TGA Regulation Timeline

This page plots the timeline of events that led up to the TGA’s reform allowing for a genetically modified synthetic gene sequence encapsulated by a synthetic lipid to be considered a “vaccine” and plugged into a relatively newly formed regulatory pathway. A regulator, who’s role is to protect it’s people, but is funded by the sponsor, allowed a gene technology product, referred to as COVID-19 mRNA vaccines, to enter the newly legislated provisional registration pathway, which in record time, worked its way to full registration which now by default is somehow considered a vaccine platform. How on earth did we get here, that is what I’m attempting to plot.

Since 2022 the TGA, just like the WHO and FDA, have updated their website and deleted many pages, which makes it difficult to locate information, so be aware many links below are web archived pages. You’d think public health were trying to make it difficult for the public to find vaccine information!

There is no legal definition for “vaccine”

• IMPORTANT: No where in Therapeutic Goods Act or Regulations is there a definition for what constitutes a “vaccine” product, as such there is no legal definition. Yet the regulations call for an Advisory Committee on Vaccines (ACV)!
  • According to the regulations “vaccines” fall under the category of “Biological Medicine“, but not the blood/tissue product type of Biological.
  • The regulations have a definition for “gene therapy” products, yet mRNA “vaccines” some how escaped that category, yet fit the definition perfectly.
  • It appears if a sponsor refers to their product as a “vaccine” then it is considered a vaccine by the regulator!
  • It appears if the mRNA code encodes for an antigen protein, that is all that is needed for it to be considered a “vaccine”, if it encodes a human derived protein it will likely be considered a “drug”. It’s all in the code (as far as I can work out! – Totally shocking!)

To fully understand the TGA we need to also look at the history of the Department of Health in Australia, of which the TGA falls under.

TGA: Definition of Gene Therapy

Documents and links below help provide a thread of understanding of the local and global regulatory web and “justification” for consolidation, which they call “harmonisation”. It all sounds good to streamline the regulation of the same product around the world, until you realise the decisions are distantly related to “health” but closely controlled or influenced by those who profit.

Listed in reverse chronological order

This timeline is a work in progress, content will be added as time permits

2024

January 17, 2024 – The European lobby Kangaroo Group, hosted a lunch in the European Parliament with Members with BioNTech and Moderna as key speakers, to discuss the forthcoming revision of “European Commission’s proposal for a reform of the EU General Pharmaceutical Legislation (GPL)”. EU- ARCHIVE, KG – ARCHIVE, PDF, CREDIT

• Their objective to effecttively change the definition of gene therapy, underwhich their COVID-19 mRNA vaccines are classified, and to create a “definition of Platform Technologies, as well as a clear demarcation between Gene Therapies Medicinal Products that alter human genomes, and those that do not (e.g. mRNA).”
• [If it is happening in the EU, it’s likely happening with all regulators]

2023

February 24, 2023 TGA – Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process – submissions – READ, Priority review – WEB, Priority Review of Biologicals – READ, Application Process – READ

• [It’s unclear when the Priority Review legislation was updated as the TGA no longer add dates to their web pages, like they’re trying to hide something, at the very least make it harder to track their changes.]
• Consultation opened March 28, 2022 – REA

2022

August 1, 2022 – Journal of Law and Medicine: A new priority pathway for biologicals in Australia: contextualising and evaluating the proposed reforms by Rudge et al – READ, READ

• Examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the “New Frontier” of reform envisioned in a report completed by the Commonwealth Government in 2021….identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

July 4, 2022 – TGA Advanced Therapies: Report on ‘Cell, Gene and Tissue Regulatory Framework in Australia – A stakeholder engagement report on Advanced Therapies prepared for the Therapeutic Goods Administration – READ, Report – PDF, ARCHIVE

• In November 2021 the Therapeutic Goods Administration (TGA) commissioned Medical Technologies and Pharmaceuticals Growth Centre (MTP Connect) to conduct a stakeholder review of the regulatory framework for gene, cell and tissue therapies in Australia.

