef 01/10/2021
Subregulation 1
Amended byS 108/2021 wef 01/03/2021
This regulation applies to any clinical research material that is a therapeutic product and that —
(a)
contains any psychotropic substance; or
(b)
is a codeine cough preparation.
Subregulation 2
Despite regulation 3(3), the person must not export the clinical research material except under and in accordance with a prior approval of the Authority for each consignment of the material to be exported.
Subregulation 3
Amended byS 452/2022 wef 01/07/2022
An application for an approval under paragraph (2) must —
(a)
be made in the form and manner specified on the Authority’s website;
(b)
be accompanied by such particulars, information, documents and samples as the Authority may require; and
(c)
be accompanied by the relevant fee, if the material contains any psychotropic substance.
Subregulation 4
Upon receiving an application under this regulation, the Authority may approve the application or refuse to approve the application.
Subregulation 5
The Authority may subject its approval to such conditions as the Authority thinks necessary and may, from time to time, by notice in writing to the person granted the approval —
(a)
modify or remove any condition of the approval; or
(b)
impose any new condition on the approval.
Subregulation 6
The Authority may, at any time, suspend or revoke any approval.
Subregulation 7
Amended byS 730/2021 wef 01/10/2021
In this regulation, “codeine cough preparation” means a therapeutic product that —
(a)
is in liquid or solid form;
(b)
contains codeine or its salts; and
(c)
is intended for the treatment of coughs.
Regulation 7
Notification of supply of clinical research material by manufacturer
Subregulation 1
Regulation 3(3) and (4) applies to a supply of clinical research material by a person who manufactures the material (called in these Regulations a manufacturer) only if the manufacturer gives the Authority notice of the supply before the manufacturer supplies the material.
Subregulation 2
The notice must be given in the form and manner, and within the time specified, on the Authority’s website.
Subregulation 3
This regulation does not apply if the manufacture of the clinical research material being supplied comprises solely of the packaging or labelling of the material.
Part 3
MANUFACTURE AND IMPORT OF CLINICAL RESEARCH MATERIALS
Regulation 8
Manufacture and import of clinical research materials
Subregulation 1
A manufacturer of any clinical research material, or an importer of such material, must ensure that the material is of the correct identity and conforms with the applicable standards of strength, quality and purity for the material.
Subregulation 2
Despite paragraph (1), where the manufacturer of the clinical research material only packages or labels the material, the manufacturer need only ensure that the material is of the correct identity.
Part 4
SUPPLIES OF CLINICAL RESEARCH MATERIALS
Regulation 9
Supply only as clinical research material
Amended byS 108/2021 wef 01/03/2021
Subregulation 1
A person who manufactures, imports or is supplied with any clinical research material under regulation 3(1), (2), (3) or (4) must only supply the material for the purpose of being used in any clinical research in accordance with the protocol for the research.
Subregulation 2
Despite paragraph (1), the person may supply the clinical research material for a purpose other than that specified in paragraph (1) if the Authority has allowed such supply.
Subregulation 3
Amended byS 108/2021 wef 01/03/2021
To avoid doubt, as from the time that the Authority has allowed the supply for a purpose other than that specified in paragraph (1) —
(a)
the clinical research material in question ceases to be clinical research material; and
(b)
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.
Regulation 10
Repealed / deleted
[Deleted by S 730/2021 wef 01/10/2021]
Regulation 11
Supply to subject of prescription‑only or pharmacy‑only medicine
Subregulation 1
This regulation applies to a supply of any clinical research material that is prescription‑only medicine or pharmacy‑only medicine to a subject in any clinical research that is not a regulated clinical trial.
Subregulation 2
A person must not make the supply unless —
(a)
the person is specified in the first column of Part 1 of the Second Schedule; and
(b)
the person makes the supply in the circumstances specified against the person in the second column of Part 1 of the Second Schedule.
