News Hub

Australia and New Zealand Legal and Regulatory Affairs 

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

VIRAL VECTOR PRODUCTION IN WESTERN SYDNEY
NSW has invested $25 million in a clinical grade viral vector manufacturing facility at the Westmead Health and Innovation District in Western Sydney. NSW Health Infrastructure is working with Investment NSW to expand capacity, infrastructure and attract investment partners to the facility. It is planned to expand capacity from 25 to 550 liters, thus helping to address the growing demand for viral vectors. [1, 2, 3]

NEW mRNA PLATFORM FOR NEW ZEALAND
New Zealand has procured the NanoAssembler Blaze machine which is designed to produce lipid nanoparticles to encapsulate mRNA for safe delivery to cells. It was funded by private donors to the Malaghan Institute and is being installed at South Pacific Sera, a biotech that is part of Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo. This will contribute to New Zealand’s capability and platforms for vaccine development to meet the current and future demands of infectious disease threats. [4]

In September last year, the COVID-19 Vaccination Corporation (CVC) of New Zealand joined forces with Australia’s BASE Nucleic Acids Biomanufacturing Facility to produce an mRNA COVID-19 vaccine. BASE is supported by Therapeutic Innovation Australia and the University of Queensland. [5, 6]

ADVANCED THERAPIES REGULATION
The TGA has improved accessibility to its information on advanced therapies regulation in Australia. It now provides (in one place) definitions, details about how they are regulated, how to make submissions, relevant EMA guidelines, clinical trial requirements and contact details for advanced therapies. [7]

ADVERTISING

Webinar: 2021 Therapeutic Goods Advertising Code

The TGA has produced a webinar to guide advertisers through the new Therapeutic Goods Advertising Code 2021. It highlights changes to the 2021 Code compared to the 2018 Code and explains compliance obligations for advertisers during the six-month transition period from 1 July 2022 when the 2018 Code will be repealed. [8] 

COVID-19 VACCINES, TREATMENTS, PREVENTIVE TREATMENTS AND RECOGNITION OF VACCINES NOT REGISTERED IN AUSTRALIA BUT USED INTERNATIONALLY

New provisionally approvals of vaccines

• Novavax (Biocelect Pty Ltd's) COVID-19 vaccine NUVAXOVID [9]
  This is the first protein COVID-19 vaccine to receive regulatory approval in Australia.
• Pfizer's COVID-19 vaccine (COMIRNATY) provisionally approved for use as a booster in individuals aged 16-17 years old [10]

New provisional approvals of treatments

• Two oral COVID-19 treatments, molnupiravir (LAGEVRIO) and nirmatrelvir + ritonavir (PAXLOVID) [11]

Recognition of additional COVID-19 vaccines not registered in Australia but used widely internationally

• Two dose course of the Gamaleya Institute vaccine (Sputnik V, Russian Federation) is now 'recognised' for the purpose of establishing a traveller's vaccination status. [12]
• Previously, as of 1 November 2021, the TGA recognised the following four vaccines for the purpose of travel to Australia: Coronavac (Sinovac), Covidshield (AstraZeneca - Serum Institute of India), BBIBP-CorV for people aged 18 - 60 years of age (Sinopharm China), and Covaxin (Bharat Biotech). [13]

CONFERENCE
The ISCT Australia and New Zealand Region (ANZ) and Biotherapeutics Association of Australasia (BAA) Joint Scientific Meeting was held on 24^th – 25^th February 2022. It was planned to be a virtual with in-person hub in Perth. It brought together foremost international and national speakers in cell and gene therapy. [14]

CONSULTATION ON ADOPTION OF INTERNATIONAL SCIENTIFIC GUIDELINES
The TGA has approximately 370 current adopted international scientific guidelines. It is consulting on whether or not certain additional international scientific guidelines should be adopted. These include:

• Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (EMA/CAT/80183/2014)
• Guideline on safety and efficacy follow-up - Risk management of advanced therapy medicinal products (EMEA/149995/2008)
• ICH Considerations. General principles to address virus and vector shedding (EMEA/CHMP/ICH/449035/2009)

In Australia, the technical data requirements for applications to register or vary the registration of medicines are closely aligned with requirements set out in relevant:

• European Union (EU) Guidelines
• Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Food and Drug Administration (FDA) Guidelines

While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified. [15]

STANDING GLOSSARY

ARTG: Australian Register of Therapeutic Goods. Therapeutic goods entered in the ARTG can

be lawfully supplied in Australia (https://www.tga.gov.au/australian-register-therapeutic-goods)

The TGA Black Triangle Scheme:  The Black Triangle Scheme provides a simple means for practitioners and patients to identify certain types of new prescription medicines, including those being used in new ways and to encourage the reporting of adverse events associated with their use. The Black Triangle does not denote that there are known safety problems, just that the TGA is encouraging adverse event reporting to help us build up the full picture of a medicine's safety profile. (https://www.tga.gov.au/black-triangle-scheme)

Provisional approval: Provisional approval of prescription medicines allows the TGA to approve some prescription medicines for a limited period of time while more research is conducted. The provisional approval pathway is used when a new medicine is a promising treatment for a serious or life-threatening condition but there is less research available on the medicine than the TGA would normally require for the approval of a prescription medicine. Provisional approval provides early access to promising new prescription medicines for serious and life-threatening conditions. However, it is important to be aware that knowledge of the risks and benefits of these medicines is less certain than other approved prescription medicines. Because data about provisionally approved medicines is still being collected, it is very important for both patients and health professionals to report all side effects. The TGA provides an online form for reporting side effects.