May 23, 2022 – ARCS Annual Conference 2022: Regulation of cell and gene therapies in Australia – Presentation – PDF

• Biological Medicines (prescription medicines) – vaccines (that do not contain viable human cells)
• February to April 2022 – TGA initiated a public consultation – support the introduction of a new Priority Review pathway for biologicals
  • Consideration for priority – the biological is to be used for treatment, prevention [AKA VACCINE!] or diagnosis of a life threatening disease or seriously debilitating condition (as described by the TGA)

January 10, 2022 – TGA – New catagory appears called Advanced Therapies, under which gene therapies suddenly appears! – ARCHIVE, READ, Quitely added to the website with NO press release or statement – ARCHIVE, unable to find regulatory change around this time – READ

2021

April 21, 2021 – Monash Uni: Monash supports Australia’s first mRNA vaccine facility – ARCHIVE

• The Victorian government has announced it will put $50 million towards the first domestic production of mRNA COVID-19 vaccines, such as Pfizer and Moderna…
• Experts from Monash University’s Biomedicine Discovery Institute will also work on the project, including mRNA specialists from the fields of biotechnology, infectious disease, immunity and cancer.
• The proven scalability and comparative low-cost vaccine manufacturing potential of mRNA vaccines and nanomedicines secures them as the critical technology platform for vaccines and medicines of the future.
• Increasingly, mRNA nanomedicine can also be used in the treatment of cancer, rare diseases, cellular engineering and protein-replacement therapy, so this investment will help accelerate mRNA projects and develop new treatments to save lives.

2019

November 21, 2019 : Good Manufacturing Practice (GMP) for new and emerging technologies: Advanced Therapy Medicinal Products (ATMPs) – Presentation – ARCHIVE, PDF

August 12, 2019 – Dept Health: Australian Health Management Plan for Pandemic Influenza (AHMPPI) – READ, ARCHIVE, PDF

• AHMPPI, the national government health sector pandemic influenza plan, outlines the agreed arrangements between the Australian Government and State and Territory Governments for the management of an influenza pandemic. This agreement was ignored a few months later when another respriatory virus pandemic was declared in 2020!
• The previous version of this plan was 2008, which conincidentally a year later the 2009 H1N1 pandemic was declared. The Australian govt did successfully utilised the plan that year.

2018

August 2, 2018 -TGA: Priority review pathway: prescription medicines- Information on the priority review pathway for the registration of novel prescription medicines – READ

2017

June 26, 2017 – TGA: Priority review pathway for the registration of novel prescription medicines for Australian patients, providing “faster assessment of vital and life-saving prescription medicines” – ARCHIVE, ARCHIVE

• The very pathway all COVID-19 vaccine entered to gain regulatory handshake
• Sponsors lodge their application first for TGA Secretary to determine whether the medicine/vaccine is eligible for registration via the Priority review pathway, once approved it enters the provisional pathway.

March 2017 – TGA: Expert Panel Review of Medicines and Medical Devices Regulation 2016 – Streamlining Statutory TGA advisory committees – ARCHIVE

• Efficiencies will be achieved through reducing the number of statutory advisory committees that provide independent expert advice to the TGA. – i.e. Advisory Committee for Vaccines (ACV) funded by the sponsor “cost arrangement” – TIMELINE

2016

September 15, 2016 – TGA: Australian Government Response to the Review of Medicines and Medical Devices Regulation – The case for reform presented by the Expert Panel – ARCHIVE, Reforms proposed – ARCHIVE

• “The Expert Panel identified several significant trends in the regulation of medicines and medical devices internationally. In particular,…allowing earlier access to medicines … through the development of provisional approval pathways” There are “benefits of harmonising international regulatory frameworks”.
• “TGA has a strong reputation as a regulator both domestically and internationally, and benchmarks well against comparable overseas regulators. However, …there are opportunities for reform and improvement in the regulation of therapeutic goods.”
• “…allowing for greater flexibility in approval pathways …(including greater use of overseas assessment reports and provisional approvals in certain circumstances) would expedite access to market without compromising the safety, quality and efficacy or performance of medicines and medical devices.” [Bold claim!]
• “The Panel also identified areas of regulation where a more risk-based approach could be adopted to more appropriately align regulation with the risk posed by regulated products” [Do you sense they are suggesting vaccines here, which are believed to be, by default of their name, safe and effective” ?]