Regulation 12
Supply to subject by administration of prescription‑only medicine
A person must not administer any clinical research material that is prescription‑only medicine to a subject in any clinical research unless —
(a)
the person is a qualified practitioner; or
(b)
the person administers the material in accordance with the instructions of a qualified practitioner.
Regulation 13
Supply of clinical research material properly labelled
Subregulation 1
For the purpose of section 18 of the Act, a person must not supply any clinical research material for the purpose of being used in any regulated clinical trial, unless it is labelled in accordance with the Second Schedule to the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016); except that paragraph 1(1)(d), (2)(a) to (d) and (g), (3)(a) to (d), (g) and (j) and (4)(a), (b), (e) and (h) of that Schedule does not apply if the supply is by wholesale.
Subregulation 2
For the purpose of section 18 of the Act, a person must not supply any other clinical research material unless it is labelled in accordance with the requirements set out in the Third Schedule.
Part 5
DUTIES RELATING TO CLINICAL RESEARCH MATERIALS
Regulation 14
Dealing with clinical research materials
Amended byS 108/2021 wef 01/03/2021
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 —
(a)
except in accordance with the protocol for the research; and
(b)
where the research requires the approval of an institutional review board, only after the approval has been obtained.
Subregulation 3
Despite paragraph (2) —
(a)
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
(b)
the sponsor must ensure that the material is put to the other use.
Subregulation 4
Amended byS 108/2021 wef 01/03/2021
To avoid doubt, as from the time that the Authority has allowed the other use under paragraph (3) —
(a)
the clinical research material in question ceases to be clinical research material; and
(b)
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).
Regulation 14A
Duty to maintain system of traceability for CTGT product
Amended byS 108/2021 wef 01/03/2021
Subregulation 1
Every manufacturer, importer, supplier or registrant of clinical research material that is a CTGT product must establish and maintain a system of traceability that complies with paragraph (2).
Subregulation 2
The system mentioned in paragraph (1) must at the minimum enable the traceability of the CTGT product and its starting and raw materials, including all substances that may come into contact with the cells or tissue it contains, during any of the following processes:
(a)
sourcing;
(b)
procurement;
(c)
processing;
(d)
testing;
(e)
packaging;
(f)
storage;
(g)
transport;
(h)
delivery to the clinical research site where the CTGT product is used, administered, supplied or dispensed, as the case may be;
(i)
any other final reconciliation, disposal or destruction of the CTGT product.
Subregulation 3
Every supplier must ensure that a system of traceability is in place and maintained at the clinical research site in order that the CTGT product administered or supplied may be linked to the patient who received it, and vice versa.
Subregulation 4
Amended byS 108/2021 wef 01/03/2021
Every manufacturer, importer or supplier mentioned in paragraphs (1) and (3) must keep all data obtained from the system of traceability for at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.
Regulation 15
Records of manufacture
Amended byS 108/2021 wef 01/03/2021
A manufacturer must keep the following records:
(a)
in the case of a manufacturer of clinical research material — records of the manufacture, assembly and testing of the material;
(b)
in the case of a manufacturer of clinical research material that is a CTGT product — records of traceability.
Regulation 16
Records of receipt and supply
Amended byS 108/2021 wef 01/03/2021
Subregulation 1
Amended byS 108/2021 wef 01/03/2021
A person who supplies any clinical research material (including a manufacturer or an importer of the material who supplies the material) must keep records relating to every receipt (where applicable) and every supply by the person of the material, in order to permit proper evaluation to be made of the accountability of the material.
Subregulation 2
The records referred to in paragraph (1) include all of the following:
(a)
the proprietary name or description of the clinical research material;
(b)
the identification number of the clinical research material (including the control number, lot number, batch number or serial number);
(c)
where applicable, details of each receipt of the clinical research material by the person (whether as a result of an import by, or a supply to, the person), namely —
(i)
the date on which the material was received;
(ii)
the quantity of the material received; and
(iii)
the name and address of the person from whom the material was received;
(d)
details of each supply of the clinical research material by the person, namely —
(i)
the date on which the material was supplied;
(ii)
the quantity of the material supplied; and
(iii)
the name and address of the person to whom the material was supplied.