Provisional determination: The granting of a provisional determination means that the TGA has made a decision that the sponsor who applied for the provisional determination in relation to a specified treatment is now eligible to apply for provisional registration of the treatment in the Australian Register of Therapeutic Goods (ARTG) or to apply to vary an existing approval. Provisional determination is the first step in the process and does not mean that an application for variation has been made by the sponsor - or that any such variation will be provisionally approved by the TGA. However, usually it is anticipated that a sponsor will submit an application for provisional registration shortly after the provisional determination has been granted.

Serious Scarcity Substitution Instruments (SSSIs): The Serious Scarcity Substitution Instruments (SSSIs) allow community pharmacists 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#:~:text=Serious%20Scarcity%20Substitution%20Instruments%20(SSSIs)%20allow%20community%20pharmacists%20to%20substitute,within%20the%20SSSI%20are%20met)

REFERENCES

[1] Viral Vector Manufacturing Facility, NSW Government Westmead Redevelopment, https://www.westmeadproject.health.nsw.gov.au/precinct/viral-vector-manufacturing-        facility, accessed 2 February 2022

[2] NSW seeks partners to upscale bio-tech facility, https://www.hinfra.health.nsw.gov.au/news/latest/latest/nsw-seeks-partners-to-upscale-bio-tech-facility, published 31 January 2022, accessed 2 February 2022

[3] Australian-first ‘viral vector’ gene therapy facility coming to Westmead Health Precinct, https://thepulse.org.au/2022/01/31/australian-first-viral-vector-gene-therapy-facility-coming-to-westmead-health-precinct/, published 31 January 2022, accessed 2 February 2022        

[4] Nanoparticle tech paves way for home-grown vaccines and therapeutics, https://www.malaghan.org.nz/news-and-reports/news/nanoparticle-tech-paves-way-for-home-grown-vaccines-and-therapeutics/, published 27 January 2022, accessed 2 February 2022

[5] New Zealand vaccine producer closer to goal by integrating mRNA Covid-19 technology with Australian research partner, COVID-19 Vaccine Corporation Ltd (CVC),  https://www.cvc.nz/News/16_sep_2021.html, published 16 September 2021, accessed 2 February 2022

[6] New Zealand vaccine producer closer to goal by integrating mRNA Covid-19 technology with Australian, Therapeutic Innovation Australia (TIA), https://www.therapeuticinnovation.com.au/post/new-zealand-vaccine-producer-closer-to-goal-by-integrating-mrna-covid-19-technology-with-australian, updated 19 October 2021, accessed 2 February 2022

[7] Advanced therapies, https://www.tga.gov.au/advanced-therapies, published 10 January 2022, accessed 2 February 2022

[8] Webinar presentation: 2021 Therapeutic Goods Advertising Code, 20 January 2022, https://www.tga.gov.au/webinar-presentation-2021-therapeutic-goods-advertising-code-20-january-2022, published 28 January 2022, accessed 2 February 2022

[9] TGA provisionally approves Novavax (Biocelect Pty Ltd's) COVID-19 vaccine NUVAXOVID, https://www.tga.gov.au/media-release/tga-provisionally-approves-novavax-biocelect-pty-ltds-covid-19-vaccine-nuvaxovid, published 20 January 2022, accessed 2 February 2022

[10] Pfizer's COVID-19 vaccine (COMIRNATY) provisionally approved for use as a booster in individuals aged 16-17 years old, https://www.tga.gov.au/media-release/pfizers-covid-19-vaccine-comirnaty-provisionally-approved-use-booster-individuals-aged-16-17-years-old, published 28 January 2022, accessed 2 February 2022

[11] TGA provisionally approves two oral COVID-19 treatments, molnupiravir (LAGEVRIO) and nirmatrelvir + ritonavir (PAXLOVID), https://www.tga.gov.au/media-release/tga-provisionally-approves-two-oral-covid-19-treatments-molnupiravir-lagevrio-and-nirmatrelvir-ritonavir-paxlovid, published 20 January 2022, accessed 2 February 2022

[12] TGA recognises the Gamaleya Institute vaccine (Sputnik V, Russian Federation) for international travel to Australia, https://www.tga.gov.au/media-release/tga-recognises-gamaleya-institute-vaccine-sputnik-v-russian-federation-international-travel-australia, published 17 January 2022, accessed 2 February 2022

[13] International COVID-19 vaccines recognised by Australia, https://www.tga.gov.au/international-covid-19-vaccines-recognised-australia, published 26 November 2021, accessed 29 November 2021

[14] ISCT ANZ – BAA Joint Scientific Meeting, 24 – 25 February 2022, Virtual and with in-person hub in Perth, https://www.isctglobal.org/events/event-description?CalendarEventKey=69908c7b-2188-4df5-9891-5bfe8295a1ab&Home=%2fisct-community%2fregional-communities, (accessed 2 February 2022)

[15] TGA Consultation on Adoption of certain international scientific guidelines in Australia, opened 10 Jan 2022, closes 20 Feb 2022, https://consultations.tga.gov.au/tga/proposed-adoption-of-international-scientific-guid/ (accessed 2 February 2022)