May 2016 – The Australian Government Response to the Review of Medicines and Medical Devices Regulation – PDF, ARCHIVE

• Recommendation 10 – Provisional: “Subject to the provision of clear advice to consumers and health practitioners that the medicine has been granted provisional approval and the implications of that for the consumer/health practitioner”
  • [Was it made clear th the pubic and health practitioners that the COVID-19 vaccines in Australia were “Provisional” when released in 2021?]

2015

November 2015 – Australian Goverment establishes Medical Technologies and Pharmaceuticals Growth Centre (MTP Connect) – as part of the $248 million Industry Growth Centres Initiative, an alleged independent, not-for-profit organisation – ARCHIVE , Gov- ARCHIVE, Factsheet – PDF

• MTP Connect Chair, Dr Bronwyn Evans – was from 2009-2012, the Chair of the Medical Technology Association of Australia (MTAA), a national peak industry body representing companies in the medical technology industry…for a healthier Australia..and “also play a vital role in providing healthcare professionals with essential education and training” – of non-pharmaceutical products. REF

July 31, 2015 – Review of Medicines and Medical Devices Regulation: Recommendations to the Minister for Health on the Regulatory Frameworks for Medicines, Medical Devices, Complementary Medicines and Advertising of Therapeutic Goods – Stage TWO Review report – PDF, PDF, ARCHIVE

• “The rapid pace of innovation and change in the health sector confers both benefits and risks. The Government’s deregulation agenda is based on the core principle that well-designed regulation has a role in achieving the greatest net benefit for the Australian community….positioning Australia to effectively respond to emerging opportunities for, and manage challenges to the health and safety of the public”

March 31, 2015 – Expert Panel Stage ONE Review report and discussion papers – PDF, ARCHIVE

2015 – TGA Acronyms & Glossary – Definitions – ARCHIVE, READ

• Active Ingredient
• Anticeptic
• Bacterial endotoxin limit 
• Bioburden
• Biological
• Biological Medicine (vaccine)
• Cochrane review
• Common Technical Document (CTD) format – An internationally agreed set of specifications for a submission dossier….
• Disease
• Drug – See medicine (Section 3(1) of TG Act
• Genetically Modified Organism (GMO)
• Homoeopathic preparation   
• Informed consent
  • “In relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment”
• Medicine
• (no definition for “Gene Therapy” but can be found in the TG Regulations)
• (no definition for vaccine, can’t be found anywhere!)
• Medical Device – READ
• New chemical entity (NCE) – could be anything!
• Placebo
  • “An inactive substance or treatment that supposedly has no treatment value. It is given to participants in clinical trials as a control against which to compare the effects of the test substance. In practice, placebos may also have positive or negative effects on trial participants.” 
• Control
  • “In clinical trials comparing two or more interventions, a control is a person in the comparison group that does not receive the medicine or treatment under evaluation. Instead that person receives a placebo, no intervention, usual care or another form of care. In case-control studies, a control is a person in the comparison group without the disease or outcome of interest.”
• Therapeutic goods     

2014

October 28, 2014 – Dept. Health: Expert Review of Medicines and Medical Devices Regulation announced – ARCHIVE, Web page ARCHVIES

• Media Release: Health Minister Peter Dutton and Assistant Minister for Health Fiona Nash announced they had appointed an Expert Panel Review of Medicines and Medical Device Regulation – PDF
  • “We need a modern regulatory framework to ensure Australians can access the latest treatments in a timely manner,” Dutton
• The scope of the Review is set out in the Terms of Reference, review report due March 31, 2015 – PDF
• The Review panel experts are Emeritus Professor Lloyd Sansom AO (chair), Professor John Horvath AO, Mr Will Delaat AM

June 5, 2014 – The Health Ministerial Advisory Council – ARCHIVE

• Health Ministerial Advisory Council (Health MAC) has been established to provide advice to the Health Ministers about opportunities to reduce regulatory and red tape burden within the Health portfolio. Health MAC falls within the Deregulation Branch, Best Practice Regulation and Deregulation Division of the Department of Health.
  • Chair: Hon Peter Dutton MP, Minister for Health and Minister for Sport
  • Deputy Chair: Senator the Hon Fiona Nash, Assistant Minister for Health