Subregulation 3
In addition to any records required to be kept under this regulation, where the clinical research material is pharmacy‑only medicine that is supplied to a subject, the person making the supply must also keep records of all of the following:
(a)
the name, identity card or other identification document number, and contact details, of the subject;
(b)
the strength of the material supplied;
(c)
the dosage, and the frequency and purpose of the treatment for which the supply is made.
Subregulation 4
In addition to any records required to be kept under this regulation, where the clinical research material is supplied to a subject against a valid prescription given by a qualified practitioner, the person making the supply must also keep records of all of the following:
(a)
the name, identity card or other identification document number, and contact details, of the subject;
(b)
if the material is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, the name and the address of the qualified practitioner who signed the prescription.
Subregulation 5
The records referred to in paragraphs (3) and (4) must be made on the day of the supply to which the records relate or, if that is not reasonably practicable, the next day.
Regulation 17
Records of dealings with clinical research materials
Amended byS 108/2021 wef 01/03/2021
Subregulation 1
Amended byS 108/2021 wef 01/03/2021
A sponsor must keep records relating to all clinical research materials that are put to some other use, disposed of or exported, as the case may be, under regulation 14, in order to permit proper evaluation to be made of the accountability of the material.
Subregulation 2
The records referred to in paragraph (1) include all of the following:
(a)
the proprietary name or description of the clinical research material;
(b)
the identification number of the clinical research material (including the control number, lot number, batch number or serial number);
(c)
the date on which the clinical research material was put to some other use, disposed of or exported;
(d)
the quantity of the clinical research material put to some other use, disposed of or exported;
(e)
the name and address of the person responsible for the putting to some other use, disposal or export, of the clinical research material.
Regulation 18
Production of and time for keeping of records
Amended byS 108/2021 wef 01/03/2021S 108/2021 wef 01/03/2021
Subregulation 1
A person who is required to keep any record under this Division must —
(a)
keep the records for the applicable period specified in paragraph (2) or (3); and
(b)
produce the records for inspection when required by the Authority at any reasonable time during the applicable period.
Subregulation 2
Amended byS 108/2021 wef 01/03/2021
For records relating to any manufacture, assembly and testing of clinical research material, the applicable period is as follows:
(a)
in the case of registered and unregistered investigational clinical research material and unregistered auxiliary clinical research material — 5 years after the completion or discontinuation of the last clinical trial in which the batch of that material was used;
(b)
in the case of registered auxiliary clinical research material, the longer of the following periods:
(i)
one year after the expiry date of the material;
(ii)
5 years after the date of such manufacture, assembly and testing;
(c)
in the case of traceability records relating to clinical research material that is a CTGT product — 30 years after the expiry date of the product or any other shorter period that the Authority allows in a particular case.
Subregulation 3
Amended byS 108/2021 wef 01/03/2021
For records relating to the receipt and supply of, or the putting to some other use, disposal or export, of clinical research material, the applicable period is as follows:
(a)
where the clinical research is not a regulated trial and —
(i)
the clinical research material is not a CTGT product — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or
(ii)
the clinical research material is a CTGT product and —
(A)
the records do not relate to traceability — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or
(B)
the records relate to traceability — 30 years after the expiry of the CTGT product, or any other shorter period that the Authority allows in a particular case;
(b)
where the clinical research is a regulated clinical trial, the period for which records of the trial must be kept under regulation 23(2)(c) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016) or regulation 23(2)(c) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016), as the case may be.
Regulation 19
Notifications of unexpected serious adverse drug reactions
Amended byS 108/2021 wef 01/03/2021
Subregulation 1
Where, during any clinical research that is not a regulated clinical trial, any USADR occurs in a subject that results in death or is life‑threatening, then the sponsor must ensure that —
(a)
all relevant information about the USADR is —
(i)
recorded; and
(ii)
reported to the Authority as soon as possible and in any event not later than 7 days after the sponsor first becomes aware of the event; and
(b)
any additional relevant information about the USADR is —
(i)
recorded; and
(ii)
sent to the Authority within 8 days of the record referred to in sub‑paragraph (i).
