Australia and New Zealand Legal and Regulatory Affairs
Watchdog Update
August 2022
By:
Gabrielle O’Sullivan PhD MPH
Executive Officer, Royal Prince Alfred Hospital Institutional
Biosafety Committee, Royal Prince Alfred Hospital
Australia
Giulia Giunti PhD
Quality Manager, Malaghan Institute of Medical Research
Wellington, New Zealand
TGA
TGA guidance on applying the Advertising Code rules
All advertising of therapeutic goods that are allowed to be advertised to the public must comply with the requirements in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the 2021 Code). The 2021 Code came into effect on 1 January 2022 and had a 6 month transition period which ended on 30 June 2022. From 1 July 2022 all advertising, including on social media, must comply with the 2021 Code rules. The TGA has produced guidance to help stakeholders consider how to comply with the Code. [1]
TGA response to the MTP Connect report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives'
As a consequence of the House of Representatives Standing Committee on Health, Aged Care and Sport ‘Inquiry into approval processes for new drugs and novel medical technologies in Australia’ which took place from October 2020 to July 2021, the TGA commissioned MTP Connect to conduct a stakeholder review of, and produce a report on, the regulatory framework for gene, cell and tissue therapies in Australia.
MTP Connect published its report on 21 November 2021. On 4 July 2022, the TGA responded to the report with a number of commitments, such as to undertake a review the Clinical Trials Approval (CTA) process, provide increased guidance on GMP requirements at various stages of cell and tissue therapy development, better align requirements and definitions with those of international regulators where possible, and improve communications. [2]
The TGA has incorporated (among other plans) into its Business Plan 2022-2023 a plan to reform clinical trials regulation (particularly of medical devices and cell and tissue products) to address safety concerns. [3]
TGA approval to change blood donation rules relating to vCJD deferral
The TGA has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'. The decision follows an application to the TGA from the Australian Red Cross Lifeblood to remove the deferral. The deferral was applicable to blood and plasma donors who spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996. The TGA conducted a scientific, epidemiological and clinical assessment of the risk model submitted by Lifeblood. It concluded that the modelled risk is reliable and by removing the deferral of vCJD the risk of transfusion transmission of vCJD would remain very low. The change will result in a potential modest increase in the number of blood and plasma donors in Australia. [4]
Information on the TGA Good Clinical Practice (GCP) Inspection Program
The TGA has published its presentation on 9 May 2022 providing an overview on the new Good Clinical Practice (GCP) Inspection Program guidance document on inspection of clinical trial sites for investigational biologicals and medicinal products. Under the Therapeutic Goods (Clinical Trials Inspections) Specification (no.2) 2020, the TGA can release the GCP inspection
reports and associated documents to the approving authority and the responsible ethics committee. [5]
TGA has ceased the Serious Scarcity Substitution Instrument (SSSI) for tocilizumab (Actemra) medicines as shortages have been resolved
Roche Products Pty Limited (Roche Australia) have announced that the shortages of intravenous (IV) and subcutaneous (SC) tocilizumab (Actemra) have been resolved and supplies have returned to normal pre-pandemic levels. As a result, the TGA’s Serious Scarcity Substitution Instrument (SSSI) which commenced on 29 April 2022 ceased to have effect on 30 June 2022, and the TGA shortage notification for the SC preparations of tocilizumab (Actemra) has been resolved. Tocilizumab is a humanized anti-human interleukin-6 receptor (anti-IL-6R) monoclonal antibody. In chimeric antigen receptor (CAR)-T-cell therapy, it is important for the management of cytokine release syndrome (CRS). [6, 7]
TGA vacancies on the statutory advisory committees
The TGA is seeking applications from professionals with relevant expertise in medicine, science or consumer perspectives and issues to sit on its statutory advisory committees. There are seven Advisory Committees covering Biologicals, Medicines, Vaccines, Complementary Medicines, Medical Devices, Chemicals Scheduling and Medicines Scheduling. Information about the Committees and how to apply is provided on the TGA website. Applications must be received by 11:30pm on Sunday 4 September 2022. There is also an information webinar for prospective applicants on Wednesday 24 August 2022 from 5:00pm - 6:00pm. [8, 9]
TGA business plan 2022-2023
The TGA has published its business plan for 2022-2023 [10]. The Plan sets out the TGA’s product regulation, stakeholder engagement, regulatory compliance and innovation agenda for 2022-2023 and lists the activities it will undertake to achieve these objectives.
