Australia is set to switch bilastine to OTC status
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8 February 2021
Australia is set to switch the antihistamine bilastine from prescription to non-prescription status.
Industry News - Tag: TGA
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Australia is set to switch bilastine to OTC status
Australia to consider additions to Appendix H
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24 December 2020
Australia is set to consider applications to add several active ingredients to Appendix H of the Poisons Standard, allowing medicines containing the substances to be advertised directly to consumers.
Australia gives go-ahead for OTC CBD products
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16 December 2020
Australia’s Therapeutic Goods Administration (TGA) has now given the final go-ahead for certain low-dose cannabidiol (CBD) medicines to be sold without a prescription. However, the TGA has made a number of changes to its interim decision released in September 2020.
Australia’s TGA acts on sports supplements
28 September 2020
Australia’s Therapeutic Goods Administration (TGA) has declared that certain sports supplements are therapeutic goods rather than foods.
Mixed results for Australian switch applications
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11 September 2020
Australia has once again rejected an application to switch the erectile-dysfunction drug sildenafil from prescription to non-prescription status but is set to make another triptan available without a prescription.
Australia set to allow OTC CBD products
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11 September 2020
Australia’s Therapeutic Goods Administration (TGA) is set to allow low-dose cannabidiol (CBD) medicines to be sold without a prescription.
Regulatory in brief | Europe, global collaboration, US
28 April 2020
In response to the COVID-19 pandemic, the European Council has adopted the European Commission’s proposal to postpone by one year the date of application of the new Medical Devices Regulation, regulatory agencies around the world have stepped up global collaboration, and the US has taken action on h...
Australia restricts OTC sales due to COVID-19
20 March 2020
Australia’s Therapeutic Goods Administration (TGA) has announced sales restrictions on prescription and non-prescription medicines following surges in demand during the COVID-19 pandemic.
WHO comments on ibuprofen and COVID-19
20 March 2020
The World Health Organization (WHO) has responded to reports that taking ibuprofen could worsen symptoms of the COVID-19 coronavirus.
Regulatory in brief | FDA, TGA, MHRA
24 October 2019
The US Food and Drug Administration (FDA) has updated its approach to homeopathic products, Australia’s Therapeutic Goods Administration (TGA) is consulting on a proposal affecting supports supplements, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced a promotion...