Subregulation 2
Where, during any clinical research that is not a regulated clinical trial, any USADR that is not referred to in paragraph (1) occurs in a subject, the sponsor must ensure that all relevant information about the reaction is —
(a)
recorded; and
(b)
reported to the Authority as soon as possible and in any event not later than 15 days after the sponsor first becomes aware of the event.
Subregulation 3
Amended byS 108/2021 wef 01/03/2021
In this regulation —
Definition
“investigator’s brochure” means a document containing a summary of the clinical and non‑clinical data relating to the clinical research material relevant to the study of the material in subjects;
Amended byS 108/2021 wef 01/03/2021
Definition
“serious adverse drug reaction” has the same meaning as in regulation 2(1) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016);
Definition
“USADR” means an unexpected serious adverse drug reaction in a subject following the administration of any clinical research material to the subject, the nature and severity of which is not consistent with information about the material set out —
(a)
in the case of material that is a registered health product, in the product information leaflet or the investigator’s brochure relating to the material; and
(b)
in the case of material that is not a registered health product, in the investigator’s brochure relating to the material.
Regulation 19A
Duty to report defects
Amended byS 108/2021 wef 01/03/2021
For the purposes of section 42(1)(a) of the Act, every manufacturer, importer or supplier of any clinical research material must report any defect in the clinical research material to the Authority within the following period after the manufacturer, importer or supplier (as the case may be) first becomes aware of the defect:
(a)
if the defect represents a serious threat to persons or public health, within 48 hours;
(b)
in all other cases, within 15 days.
Regulation 20
Recall of clinical research material
Amended byS 108/2021 wef 01/03/2021
Subregulation 1
Amended byS 108/2021 wef 01/03/2021
For the purposes of section 44(1) of the Act, where any person intends to recall any clinical research material, the person must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of, and the reasons for, the intended recall.
Subregulation 2
The notice in paragraph (1) must be made in such form and manner as the Authority may require.
Subregulation 3
Where the Authority has been notified of the intended recall of any clinical research material under paragraph (1), the Authority may by written notice require the person to do either or both of the following:
(a)
investigate the matter occasioning the recall of the clinical research material and provide a report of the findings of the investigation;
(b)
take such other measures as the Authority thinks necessary.
Subregulation 4
A person to whom a notice in paragraph (3) is given must comply with the notice at the person’s own cost and within the time specified in the notice or, if no time is specified in the notice, within a reasonable time after the date of the notice.
Part 6
MISCELLANEOUS
Regulation 21
Certificate of manufacturing standard of clinical research materials
Amended byS 802/2023 wef 18/12/2023S 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022S 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022
Subregulation 1
Amended byS 802/2023 wef 18/12/2023S 108/2021 wef 01/03/2021
The Authority may, on the application of —
(a)
a manufacturer of any clinical research material; or
(b)
a manufacturer of a starting material used in the manufacture of clinical research material that is a CTGT product,and on being satisfied, after completing an assessment of conformity, that the manufacturer conforms to an applicable Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer subject to any terms and conditions as the Authority thinks fit.
Subregulation 2
Every GMP Certificate issued is valid for a period specified in the certificate, being not longer than 3 years starting on the date of commencement of the assessment mentioned in paragraph (1).
Subregulation 3
Amended byS 452/2022 wef 01/07/2022
An application for a GMP Certificate must —
(a)
be made in the form and manner specified on the Authority’s website; and
(b)
be accompanied by the relevant fee.
