Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 Summary of Changes

As reported in February 2018 Newsletter, The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. These are the most significant changes to the legislation affecting complementary medicines in Australia since the Therapeutic Goods Act was introduced in 1989. The Bill establishes a new ‘intermediate’ pathway for complementary medicines, sitting between Aust-Listed and Aust-Registered. As well as this new registration pathway, there are changes to the permitted indications (see following story); improved access to new ingredients (there has been a fivefold growth in TGA approved new ingredients in the last few years!); market exclusivity for new ingredients & better IP Protection; closer alignment with overseas regulators; reforms to advertising; and, axing of the Complaints Resolution Panel. Please feel free to contact RFA Regulatory Affiars for more detailed information.   Source: Legislation passed (Editor’s noteKey dates to note—8 March 2018 - Permitted indications introduced; market exclusivity for new ingredients introduced. 30 June 2019 - Indications change fee $1,000 waiver expires. 5 March 2021 - transition period to relist ALL products with permitted indications. 6 March 2021 - listed medicines not transitioned will be cancelled.)

TGA Details “Assessed Listed Medicines” Pathway

The Therapeutic Goods Administration has implemented a new ‘assessed listed medicines’ pathway for sponsors to enter their products in the Australia Register of Therapeutic Goods (ARTG). Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications. An interactive decision tree has been developed to assist sponsors in determining which pathway is most suitable for their product.   Source: Assessed listed medicines (See alsoPathways for Complementary Medicine Products. This tool will assist potential sponsors of complementary medicines to determine the most suitable pathway to enter their product in the ARTG. CM pathways tool)

Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018 Gets Tabled

The Permissible Ingredient Determination No. 1 of 2018 has been registered on the Federal Register of Legislation. The determination provides for a number of changes and additions of ingredients, their names, content limits and required warning statements. The TGA will be providing industry with a minimum 18 months transition period.   Sources: Permissible ingredient legislation; &, LM Guidance doc

Permitted Indications Reform for Listed Medicines

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit. Indications available for use for listed medicines are now contained in a 'list of permitted indications'. The new permitted indications requirements apply to all complementary medicines and sunscreens. However, medicines that are listed for ‘export only’ and medicine kits are not affected by this change. The four main changes in the new legislation are: There is no 'free-text field'; sponsors who apply to list a new medicine will be required to select the indications for their medicine from the list of permitted indications; there is a 3 year transition period for sponsors of existing listed medicines to re-list their products using permitted indications; and, sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. The permitted indications reform came into effect on 6th March 2018. Sources: Permitted indications reform & Legislation

Health Canada Issues Warning About Products Containing Yohimbe

Health Canada had extended a warning on dietary supplement products being sold in Canada with Natural Products Numbers and containing illegal ingredients such as yohimbine and sildenafil analogues.   Source: Hank Schulz, Nutraingredients-USA Yohimbe warning.  Editor’s note: In Australia, the TGA has ruled Yohimbe (an evergreen tree, the bark of which contains yohimbine) is a prescription only substance. Consumers are also advised that yohimbine is a substance included in the Customs (Prohibited Imports) Regulations 1956.

TGA Safety Advisories—

Lida (Plus) capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein.   Source: Lida-plus capsules

Slim Trim Gold capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein.   Source: Slim trim gold

Nutra Organics Green Tea Extract capsules: the capsules contain the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events.   Source: Green tea caps

Arthrem capsules: Arthrem capsules contain the herbal ingredient Artemisia annua extract as the only active ingredient. The New Zealand therapeutic goods regulator, MedSafe, has received 14 reports of liver toxicity associated with the use of Arthrem.   Source: Arthrem

Ja Dera Max+ capsules: The capsules contain the undeclared substance lignocaine, also known as lidocaine. Lignocaine is a prescription-only medicine and is widely used as an anaesthetic and antiarrhythmic drug.     Source: Ja Dera Max

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