April 22, 2014 – Dept Health: Regulation and Red Tape Reduction – The deregulation agenda – ARCHIVE

• Deregulation Unit within the Department’s Best Practice Regulation and Deregulation Division has been established to promote regulatory performance across the Health portfolio

March 19, 2014 – Abbott government as part the 2014 Autumn Repeal Day: The Australian Government Guide to Regulation – Cutting Red Tape, for the Australian Public Service involved in policy making, Honourable Josh Frydenberg MP, Parliamentary Secretary to the Prime Minister – READ, PDF, WEB

• It is no mandatory that every government policy proposal designed to introduce or abolish regulation must now be accompanied by an Australian Government Regulation Impact Statement (RIS)
• Australian Government has a plan to cut $1 billion in red tape every year. Regulation is “Any rule endorsed by government where there is an expectation of compliance”.

2011

May 31, 2011 – TGA – Biologicals legislation commenced following a recommendation from Commonwealth, State and Territory health ministers to improve the regulation of human tissues and cell-based therapies. – REF Providing the regulatory framework for biologicals

• What is regulated as a biological – Human derived – ARCHIVE
• Different to blood and tissued – ARCHIVE
• Don’d confuse “biological” with “biological medicine”, the latter is where “vaccine” is placed.
• First introduced in May 2011, the regulatory framework for biologicals provides the legislative basis for the regulation of human tissue and cell-derived products as well as live animal cell, tissues or organs that are supplied, in or exported from, Australia (TGA, 2017, 2021b). For those therapeutic goods, regulated by the TGA, and which are produced by genetic manipulation (GM), the TGA is required to seek advice from Office of the Gene Technology Regulator (OGTR) (TGA, 2004) – PDF

2009

2009 (end) – The first Australian Public Assessment Report (AusPAR) was published – a Publication of a regulatory decisions – REF, updated 2014 – READ

• “AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application”
• “The TGA works with international counterparts in order to reduce the worldwide regulatory burden and increase the global uniformity of data requirements. Thus, wherever possible, the TGA’s requirements are the same as those of other major regulatory agencies.” [Thus FDA, EMA and UK medical agency important to take note of]

2008

2008 – Department of Health and Ageing: Australian Health Management Plan for Pandemic Influenza (AHMPPI) 2008 – READ, REF,

• This plan was used the following year in the 2009 pandemic which ended up being “mild” – READ

2007

November 2007 – Biosecurity and Emergency Response: The National Health Security Act 2007 and the National Health Security Agreement – Dept Health 2007-08 Annual Report – PDF

• To improve the identification and response capacities of health authorities to national and international public health events, such as an influenza pandemic.
• N5H1 vaccines added to National Medical Stockpile
• Implemented outcomes of Oct 2006 National Pandemic Influenza Exercise — Exercise Cumpston’ 06 – READ
• Commenced revision of the Australian Health Management Plan for Pandemic Influenza (2003) to ensure that the plan is based on the latest evidence. (See 2008)

2006

October 16-19, 2006 – Exercise Cumpston’ 06 : Australia holds Australia’s largest ever health exercise and was one of the first major exercises on pandemic influenza conducted in any country – REPORT, READ, TIMELINE

2005

2005 – “Australia had been in the pandemic “ALERT” phase since 2005 following the emergence of the avian influenza A(H5N1) virus infection in humans.” REF

2004

August 19-20, 2004 – The 9th National Public Health Association of Australia Inc (PHAA) Immunisation & 1st PHAA Asia-Pacific Vaccine Preventable Diseases Conference: ‘Immunisation at the crossroads: Challenges and Strategies‘ –READ, REF, PHA is an advocacy group – ARCHIVE

• PHAA Vaccines in Public Health Short Course before the conference!
• 1998 the 6th conference Immunisation Beyond 2000 – HERE

