Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022
I, Tracey Duffy, as delegate of the Secretary of the Department of Health, make the following determination.
Dated 30 August 2022
Tracey Duffy
First Assistant Secretary
Medical Devices and Product Quality Division
Health Products Regulation Group
Department of Health
Contents
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
Therapeutic Goods (Overseas Regulators) Determination 2018
1 Name
This instrument is the Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information |
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | The day after this instrument is registered. | |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 41BIB(2) of the Therapeutic Goods Act 1989.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
Note: See section 4.
Therapeutic Goods (Overseas Regulators) Determination 2018
1 Section 5 (after paragraph (c))
Insert:
(ca) Health Sciences Authority of Singapore;
Overview
The Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022, enacted on 30 August 2022 by Tracey Duffy as a delegate of the Secretary of the Department of Health, amends the Therapeutic Goods (Overseas Regulators) Determination 2018. This determination was introduced to address the need for Australia to align its regulatory framework with that of Singapore in relation to the oversight of therapeutic goods. By amending the 2018 Determination, the legislation aims to facilitate mutual recognition arrangements and streamline the processes for the regulation of therapeutic goods between the two countries, thereby enhancing the efficiency and effectiveness of the regulatory frameworks in both jurisdictions. This amendment is made under subsection 41BIB(2) of the Therapeutic Goods Act 1989, with the policy objective of fostering stronger international regulatory cooperation in the health sector.
Scope and Application
The Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022 extends the application of the Therapeutic Goods (Overseas Regulators) Determination 2018 to include the Health Sciences Authority of Singapore as a recognised overseas regulator for therapeutic goods. This determination applies to any person or entity involved in the manufacture, supply, or importation of therapeutic goods in Australia, with the aim of facilitating mutual recognition and regulatory alignment between Australia and Singapore. The geographic reach of this determination is limited to interactions and transactions involving therapeutic goods that are subject to regulation under the Therapeutic Goods Act 1989, and it applies to any person or entity within the Commonwealth of Australia. There are no specific exclusions or thresholds stated in the determination, but its application may be further defined or restricted through subordinate instruments issued under the authority of the Therapeutic Goods Act 1989. This amendment streamlines regulatory processes and enhances the efficiency of the therapeutic goods market by recognising the regulatory framework of Singapore as equivalent to that of Australia.
Key Provisions
The Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022 amends the Therapeutic Goods (Overseas Regulators) Determination 2018. The determination, made by Tracey Duffy as a delegate of the Secretary of the Department of Health, includes provisions that commence on the day after the instrument is registered (Section 2). The instrument is authorised under subsection 41BIB(2) of the Therapeutic Goods Act 1989 (Section 3). The main change introduced by this amendment is the addition of the Health Sciences Authority of Singapore as an approved overseas regulator for therapeutic goods, as outlined in Schedule 1 (Schedule 1).
This amendment imposes obligations on the Health Sciences Authority of Singapore, including compliance with Australian standards and regulations regarding the approval and regulation of therapeutic goods. The authority must ensure that the therapeutic goods it regulates meet the same standards as those regulated by the Therapeutic Goods Administration (TGA) in Australia. This includes requirements for the assessment, registration, and monitoring of therapeutic goods to ensure their safety, quality, and efficacy (Schedule 1).
Failure to comply with the provisions of this determination could result in penalties under the Therapeutic Goods Act 1989. For example, non-compliance by the Health Sciences Authority of Singapore could lead to actions against the therapeutic goods it regulates, including recalls, refusal of entry into Australia, or other enforcement actions by the TGA. While specific penalties are not detailed in the determination, the Therapeutic Goods Act 1989 provides for various civil and criminal penalties, including fines and imprisonment, depending on the severity and nature of the breach (Section 3). The determination ensures that any therapeutic goods approved by the Health Sciences Authority of Singapore meet the stringent standards set by Australian regulations, thereby protecting public health and safety.