Subregulation 4
Amended byS 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022
In this regulation —
Definition
“GMP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Manufacturing Practice Standard;
Definition
“Good Manufacturing Practice Standard” means any of the following as shown on the Authority’s website:
(a)
for therapeutic products —
(i)
the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products; or
(ii)
any other good manufacturing practice standard approved by the Authority;
(b)
for CTGT products —
(i)
the Good Manufacturing Practice Standard for CTGT products issued by the Authority; or
(ii)
any other good manufacturing practice standard that is approved by the Authority.
Amended byS 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022
Regulation 22
Certificate of distribution standard of clinical research materials
Amended byS 108/2021 wef 01/03/2021S 452/2022 wef 01/07/2022S 452/2022 wef 01/07/2022
Subregulation 1
Amended byS 108/2021 wef 01/03/2021
The Authority may, on the application of a person who distributes a therapeutic product or CTGT product and on being satisfied, after completion of an assessment of conformity, that the person conforms to an applicable Good Distribution Practice Standard, issue a GDP Certificate to the person subject to any terms and conditions as the Authority thinks fit.
Subregulation 2
Every GDP Certificate issued is valid for a period specified in the certificate, being not longer than 3 years starting on the date of commencement of the assessment mentioned in paragraph (1).
Subregulation 3
Amended byS 452/2022 wef 01/07/2022
An application for a GDP Certificate must —
(a)
be made in the form and manner specified on the Authority’s website; and
(b)
be accompanied by the relevant fee.
Subregulation 4
Amended byS 452/2022 wef 01/07/2022
In this regulation —
Definition
“GDP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Distribution Practice Standard;
Definition
“Good Distribution Practice Standard” means the Authority’s Guidance Notes on Good Distribution Practice and any other good distribution practice standard approved by the Authority.
Amended byS 452/2022 wef 01/07/2022
Regulation 23
Enforcement requirements
Subregulation 1
An enforcement officer may conduct routine inspections of —
(a)
any premises that are being used for the manufacture, supply or storage of any clinical research material; and
(b)
any conveyances that are being used for the transport of any clinical research material.
Subregulation 2
An enforcement officer conducting a routine inspection under paragraph (1) may —
(a)
require any person having possession or control of any clinical research material that is found during the inspection to furnish, without charge, a sample of such material for the Authority’s examination; and the person must comply with the requirement; and
(b)
take or cause to be taken any photograph of —
(i)
the premises or conveyances referred to in paragraph (1); or
(ii)
any property or material found on the premises or in the conveyances.
Regulation 24
Offences
Amended byS 108/2021 wef 01/03/2021S 730/2021 wef 01/10/2021S 108/2021 wef 01/03/2021
Subregulation 1
Amended byS 108/2021 wef 01/03/2021S 730/2021 wef 01/10/2021
A person shall be guilty of an offence if the person —
(a)
contravenes regulation 5(1), 6(2), 8(1), 9(1), 11(2), 12, 14(2), (3)(b) or (5), 14A(1), (3) or (4), 15, 16(1), (3), (4) or (5), 17(1), 18(1), 19(1) or (2), 19A, 20(4) or 23(2)(a); or
(b)
for the purposes of making an application or giving any notice or report to the Authority under these Regulations, furnishes the Authority with any particulars, information or document which the person knows is false or misleading, or any sample which the person knows is altered or adulterated.