January 2004 – Dept Health & Ageing: Protecting Australia against Communicable Disease: Everybody’s Business – PDF (Referenced by Halton)

• “Influenza virus is a continuing global threat because it can spread easily and evolve rapidly to elude our prevention and treatment strategies.” [i.e. flu vaccines]

2003

October 2003 – The Australian Action Plan for Pandemic Influenza was endorsed by the National Public Health Partnership and the Australian Health Ministers’ Advisory Council – Dept Health Annual Report 2003-04 – by Secretary of Department of Health and Ageing, Jane Halton – ARCHIVE, REF

• The 2003-04 outbreak of avian influenza H5N1 (bird ’flu) in Asia “was the second time in as many years that an unknown and highly contagious disease had posed a major international threat, the previous one being SARS” (a coronavirus)
• So Australia compiles an influenza plan (not a respiratory virus pandemic plan) to provide direction for the Australian, State and Territory governments and emergency services in the event of an influenza pandemic.
• “Influenza pandemics result from a major change in the structure of the influenza virus and are expected to occur about every 30 years. Experts predict that future pandemics are likely, if not inevitable.”
  • [They got their wish 6 years later, following the May 2009 definition change for what constitutes a pandemic, except there was pushback in Europe
• “The expectation of 50 years ago that humanity would soon wipe out infectious disease, has been replaced with the knowledge that we will probably never win the ‘arms race’ against ever-changing microbes and viruses” writes Jane Halton [1953 Salk polio vaccine was released], now in makes sense why she headed the organisation that would save the world with 100-day vaccines for Disease X!
  • Jane Halton became head of CEPI when it launched in 2017, in time for 2020 pandemic!

2002

May 2002 – NCIRS: Vaccine preventable diseases and vaccination coverage in Australia 1999 to 2000 – PDF, SOURCE, CREDIT

2000

November 26-28, 2002 – WHO/IVR: Ethical considerations arising from vaccine trials conducted in paediatric populations with high disease burden in developing countries – PDF

• “Each year, millions of children in developing countries suffer from infectious diseases. Of these, more than 2.7 million children under five (WHO 2001 estimate) die from diseases that are potentially preventable by vaccines. In light of these unacceptable rates of morbidity and mortality, the development or improvement of vaccines to meet the needs of children in developing countries continues to be one of the highest priorities, with the attendant requirement for an increasing number of trials to evaluate new vaccines.”
  • [This is an important claim which is parroted by WHO yet supply without citation]
• A cautious approach is appropriate in the conduct of vaccine trials among children in any circumstances because of their particular vulnerability in view of their inability to give informed consent and their sometimes greater potential to adverse reaction to vaccines.”

July 14, 2000 – Australian Children’s Hospital at Westmead and Children’s Medical Research Institute joint initiative: Gene Therapy Research Unit – ARCHIVE, REF

1997

1997 – National Centre for Immunisation Research and Surveillance (NCIRS) of Vaccine Preventable Diseases was established by the National Centre for Disease Control, Commonwealth Department of Health and Aged Care as an initiative under the Seven Point Plan for the “Immunise Australia” program. – (lots of ref) ARCHIVE, Research – ARCHIVES, Vaccine trials – ARCHIVE

• NCIRS has provided editorial and scientific support for the production of the Australian Immunisation Handbook and provided support to the Australian Technical Advisory Group on Immunisation (ATAGI)
• NCIRS 2002 report: Vaccine preventable diseases and vaccination coverage in Australia, 1999 to 2000 – PDF
• NCIRS 2001 edition: Immunisation – Myths & Realities. Responding to arguments against immunisation – a guide for providers (first pub. October 1994) – PDF
  • Look at charts on pg 10 & 11, and compare the dates on the Y-axis to comparable graphs found, and the Y-axis units – HERE, this is how they “debunk”.

