Gabrielle O’Sullivan PhD MPH1
1Executive Officer
Royal Prince Alfred Hospital Institutional Biosafety Committee
Royal Prince Alfred Hospital
Australia
Giulia Giunti PhD2
2Quality Manager
Malaghan Institute of Medical Research
Wellington
New Zealand
New Zealand Therapeutic Products Bill
New Zealand is consulting on a proposal to replace the current Medicines Act 1981 with the new Therapeutic Products Bill [1].
At present, the Medicines Act 1981 is the main legislation for enabling access to safe medicines and medical devices. Natural health products are regulated by the Dietary Supplements Regulations 1985 under the Food Act 2014. The bill would repeal most provisions of the Medicines Act, except those relating to pharmacy ownership, and revoke the regulations made under the Act. It would also revoke the Dietary Supplements Regulations.
Changes that the bill proposes include: requiring therapeutic products to receive a market authorisation before they could be imported into, exported from, or supplied in New Zealand; providing for the regulation of a range of controlled activities; establishing a Therapeutics Products Regulator [2].
The bill had its first reading in Parliament on 14 December 2022 and has been referred to the Health Select Committee who called for submissions from the public. It is open for submissions from the public until 15 February 2023 New Zealand time [2, 3].
TGA Good Manufacturing Practice (GMP) Forum 2023
The TGA GMP Forum will be held in Sydney on 21 March 2023 at the International Convention Centre in Darling Harbour. It will be an in-person only event. Early-bird registration is open until Sunday, 19 February [4].
Travellers bringing their injectable medicines containing material of human or animal origin into Australia
From 21 December 2022, travellers entering Australia no longer need approval from the TGA to bring their injectable medicines containing material of human or animal origin. This aims to remove the barriers for travellers entering Australia who require ongoing treatment with lifesaving medicines, such as enoxaparin – a low molecular weight heparin – used to treat and prevent blood clots. Travellers can bring up to 3-months’ supply of their medicine. Previously, travellers entering Australia with injectable treatments of human or animal origin (other than insulin) were required to contact an Australian GP prior to their travel. The GP would then need to apply to the TGA to get permission for the traveller to bring the treatment into Australia [5]. However, any medicine or medical device that contains a biological – material derived from living cells and tissues – must be declared at the border [6].
ANZ LRA Webinar
ANZ LRA Webinar on Requirements, Regulatory Strategies and Best Practices for Cell Therapy Clinical Trials in the APAC Region was held on December 1, 2022. The recording is available on ISCT resources. The webinar is available free to ISCT members. [7]
Access pathways for unapproved therapeutic goods
The TGA encourages health practitioners at all times to use therapeutic goods that have been entered on the Australian Register of Therapeutic Goods (ARTG), as these have been evaluated for quality, safety and effectiveness (or performance). However, where it may be necessary to use a therapeutic good that is not on the ARTG, there are a number of pathways available to access unapproved therapeutic goods, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme. The TGA has developed a tool to guide health practitioners down the appropriate access pathway. [8]
REFERENCES
[1] Read the Bill, https://www.legislation.govt.nz/bill/government/2022/0204/latest/096be8ed81cd49a1.pdf, accessed 20 January 2023
[2] Therapeutic Products Bill, https://www.parliament.nz/en/pb/sc/make-a-submission/document/53SCHE_SCF_BILL_130084/therapeutic-products-bill, published 15 December 2022, accessed 20 January 2023
[3] New Zealand Therapeutic Products Bill – About the Bill, https://www.parliament.nz/en/pb/bills-and-laws/bills-proposed-laws/document/BILL_130084/tab/hansard, accessed 20 January 2023
[4] GMP Forum 2023, https://www.tga.gov.au/resources/event/workshops/gmp-forum-2023, accessed 19 January 2023
[5] Travellers with injectable medicines containing ingredients derived from animal or human origin no longer require TGA approval to enter Australia, https://www.tga.gov.au/news/media-releases/travellers-injectable-medicines-containing-ingredients-derived-animal-or-human-origin-no-longer-require-tga-approval-enter-australia, published 21 December 2022, accessed 19 January 2023
[6] Coming to Australia with medicines and medical devices, https://www.tga.gov.au/entering-australia, last updated 28 September 2020, accessed 19 January 2023
[7] ISCT ANZ LRA Webinar on Requirements, Regulatory Strategies and Best Practices for Cell Therapy Clinical Trials in the APAC Region December 1, 2022, https://www.isctglobal.org/viewdocument/requirements-regulatory-strategies.
[8] Accessing unapproved therapeutic goods tool, https://www.tga.gov.au/accessing-unapproved-therapeutic-goods-tool, accessed 19 January 2023