Subregulation 2
Amended byS 108/2021 wef 01/03/2021
A person who is guilty of an offence for contravening regulation 14A(1), (3) or (4), 15, 16(1), (3), (4) or (5), 17(1), 18(1)(a) or 19(1)(a)(i), (b)(i) or (2)(a) shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Subregulation 3
A person who is guilty of an offence for contravening any other provision in paragraph (1)(a), or guilty of an offence under paragraph (1)(b), shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
Schedule 2
SECOND SCHEDULERegulation 11(2)Part 1SUPPLY TO SUBJECT OF CERTAIN THERAPEUTIC PRODUCTS OR CTGT PRODUCTSFirst column Second columnPerson who may supply Circumstances of supply1.For prescription‑only medicine(a)A qualified practitioner, or a person acting in accordance with the instructions of a qualified practitioner The supply is to a subject under the care of the qualified practitioner(b)An in-store pharmaceutical officer providing pharmacy services at or from a licensed retail pharmacy Either —
(i)
the supply is in accordance with a valid prescription given by a qualified practitioner; or (ii)for therapeutic products only the supply is of prescription-only medicine specified in the list of prescription-only medicines exempted for limited sale and supply, and made under all of the following conditions: (A)the medicine is labelled to show a maximum daily dose not exceeding that specified in the list; (B)the medicine is supplied in a quantity that does not exceed the maximum supply specified in the list; (C)the medicine is supplied to a subject who is of or above any minimum age specified in the list; (D)the in-store pharmaceutical officer keeps a record of the supply of the medicine under regulation 16(4)2.For pharmacy‑only medicine(a)A qualified practitioner, or a person acting in accordance with the instructions of a qualified practitioner The supply is to a subject under the care of the qualified practitioner(b)An in-store pharmaceutical officer engaged or employed by the holder of a pharmacy licence for the licensed retail pharmacy The supply is made at or from the licensed retail pharmacy[S 108/2021 wef 01/03/2021]Part 2definitions
1. For the purposes of item 1(b)(ii) in Part 1, “list of prescription‑only medicine exempted for limited sale and supply” or “list” means the list, as published on the Authority’s website, of therapeutic products classified as prescription‑only medicines that may be supplied at or from a licensed retail pharmacy without the need for a valid prescription.
Schedule 3
THIRD SCHEDULERegulation 13(2)LABELLING REQUIREMENTS1.—
(1)
Clinical research materials supplied on or after 1 November 2017 must be labelled with information for all of the following purposes:
(a)
to ensure protection of the subject and product tracking;[S 108/2021 wef 01/03/2021](b)to enable identification of the material and the trial;
(c)
to facilitate proper use and storage of the material;
(d)
to ensure the reliability and robustness of data generated in the trial.(2) Without limiting the generality of sub‑paragraph (1), every unregistered investigational CRM, every registered investigational CRM which does not satisfy the requirements in sub‑paragraph (5), and every unregistered auxiliary CRM must be labelled with all of the following information:
(a)
the words “For clinical research use only” or similar wordings;
(b)
a clinical research reference allowing identification of the trial, site, investigator and sponsor;
(c)
the research subject identification number or treatment number and, where relevant, visit number;
(d)
the name, address and telephone number of the main contact for —
(i)
information on the clinical research material;
(ii)
information on the research; and
(iii)
emergency unblinding;
(e)
in the case of clinical research material that is a therapeutic product, the name of the substance used in the therapeutic product and its strength or potency, as well as, in the case of blinded trials, the name of the comparator or placebo;[S 108/2021 wef 01/03/2021](ea)in the case of clinical research material that is a CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product, as well as, in the case of blinded trials, the name of the comparator or placebo;[S 108/2021 wef 01/03/2021](f)the pharmaceutical form, route of administration and quantity of dosage units of the clinical research material;
(g)
the directions for use of the clinical research material (which may be a reference to a leaflet or other explanatory document intended for use by the subject or person administering the material);
(h)
the batch or code number identifying the contents and packaging operation of the clinical research material;
(i)
the period of use (which may be an expiry date or a retest date), in month and year format and in a manner that avoids any confusion as to which is the month and which is the year;
(j)
