PART 1 | Citation and commencement |
| 1. These Regulations are the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 and come into operation on 1 March 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 the CTGT product as an active constituent; and | | (b) | achieves its intended action by pharmacological, immunological, physiological, metabolic or physical means; |
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“administer”, in relation to a substance or an article, means to give or apply it 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 substance in a CTGT product, means —| (a) | the name or a synonym of the active substance 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 substance; |
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| “Authority’s website” means the Authority’s website at http://www.hsa.gov.sg; |
| “autologous”, in relation to a CTGT product, means a CTGT product that contains cells or tissues that are obtained only from the patient to whom the CTGT product is to be administered; |
“Class 1 CTGT product” means a CTGT product that —| (a) | is the result of only minimal manipulation of human cell or tissue; | | (b) | is intended for homologous use; | | (c) | is not combined or used with —| (i) | a health product categorised as a therapeutic product in the First Schedule to the Act; or | | (ii) | a health product categorised as a medical device in the First Schedule to the Act; and |
| | (d) | is assigned by the Authority as a Class 1 CTGT product due to a lower health risk to a user of the product; |
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| “Class 2 CTGT product” means a CTGT product other than a Class 1 CTGT product; |
“container”, in relation to a CTGT product, means an article or a packaging immediately covering the CTGT product, including any bottle, ampoule, blister pack, sachet, dial dispenser pack, strip pack, syringe, tube, vessel, vial, wrapper or other similar article, but does not include —| (a) | an article for ingestion; or | | (b) | an outer package or other packaging in which the container is further enclosed; |
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| “CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act; |
“dispense”, in relation to a CTGT product, means to prepare and supply the CTGT product to a patient, where the preparation and supply is made by —| (a) | a qualified practitioner or a person acting under the supervision of a qualified practitioner; or | | (b) | a qualified pharmacist or a person acting under the supervision of a qualified pharmacist; |
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| “expiry date”, for a CTGT product, means the date after which, or the month and year after the end of which, the CTGT product should not be administered; |
“Good Distribution Practice Standard for Medical Devices” means any of the following as shown on the Authority’s website:| (a) | the Singapore Standard for Good Distribution Practice for Medical Devices — Requirements (SS 620); | | (b) | any other good distribution practice standard for medical devices that is approved by the Authority; |
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“Good Manufacturing Practice Standard” means any of the following as shown on the Authority’s website:| (a) | the Good Manufacturing Practice Standard for CTGT products issued by the Authority; | | (b) | any other good manufacturing practice standard that is approved by the Authority; |
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| “Good Tissue Practice” means the Authority’s tissue banking guidelines as shown on the Authority’s website; |
| “healthcare institution licence” means a licence issued under section 5(1) of the Private Hospitals and Medical Clinics Act (Cap. 248); |
| “healthcare institution licensee” means the holder of a healthcare institution licence for a private hospital or medical clinic; |
| “homologous use” means the use of a CTGT product to repair, reconstruct, replace or supplement the cells or tissue of an individual (called the recipient) if the CTGT product performs the same basic function or functions in the recipient as the original cells or tissue in the donor in the same anatomical or histological environment; |
| “international non‑proprietary name”, for an active substance of 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 substance; |
| “ISO 13485” means the 2016 edition of the publication ISO 13485, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes, published by the International Organization for Standardization; |
| “known importer” means a person who has given notice to the Authority under regulation 7 to import a CTGT product until the notice is refused, withdrawn or cancelled; |
| “known manufacturer” means a person who has given notice to the Authority under regulation 4 to manufacture a CTGT product until the notice is refused, withdrawn or cancelled; |
| “known wholesaler” means a person who has given notice to the Authority under regulation 10 to supply by wholesale a CTGT product until the notice is refused, withdrawn or cancelled; |
| “licensed healthcare institution” means a healthcare institution that is licensed under the Private Hospitals and Medical Clinics Act; |
| “licensed importer” means the holder of an importer’s licence; |
| “licensed manufacturer” means the holder of a manufacturer’s licence; |
| “licensed retail pharmacy” means the premises specified in a pharmacy licence; |
| “licensed wholesaler” means the holder of a wholesaler’s licence; |
| “licensee”, in relation to a CTGT product, means a licensed manufacturer, licensed importer or licensed wholesaler; |
| “medical clinic” means a medical clinic that is licensed under the Private Hospitals and Medical Clinics Act; |
“minimal manipulation” means processing a cell or tissue (but not a gene) by way of any process so that the biological characteristics or functions of the cell or the structural properties of the tissue (as the case may be) are not altered, such as by —| (a) | cutting or sizing; | | (b) | grinding; | | (c) | shaping; | | (d) | centrifugation; | | (e) | soaking in an antibiotic or antimicrobial solution; | | (f) | sterilization or irradiation; | | (g) | cell separation, concentration or purification; | | (h) | filtration; | | (i) | lyophilisation; | | (j) | freezing; | | (k) | cryopreservation; or | | (l) | vitrification; |
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| “non‑clinical purpose” means any purpose not involving any application of a CTGT product on, or administration of a CTGT product to, humans; |
| “private hospital” means a private hospital that is licensed under the Private Hospitals and Medical Clinics Act; |
| “proper handling and storage requirement”, in relation to an applicant for a licence connected with a CTGT product or a manufacturer or an importer of a CTGT product, means a requirement to provide and maintain, or ensure the provision and maintenance of, adequate and suitable staff, premises, equipment and facilities for the proper handling and storage of the CTGT product so as to prevent the deterioration of the CTGT product while it is in the ownership, possession or control of the applicant, manufacturer or importer; |
| “proprietary name” means a word or words used in connection with the sale or supply of a CTGT product for the purpose of indicating that the CTGT product is the product of a particular person who manufactures, selects the name of, certifies or deals with the CTGT product, or offers it for sale or supply; |
“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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“specified premises” means —| (a) | in the case of a licence — the premises specified in the licence; or | | (b) | in the case of a notice given to the Authority under regulation 4, 7 or 10 — the premises specified in the notice; |
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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; |
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| “supply by retail sale” means sale by retail and includes exposure or display as an invitation to treat; |
“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 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 patient; |
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“trade description” means any description, statement or indication which, directly or indirectly and by any means given, relates to any of the following matters in respect of a CTGT product:| (a) | the quantity, liquid volume or weight of the CTGT product; | | (b) | the method of manufacture, production or processing of the CTGT product; | | (c) | the characteristics, formulation or specifications of the CTGT product; | | (d) | the fitness for purpose (including expiry date), dosage strength or intended purpose of the CTGT product; | | (e) | any physical characteristics or presentation of the CTGT product not mentioned in paragraphs (a) to (d); | | (f) | the testing of the CTGT product by any person and the results of the test; | | (g) | the approval of the CTGT product by any person or its conformity with a product description approved by any person; | | (h) | the place or date of manufacture, production or processing of the CTGT product; | | (i) | the name of the person who manufactured, produced or processed the CTGT product. |
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(2) For the purposes of these Regulations, a prescription of a CTGT product is valid only if the prescription —| (a) | is in writing and signed by a qualified practitioner; and | | (b) | contains all 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 patient to whom the prescription relates; | | (iv) | the name and total amount of the prescribed CTGT product to be supplied to, and the dose to be taken by, the patient; | | (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 CTGT product may be supplied; | | (vi) | where the prescription is given by a registered dentist, a declaration by the registered dentist that the prescription is for dental treatment only. |
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| Clinical research CTGT products excluded |
| 3. These Regulations do not apply to or in relation to any CTGT product that is clinical research material as defined in regulation 2(1) of the Health Products (Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016). |
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