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Therapeutic Goods Administration prepare to fast track coronavirus vaccines and treatment

The Therapeutic Goods Administration is gearing up to fast track the approval of any vaccines or treatments to beat the coronavirus and warns against dodgy medicines.

The Therapeutic Goods Administration is gearing up to fast track the approval of any vaccines or treatments to beat the coronavirus and warns against dodgy medicines. Picture: STR/AFP/CHINA OUT
The Therapeutic Goods Administration is gearing up to fast track the approval of any vaccines or treatments to beat the coronavirus and warns against dodgy medicines. Picture: STR/AFP/CHINA OUT

Australia’s medicines regulator says it is ready to fast track the approval of any vaccines or treatments to beat the coronavirus as it warns the public to avoid dodgy coronavirus products.

It is also advising against stockpiling more than two weeks supply of medicine because it could create artificial shortages which deny other people medicines they require.

The Therapeutic Goods Administration (TGA) said it was closely monitoring international manufacturing of medicines and liaising with Australian medicine sponsors, wholesalers and pharmacists on medicine supply but as yet has identified no shortages linked to COVID-19.

The Therapeutic Goods Administration says using hand rubs, wipes and disinfectants, in accordance with the directions on the label, can be part of good hygiene practice and was the primary defence against coronavirus. Picture: Charlie Riedel
The Therapeutic Goods Administration says using hand rubs, wipes and disinfectants, in accordance with the directions on the label, can be part of good hygiene practice and was the primary defence against coronavirus. Picture: Charlie Riedel

News Corp revealed last week the bulk of the raw ingredients for generic medications used by most Australians are now made in China where many pharmaceutical factories have been closed due to the coronavirus.

Companies promoting medicines, vitamins and disinfectants as being able to prevent coronavirus could be breaking the law and must have scientific evidence to back their claims, the Therapeutic Goods Administration warned on Wednesday.

“Any representation made in the advertising of therapeutic goods which refers to novel coronavirus (explicitly or by implication) is a ‘restricted representation’ and cannot be used without prior approval from the TGA,” the regulator said, adding members of the public could be putting themselves in danger if they inhale antiseptic products to prevent coronavirus.

The Therapeutic Goods Administration warned medicines and supplements promoted as protecting against novel coronavirus were unlikely to be effective in preventing an infection. Picture: Jeenah Moon/Getty
The Therapeutic Goods Administration warned medicines and supplements promoted as protecting against novel coronavirus were unlikely to be effective in preventing an infection. Picture: Jeenah Moon/Getty

“We have received reports of topical antiseptics and other products being promoted for inappropriate uses (such as inhalation) in order to prevent novel coronavirus infection.

“Using products in a way that differs from the directions or instructions on the label can be dangerous.”

Using hand rubs, wipes and disinfectants, in accordance with the directions on the label, can be part of good hygiene practice and was the primary defence against coronavirus the TGA said.

However it warned medicines and supplements promoted as protecting against novel coronavirus were unlikely to be effective in preventing an infection.

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“The TGA is also not aware of any medicines or supplements available without prescription that will prevent or assist with recovery from a novel coronavirus infection,” the regulator said, adding people who became unwell and who suspected they had coronavirus must seek medical attention.

In January 2020, the Therapeutic Goods (Medical Devices – Novel coronavirus) (Emergency) Exemption 2020 was made in order to fast track new medical devices to diagnose and test for COVID-19.

Doctors caring for coronavirus patients can use unapproved medicines if other treatments are ineffective under the TGA’s Special Access Scheme, the TGA said.

A man being tested for coronavirus in a Wuhan based hospital, called Red Cross Hospital. Picture: STR/AFP
A man being tested for coronavirus in a Wuhan based hospital, called Red Cross Hospital. Picture: STR/AFP

News Corp has previously reported doctors at the Gold Coast hospital are using an HIV drug Kaletra to treat patients with the coronavirus. It is also being used overseas in clinical trials on the virus.

At the end of next month two large scale trials of an experimental antiviral Remdesivir will report. The World Health Organisation says it is the most promising treatment so far.

The TGA said it would monitor the outcome of these and other trials and was poised to fast track access to any new treatments.

While potential coronavirus vaccines have entered clinical trials it could be 18 months before any of them are ready to use.

Originally published as Therapeutic Goods Administration prepare to fast track coronavirus vaccines and treatment

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Original URL: https://www.couriermail.com.au/lifestyle/health/therapeutic-goods-administration-prepare-to-fast-track-coronavirus-vaccines-and-treatment/news-story/b32d7656df8592ea788478220b8c223e