the storage conditions;[S 108/2021 wef 01/03/2021](k)in the case of clinical research material that is an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 108/2021 wef 01/03/2021](l)in the case of clinical research material that is a CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 108/2021 wef 01/03/2021](m)in the case of clinical research material that is a CTGT product, any warning that is necessary for the CTGT product;[S 108/2021 wef 01/03/2021](n)in the case of clinical research material that is a CTGT product, any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.[S 108/2021 wef 01/03/2021](3) Without limiting the generality of sub‑paragraph (1), every registered investigational CRM which satisfies the requirements of sub‑paragraph (5) must be labelled with all of the following information:
(a)
the words “For clinical research use only” or similar wordings;
(b)
a clinical research reference allowing identification of the trial, site, investigator and sponsor;
(c)
the name of the person to whom the clinical research material is to be administered or the research subject identification number;
(d)
where the clinical research material is supplied or dispensed —
(i)
at a licensed retail pharmacy or a trial site that is not an approved permanent premises, temporary premises or an approved conveyance of a healthcare service licensee — the name, address and any identification number or logo of the licensed retail pharmacy or trial site; [S 802/2023 wef 18/12/2023](ii)at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee;
(iii)
at any temporary premises or approved conveyance by a healthcare service licensee under a business name —
(A)
if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or
(B)
in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or
(iv)
by a healthcare service licensee using a remote service kiosk or by delivery under a business name —
(A)
if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or
(B)
in any other case — the business name, address and any identification number or logo of the healthcare service licensee;[S 430/2023 wef 26/06/2023](e)the name of the clinical research material, being the proprietary name or the appropriate non‑proprietary name of the active ingredient in the clinical research material;[S 108/2021 wef 01/03/2021](f)in the case of clinical research material that is a therapeutic product, where the appropriate non-proprietary name is included on the name of the label of the product, the appropriate quantitative particulars of any active ingredient of the product;[S 108/2021 wef 01/03/2021](fa)in the case of clinical research material that is a CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;[S 108/2021 wef 01/03/2021](g)the directions for use of the clinical research material;
(h)
an appropriate control number, such as a serial number, batch number or lot number;
(i)
the expiry date of the clinical research material;
(j)
the date that the clinical research material is dispensed;
(k)
where the clinical research material is registered, the registration number assigned to the product by the Authority;[S 108/2021 wef 01/03/2021](l)the conditions under which the clinical research material must be stored;[S 108/2021 wef 01/03/2021](m)in the case of clinical research material that is an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 108/2021 wef 01/03/2021](n)in the case of clinical research material that is a CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 108/2021 wef 01/03/2021](o)in the case of clinical research material that is a CTGT product, any warning that is necessary for the CTGT product;[S 108/2021 wef 01/03/2021](p)in the case of clinical research material that is a CTGT product, any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.[S 108/2021 wef 01/03/2021](4) Without limiting the generality of sub‑paragraph (1), every registered auxiliary CRM must be labelled with all of the following information:
(a)
the name of the person to whom the clinical research material is to be administered or the research subject identification number;
(b)
where the clinical research material is supplied or dispensed —
(i)
at a licensed retail pharmacy or a trial site that is not an approved permanent premises, temporary premises or an approved conveyance of a healthcare service licensee — the name, address and any identification number or logo of the licensed retail pharmacy or trial site; [S 802/2023 wef 18/12/2023](ii)at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee;
(iii)
at any temporary premises or approved conveyance by a healthcare service licensee of a healthcare service licensee under a business name —
(A)
if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or
(B)
in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or
(iv)
by a healthcare service licensee using a remote service kiosk or by delivery under a business name —
(A)
if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or
(B)