Under the Plan the TGA focus includes:
- Continuing prioritised evaluations and post-market safety and performance monitoring of COVID-19 related products
- Reforming clinical trials regulation (particularly of medical devices and cell and tissue products) to address safety concerns.
- Introducing a priority review pathway for biologicals to enable faster patient access to cell and tissue therapies
- Working with National Regulatory Authorities within the Pacific and South-East Asia to strengthen regulatory systems
- Progressing process and policy reforms to facilitate repurposing of existing medicines to address unmet medical needs
- Continuing implementation of the Action Plan for Medical Devices.
- Communicate how TGA implements Real World Evidence (RWE) and Patient Reported outcomes (PROs) in its evaluation of medicines and medical devices
- Continuing its partnerships with international regulators, including through alliances such as Project Orbis, the Pharmaceutical Inspection Cooperation Scheme, the International Coalition of Medicines Regulatory Authorities, the International Medical Devices Regulators’ Forum, and the ACCESS Consortium
MEDSAFE
The 68th meeting of the Medicines Classification Committee held in Wellington on 26 April 2022, included the following [11]:
The committee agreed that amivantamab, zanubrutinib, faricimab and
ciltacabtagene autoleucel should be added to the New Zealand schedule as a prescription medicine.
In the context of the harmonisation of the New Zealand and Australian Schedules, the committee deliberated that belumosudil, estetrol monohydrate, finerenone, fostemsavir, inclisiran, pegcetacoplan, pegvaliase, sacituzumab govitecan, trastuzumab deruxtecan, vericiguat and zanubrutinib should be added to the New Zealand schedule as a prescription medicine.
Medicine Notification and Application forms
New Medicine Notification forms and New Prescription Medicine Application forms have been issued. [12]
STANDING GLOSSARY
Australian Register of Therapeutic Goods (ARTG): Therapeutic goods entered in the ARTG can be lawfully supplied in Australia (
https://www.tga.gov.au/australian-register-therapeutic-goods)
Good Clinical Practice (GCP): An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.
Good Manufacturing Practices (GMP): A set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
Serious Scarcity Substitution Instrument (SSSI): Serious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber. SSSIs are made for a defined period and may be revoked sooner.
https://www.tga.gov.au/serious-scarcity-substitution-instruments-sssis
REFERENCES
[1] Guidance on applying the Advertising Code rules,
https://www.tga.gov.au/guidance-applying-advertising-code-rules, published 1 July 2022, accessed 8 August 2022
[2] Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response,
https://www.tga.gov.au/report-cell-gene-and-tissue-regulatory-framework-australia-stakeholder-perspectives-tga-response, published 4 July 2022, accessed 8 August 2022
[3] TGA business plan 2022-23,
https://www.tga.gov.au/sites/default/files/tga-business-plan-2022-23.pdf, published 1 August 2022, accessed 8 August 2022
[4] TGA approval to change blood donation rules relating to vCJD deferral,
https://www.tga.gov.au/tga-approval-change-blood-donation-rules-relating-vcjd-deferral, published 25 July 2022, accessed 8 August 2022
[5] Webinar presentation: Information on the TGA Good Clinical Practice (GCP) Inspection Program, 9 May 2022,
https://www.tga.gov.au/webinar-presentation-information-tga-good-clinical-practice-gcp-inspection-program-9-may-2022, published 5 August 2022, accessed 8 August 2022
[6] Shortage of tocilizumab (Actemra) medicines: Resolved,
https://www.tga.gov.au/alert/shortage-tocilizumab-actemra-medicines-resolved, published 15 July 2022, accessed 8 August 2022
[7] Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2022 (Date ceased to have effect: 30 Jun 2022),
https://www.legislation.gov.au/Series/F2022L00121, accessed 9 August 2022
[8] Vacancies on the statutory advisory committees,
https://www.tga.gov.au/vacancies-statutory-advisory-committees, published 5 August 2022, accessed 8 August 2022
[9] TGA advisory committees: Information for prospective applicants,
https://www.tga.gov.au/tga-advisory-committees-information-prospective-applicants, published 5 August 2022, accessed 8 August 2022
[10] TGA business plan 2022-23,
https://www.tga.gov.au/resource/tga-business-plan-2022-23, published 1 August 2022, accessed 8 August 2022.
[11]
https://www.medsafe.govt.nz/profs/class/Minutes/2021-2025/mccMin26Apr2022.htm [12]
https://www.medsafe.govt.nz/regulatory/forms.asp#Regulatory#RegulatoryWatchdog#29.7