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
Giulia Giunti PhD
Quality Manager, Malaghan Institute of Medical Research
Wellington, New Zealand
Domestic mRNA vaccine manufacturing facility in Australia
On 23 March 2022, Moderna announced the finalization of a strategic partnership with the Australian Federal Government to establish a state-of-the-art domestic mRNA vaccine manufacturing facility in Australia. This finalizes the agreement in principle with the Australian Federal Government announced in December 2021. Under the terms of the 10-year agreement, Moderna will develop and commission the facility in Melbourne, Victoria. Construction is expected to commence before the end of 2022, with a target date of the end of 2024 for the facility to become operational, subject to planning and regulatory approvals. [1, 2]
Sydney Biomedical Accelerator
The Sydney Biomedical Accelerator (SBA) is a co-funded partnership project between NSW Health, Sydney Local Health District and the University of Sydney. It will be a state-of-the-art biomedical research complex spanning the University campus and the District’s Royal Prince Alfred Hospital campus. Located within the Tech Central precinct, the SBA will be positioned to dynamically collaborate with industry and start-ups as part of a world-leading hospital, university, and tech innovation eco-system. 
South Australian BioMed City program
MTPConnect has been appointed to deliver the External Innovation and Translation Intermediary services for Adelaide BioMed City (ABMC) health and life sciences Innovation District. ABMC comprises leading-edge anchor institutes and companies that cluster and connect with entrepreneurs, start-ups, SMEs, business incubators and accelerators.
It offers a mixed-use infrastructure where researchers, clinicians and students work together with entrepreneurs and leading industry players. 
Expanded large molecule analysis facility at Agilex Biolabs
Agilex Biolabs has launched a new laboratory for the analysis of large molecule therapeutics, more than doubling the geographic area of its Adelaide campus. This will provide analyses supporting treatment modalities such as antibody-drug conjugates, cell therapies, gene therapies, vaccines created using genetic platforms and the measurement of critical safety and efficacy endpoints in human clinical trials. 
TGA APPROVALS RELATED TO COVID-19
Biocelect Pty Ltd for COVID-19 vaccine Nuvaxovid 
AstraZeneca's COVID-19 vaccine as a booster dose 
AstraZeneca's combination therapy (tixagevimab and cilgavimab, EVUSHELD) for pre-exposure prevention (prophylaxis) of COVID-19 [8-10]
TGA consultation on Priority Review pathway
The TGA has consulted on the proposed adoption of a Priority Review pathway for marketing approval. The Priority Review pathway will prioritise the evaluation of novel biologicals that meet the eligibility criteria and have a full dossier, to reduce the target timeframe for a decision regarding the inclusion of the biological in the ARTG. A legislated timeframe of 150 working days is proposed for Priority Review which is consistent with benchmarks set by EMA and US FDA for similar programs, and the Priority Review pathway for prescription medicines used by TGA. 
TGA discussion paper on the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia
The TGA has produced a discussion paper on the potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia. The paper was informed by targeted discussions in early 2021. There were 56 responses from stakeholders across the healthcare sector, industry sector, and consumers. The discussions explored the potential benefits and limitations of mandatory reporting for adverse events related to medical devices. Almost three quarters of respondents were in favour of introducing mandatory reporting of medical device-related adverse events by healthcare facilities in Australia. The TGA will work closely with the Australian Commission on Safety and Quality in Health Care (ACSQHC), state and territory health departments, and private and day hospitals to progress the project. 
TGA consultation on repurposing of medicines
Repurposing medicines is the process of identifying potential new therapeutic uses for older medicines through new research and evidence. The House of Representatives Standing Committee on Health, Aged Care and Sport has recommended that the Department of Health continue to develop options that establish a more flexible way forward for the repurposing of drugs in Australia. The TGA is consulting on options for encouraging and reducing barriers for sponsors to seek registration of new indications to medicines already registered in Australia. 
Office of the Gene Technology Regulator (OGTR) consultation on a draft new application form for licences to conduct human clinical trials of genetically modified organisms (GMO)
The OGTR is developing a new form for applying for a licence to conduct a human clinical trial of GMO. It aims to better capture the information required to assess applications, and reduce the need for requests for additional details during the evaluation process and for detailed descriptions of GMO transport, storage and disposal procedures that align with standard requirements. It has consulted stakeholders by email and requested comments by 14 April 2022.
Other cell and gene therapy relevant consultations
FDA - Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products - Draft Guidance for Industry (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products)
FDA - Gene Therapy Products Incorporating Human Genome Editing- Draft Guidance for Industry (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-gene-therapy-products-incorporating-human-genome-editing)
ICH Q2(R2) Validation of analytical procedures (https://www.ema.europa.eu/en/ich-q2r2-validation-analytical-procedures , https://www.ich.org/news/ich-revision-q2r2-draft-guideline-reaches-step-2-ich-process and https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf).