in any other case — the business name, address and any identification number or logo of the healthcare service licensee;[S 430/2023 wef 26/06/2023](c)the name of the clinical research material, being the proprietary name or the appropriate non‑proprietary name of the active ingredient in the clinical research material;[S 108/2021 wef 01/03/2021](d)in the case of clinical research material that is a therapeutic product, where the appropriate non-proprietary name is included on the name of the label of the product, the appropriate quantitative particulars of any active ingredient of the product;[S 108/2021 wef 01/03/2021](da)in the case of clinical research material that is a CTGT product, the name of the CTGT product and a description, expressed qualitatively and quantitatively, of any active substance in the CTGT product;[S 108/2021 wef 01/03/2021](e)the directions for use of the clinical research material;
(f)
an appropriate control number, such as a serial number, batch number or lot number;
(g)
the expiry date of the clinical research material;
(h)
the date that the clinical research material is dispensed;
(i)
where the clinical research material is registered, the registration number assigned to the product by the Authority;[S 108/2021 wef 01/03/2021](j)the conditions under which the clinical research material must be stored;[S 108/2021 wef 01/03/2021](k)in the case of clinical research material that is an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;[S 108/2021 wef 01/03/2021](l)in the case of clinical research material that is a CTGT product, the list of excipients, including preservative systems (if applicable), for the CTGT product;[S 108/2021 wef 01/03/2021](m)in the case of clinical research material that is a CTGT product, any warning that is necessary for the CTGT product;[S 108/2021 wef 01/03/2021](n)in the case of clinical research material that is a CTGT product, any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.[S 108/2021 wef 01/03/2021](5) The requirements for the purpose of sub‑paragraphs (2) and (3) in relation to any investigational CRM are all of the following:
(a)
the material is not used in the clinical trial in a blinded fashion;
(b)
the material is not repackaged for use in the trial;
(c)
the material is used in accordance with the terms of its registration (if registered) or in accordance with the notice submitted to the Authority under regulation 16 of the CTGTP Regulations.[S 108/2021 wef 01/03/2021](6) The information referred to in sub‑paragraphs (2), (3) and (4) must be in English, and must be clearly legible and unambiguous.(7) The address and telephone number referred to in sub‑paragraph (2)(d) need not appear on the label if the subjects are given a leaflet or card providing such information and instructed to keep the leaflet or card in their possession at all times.(8) The information referred to in sub‑paragraphs (2)(b), (c), (d) and (f) to (i), (3)(a), (b), (d), (g), (j) and (k) and (4)(b), (e), (h) and (i) need not appear on the label if they are available by any other means, so long as —
(a)
sub‑paragraph (1) is complied with; and
(b)
the reasons for the omission are set out in the protocol or such other document as the Authority may allow.[S 108/2021 wef 01/03/2021](9) Sub‑paragraphs (1)(d), (2)(a) to (d) and (g), (3)(a) to (d), (g) and (j) and (4)(a), (b), (e) and (h) do not apply where the supply is by wholesale.(10) In this paragraph —“autologous”, in relation to a CTGT product, means a CTGT product that contains cells or tissue that are obtained only from the individual to whom the CTGT product is to be administered;“registered auxiliary CRM” and “registered investigational CRM” include auxiliary clinical research material or investigational clinical research material (as the case may be) that is treated as a Class 1 CTGT product under the CTGTP Regulations and for which a notice under regulation 16 of the CTGTP Regulations has been submitted to the Authority;“unregistered auxiliary CRM” and “unregistered investigational CRM” include auxiliary clinical research material or investigational clinical research material (as the case may be) that is treated as a Class 1 CTGT product under the CTGTP Regulations and for which a notice under regulation 16 of the CTGTP Regulations has not been submitted to the Authority.[S 108/2021 wef 01/03/2021]2. [Deleted by S 108/2021 wef 01/03/2021 wef 01/03/2021]
Common questions
- What is Health Products (Clinical Research Materials) Regulations 2016?
- Health Products (Clinical Research Materials) Regulations 2016 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HPA-S332-2016 2007, currently marked in force and first recorded in 2007.
- Is Health Products (Clinical Research Materials) Regulations 2016 still in force?
- Yes — Health Products (Clinical Research Materials) Regulations 2016 is currently in force.
- When did Health Products (Clinical Research Materials) Regulations 2016 take effect?
- Health Products (Clinical Research Materials) Regulations 2016 was first recorded in 2007.
- How many regulations does Health Products (Clinical Research Materials) Regulations 2016 have?
- Health Products (Clinical Research Materials) Regulations 2016 contains 26 regulations.
- Where can I read the official version of Health Products (Clinical Research Materials) Regulations 2016?
- The official text of Health Products (Clinical Research Materials) Regulations 2016 is published at sso.agc.gov.sg.