February 1997 – Australian Government Immunise Australia Program: Population Health Division: The Seven Point Plan – ARCHIVE

• The Seven Point Plan was approved by Cabinet and launched by the Minister for Health and Family Services, the Hon Dr Michael Wooldridge, in February 1997
  • Initiatives (incentives) for Parents.
  • A bigger role for General Practitioners.
  • Monitoring & Evaluation of Immunisation Targets.
  • Immunisation Days.
  • Measles Eradication.
  • Education and Research.
  • School Entry Requirements

1995

October 1, 1995 – Therapeutic Goods Regulations – Definitions antiseptic, fungicide, viricide etc added – PDF, READ

1989

1989 – The Therapeutic Goods Act 1989 came into effect in 1991 giving the Commonwealth more clearly defined regulatory authority. hen the Therapeutic Goods Regulations 1990 were set

• The Therapeutics Goods Administration (TGA) was created as a Division of the (then) Department of Community Services and Health – history – READ
• The legislation was to streamline Commonwealth and State legislation and to allow the Government to charge fees to industry to meet the costs of therapeutic goods regulation – REF

1983

1983 – A New Pandemic emerges HIV/AIDS- Much of the world’s optimism about the state of health was shattered by a new, mysterious pandemic, HIV/AIDS. In Australia, the virus was first identified in a patient in Sydney in 1983 – REF

1981

1981 – WHO: World Health Day with the ‘Health for all by the year 2000‘ – REF

1937

1937 – The Federal Health Council (1925) is expanded to become the National Health and Medical Research Council (NHMRC) with State and Federal representatives, now to include members of the medical establishment – REF

1937 – The Commonwealth Government passed a Therapeutic Substances Act in 1937, giving the Minister for
Health power to control the importation and exportation of substances which were declared in the Gazette
to be therapeutic substances. – (more history) – REF

1926

1926 – Australia hosted the first League of Nations’ international conference on health – REF

• The delegates discussed early warning systems for epidemics and quarantine issues, as well as various medical problems… then the Great Depression hit followed by World War II, after which the World Health Organisation is formed, under the umbrella of the United Nations

1925

1925 – Federal Health Council to promote Federal-State cooperation established following a Royal Commission Commonwealth health system – REF

1921

March 1921 – The Commonwealth Department of Health was established – ARCHIVE

• “The panicked response to the 1919 influenza pandemic was a catalyst for founding the Commonwealth Department of Health in March 1921 .
• Other factors included recommendations from the State Premiers, the British Medical Association of Australia (the forerunner of the Australian Medical Association) and a blunt appeal to the Prime Minister, Billy Hughes, by Dr Victor Heiser from the Rockefeller Foundation’s International Health Board. Heiser told Hughes that Australia would be considered backward until it acquired a national health department.
• Rockefeller Foundation provided the “Government the financial incentives of temporary expertise in industrial hygiene, public health engineering and administration, as well as training scholarships” – REF
• Billy Hughes would go on to become Minister for Health and Repatriation – REF

–

1919

1919 – “Spanish influenza” was brought to Australia by returning servicemen. “The epidemic killed 12,000 Australians. It caused widespread panic. Troops were quarantined before being reunited with their families. Public meeting places such as hotels and theatres were closed, and masks had to be worn on the streets. The authorities’
response to the crisis was chaotic, with police being stationed along State borders to try to prevent the disease from spreading. – REF, HISTORY

• The panicked response to the 1919 influenza pandemic was a catalyst for founding the Commonwealth Department of Health in March 1921 – REF

1919 – The first international flight to Australia by Ross and Keith Smith, pointed to the need for improved quarantine and health services – REF

1916

1916 – Australia work with the Rockefeller-funded International Health Board to extend its hookworm eradication campaign to Australia – REF

1916 – WWI prompted the establishment in 1916 of the government Commonwealth Serum Laboratories to provide a source of anti-toxins and other biological agents, should overseas, supplies become scarce… – REF

1909

1909 – The Federal Quarantine Service within the Department of Trade and Customs is established – REF

• Commonwealth quarantine officers became part of an informal network of health officials and doctors operating at all levels around the country. It’s members started the public health movement leading to the Department of Health
• In 1900, life expectancy for men was 52 and 55 for women – REF
• In 1984 the quarantine responsibilities of the Department of Health,which was once its very nucleus, were transferred to the Department of Primary Industry – REF

1901

January 1, 1901 – Birth of the Commonwealth of Australia – TIMELINE