ICH Q14 on analytical procedure development (https://www.ema.europa.eu/en/ich-q14-analytical-procedure-development , https://www.ich.org/news/ich-q14-draft-guideline-reaches-step-2-ich-process and https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf).
The TGA has provided information in relation to shortages of tocilizumab (Actemra) medicines [14, 15] and YERVOY 
The TGA has published a half-yearly snapshot of its medical device application processing times. 
The OGTR will hold its 9th National Institutional Biosafety Committee (IBC) Forum in Canberra on 12th and 13th May 2022. This will bring together representatives from all IBCs around Australia. It is also the 20th anniversary since the legislated national gene technology regulatory scheme began.
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 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 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 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#:~:text=Serious%20Scarcity%20Substitution%20Instruments%20(SSSIs)%20allow%20community%20pharmacists%20to%20substitute,within%20the%20SSSI%20are%20met)
 CAMBRIDGE, MA / ACCESSWIRE, https://s29.q4cdn.com/745959723/files/doc_news/Moderna-Finalizes-Strategic-Partnership-with-Australian-Government-2022.pdf , published 23 March 2022, accessed 24 March 2022
 T Lowrey, Moderna will produce its mRNA vaccines in Australia from 2024, with final deal signed off, https://www.abc.net.au/news/2022-03-24/moderna-will-produce-mrna-vaccines-in-australia-from-2024/100934812, published 23 March 2022, accessed 24 March 2022
 Sydney Biomedical Accelerator, https://sydneybiomedicalaccelerator.org/, accessed 24 March 2022
 Adelaide BioMed City - Health Innovation and Translation District, https://adelaidebiomedcity.com/, accessed 24 March 2022
 BiotechDespatch, Large molecule facility doubles size of leading bioanalytical laboratory, https://biotechdispatch.com.au/news/large-molecule-facility-doubles-size-of-leading-bioanalytical-la, published 24 March 2022, accessed 28 March 2022
 TGA approves provisional determination for Biocelect Pty Ltd for COVID-19 vaccine, Nuvaxovid, https://www.tga.gov.au/media-release/tga-approves-provisional-determination-biocelect-pty-ltd-covid-19-vaccine-nuvaxovid, published 10 March 2022, accessed 24 March 2022
 TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose, https://www.tga.gov.au/media-release/tga-provisionally-approves-astrazenecas-covid-19-vaccine-booster-dose, published 9 February 2022, accessed 24 March 2022
 TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, EVUSHELD) - for pre-exposure prevention (prophylaxis) of COVID-19, https://www.tga.gov.au/media-release/tga-provisionally-approves-astrazenecas-combination-therapy-tixagevimab-and-cilgavimab-evusheld-pre-exposure-prevention-prophylaxis-covid-19, published 25 February 2022, accessed 24 March 2022
 Evusheld, Australian prescription medicine decision summary, https://www.tga.gov.au/apm-summary/evusheld, published 7 March 2022, accessed 24 March 2022
 AusPAR: Tixagevimab and cilgavimab, https://www.tga.gov.au/auspar/auspar-tixagevimab-and-cilgavimab, published 11 March 2022, accessed 24 March 2022
 TGA Consultation: Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process, Opening date: 28 February 2022, Closing date: 28 March 2022, https://www.tga.gov.au/consultation/consultation-priority-review-pathway-biologicals-feasibility-potential-eligibility-criteria-and-determination-process, published 28 February 2022, accessed 28 February 2022
 TGA Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia, https://www.tga.gov.au/consultation/discussion-paper-potential-mandatory-reporting-medical-device-adverse-events-healthcare-facilities-australia, submission of feedback on the Discussion Paper closed on 13 December 2021, published 23 February 2022, accessed 24 March 2022
 Consultation: Repurposing of medicines, https://www.tga.gov.au/consultation/consultation-repurposing-medicines, Opening date: 10 March 2022, Closing date: 1 April 2022, published 10 March 2022, accessed 24 March 2022
 Shortages of tocilizumab (Actemra) medicines, https://www.tga.gov.au/alert/shortages-tocilizumab-actemra-medicines, published 11 March 2022, accessed 24 March 2022
 Tocilizumab (Actemra) shortage: Supply improving, https://www.tga.gov.au/alert/tocilizumab-actemra-shortage-supply-improving, published 11 March 2022, accessed 24 March 2022
 Database of section 19A approvals to import and supply medicines to address medicine shortages, https://www.tga.gov.au/ws-s19a-index, published 16 March 2022, accessed 24 March 2022
 Medical device application processing times, https://www.tga.gov.au/medical-device-application-processing-times, published 12 April 2022, accessed 13 April 2022