Why the TGA does not recognize FDA approvals
Dear Therapeutic Goods Administration,
Why does the Australian TGA not approve medications that are approved by the American FDA.
Yours faithfully,
R Paul Sharman
Good morning
Thank you for your email of 1 October 2022 and apologies for the delay in
responding to you.
In Australia. therapeutic goods are regulated under the [1]Therapeutic
Goods Act 1989 (the Act).
Where possible, we make use of assessments from comparable overseas
regulators (COR) and international assessment bodies (including US FDA) in
the regulation of medicines and medical devices. The criteria used to
identify a comparable overseas regulator and the processes for using
overseas assessments differ depending on the type of therapeutic good.
It is important to note that TGA is still the decision-maker and the COR
must meet our defined criteria and processes in accordance with our
regulatory framework.
Kind regards
Melanie
TGA International
Therapeutic Goods Administration
T: 1800 020 653 | E: [2][email address]
PO Box 100, Woden ACT 2606
The Department of Health and Aged Care acknowledges First Nations peoples
as the Traditional Owners of Country throughout Australia, and their
continuing connection to land, sea and community. We pay our respects to
them and their cultures, and to all Elders both past and present.
Dear Mr Sharman,
Thank you for your email to the Therapeutic Goods Administration (TGA).
The role of the TGA is to ensure that all therapeutic goods available on
the Australian market are safe, of high quality and effective for their
intended use, consistent with the Therapeutic Goods Act 1989. Unless
exempt, all products presented as therapeutic goods must be included in
the Australian Register of Therapeutic Goods (ARTG) before being imported
into, supplied in or exported from Australia.
TGA achieves regulation through a two-tiered, risk-based system, whereby
medicines are classified as either ‘listed’ (low risk) or ‘registered’
(high risk) based on the ingredients they contain and the therapeutic
indications (claimed health benefits) they use.
For medicines to be lawfully supplied in Australia, a sponsor must submit
an application, supported by relevant data, so that the TGA can establish
the acceptable safety, quality and efficacy of the medicine. Information
on the specific registration process for prescription medicines, including
data requirements, can be found
at: [1]www.tga.gov.au/prescription-medicines-registration-process.
Once an application is accepted by the TGA, a formal evaluation is carried
out in multiple stages by technical experts. This process may include
seeking advice from an independent committee of external experts. The
decision to approve a new therapeutic good is made if the TGA is able to
establish that the benefits of the therapeutic good outweigh the risks for
the intended population, and is based on the quality of the data submitted
by the sponsor. This robust and longstanding system has been implemented
to assure consumers and health professionals that medicines are safe and
effective for their intended use.
I would like to clarify and reassure you that while the TGA does work
closely with international counterparts, including the US Food and Drug
Administration (FDA), the TGA always makes its own sovereign regulatory
decisions, which considers the use of the medicine in the local Australian
context.
Once the medicine is approved, it can be included in the Australian
Register of Therapeutic Goods (ARTG) and supplied in Australia by the
sponsor.
As noted earlier, The TGA has strong working relationships with a wide
range of international agencies and is part of a network of international
regulators that meet frequently to discuss the development of various
medicines, such as COVID-19 vaccines. Through these relationships we are
actively monitoring the development of medicines occurring both in
Australia and around the world.
Australia is working internationally to share research and information
supporting new medicines, particularly COVID-19 vaccines. Indeed our
ability to work collaboratively with like-minded countries will give
greater assurances that new medicines are safe, efficacious and
manufactured appropriately. Further information on [2]international
collaboration can be found on the [3]TGA website.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [4][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [5]www.tga.gov.au
[6][IMG][7][IMG][8][IMG]
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The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
Dear Mr Sharman,
Thank you for your email to the Therapeutic Goods Administration (TGA),
and apologies for the delay in responding.
The role of the TGA is to ensure that all therapeutic goods available on
the Australian market are safe, of high quality and effective for their
intended use, consistent with the Therapeutic Goods Act 1989. Unless
exempt, all products presented as therapeutic goods must be included in
the Australian Register of Therapeutic Goods (ARTG) before being imported
into, supplied in or exported from Australia.
TGA achieves regulation through a two-tiered, risk-based system, whereby
medicines are classified as either ‘listed’ (low risk) or ‘registered’
(high risk) based on the ingredients they contain and the therapeutic
indications (claimed health benefits) they use.
For medicines to be lawfully supplied in Australia, a sponsor must submit
an application, supported by relevant data, so that the TGA can establish
the acceptable safety, quality and efficacy of the medicine. Information
on the specific registration process for prescription medicines, including
data requirements, can be found at:
[1]www.tga.gov.au/prescription-medicines-registration-process.
Once an application is accepted by the TGA, a formal evaluation is carried
out in multiple stages by technical experts. This process may include
seeking advice from an independent committee of external experts. The
decision to approve a new therapeutic good is made if the TGA is able to
establish that the benefits of the therapeutic good outweigh the risks for
the intended population, and is based on the quality of the data submitted
by the sponsor. This robust and longstanding system has been implemented
to assure consumers and health professionals that medicines are safe and
effective for their intended use.
I would like to clarify and reassure you that while the TGA does work
closely with international counterparts, including the US Food and Drug
Administration (FDA), the TGA always makes its own sovereign regulatory
decisions, which considers the use of the medicine in the local Australian
context.
Once the medicine is approved, it can be included in the Australian
Register of Therapeutic Goods (ARTG) and supplied in Australia by the
sponsor.
As noted earlier, The TGA has strong working relationships with a wide
range of international agencies and is part of a network of international
regulators that meet frequently to discuss the development of various
medicines, such as COVID-19 vaccines. Through these relationships we are
actively monitoring the development of medicines occurring both in
Australia and around the world.
Australia is working internationally to share research and information
supporting new medicines, particularly COVID-19 vaccines. Indeed our
ability to work collaboratively with like-minded countries will give
greater assurances that new medicines are safe, efficacious and
manufactured appropriately. Further information on [2]international
collaboration can be found on the [3]TGA website.
Regards,
Joe Hlubucek
International Engagement Section
International Regulatory Branch
Medicines Regulation Division | Health Products Regulation Group
Australian Government, Department of Health and Aged Care
Location: Fairbairn
PO Box 100, Woden ACT 2601, Australia
The Department of Health and Aged Care acknowledges First Nations peoples
as the Traditional Owners of Country throughout Australia, and their
continuing connection to land, sea and community. We pay our respects to
them and their cultures, and to all Elders both past and present.
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