Safety Review of Coumarin in Topical Listed Medicines and Sunscreens

Coumarin is a naturally occurring chemical found in several food products such as cinnamon. Coumarin is currently permitted for use in listed medicine as an active homoeopathic ingredient (with a maximum concentration of 0.001%) and as an excipient in topical medicines for dermal application. The safety review has established that the appropriate tolerable daily limit for coumarin exposure from all sources (including diet, cosmetic products and sunscreens) is 0.1 mg/kg bodyweight. In the absence of a reliable estimation of Australian intake of coumarin from dietary and cosmetic sources, the requirements for listed medicines will specify that topical products may not exceed a concentration of 0.001% coumarin. Sponsors of existing listed medicines and sunscreens will have until 2 March 2021 to bring their products into compliance. This transition time will align with the March 2020 low-negligible risk changes to the Permissible Ingredients Determination.    Source: Coumarin safety review

Changes to the Label Warning Statement Requirements for Menthol and Methyl Salicylate

The Therapeutic Goods Administration (TGA) will be amending the requirements for menthol and methyl salicylate, to be less restrictive, in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). The amendments will mean that some of the existing label warning statements will not be required when these ingredients are present at very low amounts such as when included in topical proprietary ingredient (PI) formulations.    Sources: Menthol & salicylate changes  and LM's ingredients update

High-Moderate Risk Changes to Permissible Ingredient - Andrographis Paniculata

Andrographis paniculata (also known as ‘green chireta’) is a herb that is currently permitted for use in listed medicines as an active or homeopathic ingredient. Andrographis paniculata is typically used in relation to immune support and immune stimulating effects, such managing colds. The TGA published a safety review in 2015 that suggested an association between Andrographis paniculata and anaphylactic/allergic reactions and also published a safety alert. Since the review in 2015, the TGA has continued to receive adverse event reports concerning anaphylactic/allergic reactions associated with medicines that containing this herb. This further supports a causal association between this ingredient and anaphylactic/allergic reactions. Given the nature of the risk to some consumers, all listed medicines containing Andrographis paniculata, released for supply from 2 May 2020, will need to show the following label warning statement: 'Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention' (or words to that effect).    Source: Andrographis warning statement

Outcomes: Changes to Permissible ingredients that are Classified as Low-Negligible Risk

On 30 August 2019, the TGA sought comments on proposed changes to the permissible ingredients:  Boron, Withania somnifera, Vitex agnus-castus (VAC), Hydroxyisohexyl-3-cyclohexene carboxaldehyde ('HICC'), as well as a number of permissible ingredients relating to Ispaghula, Plantago, Psyllium, Cymbopogon and Malus species. A total of 4 consultation submissions were received in response, from: Accord Australasia, Complementary Medicines Australia, Consumer Healthcare Products Australia, and Naturopaths and Herbalists of Australia. All comments received for this consultation have now been considered and the changes will commence on 2 March 2020.    Sources: Permissible ingredients changes & Permissible ingredients determination

Comparable Overseas Bodies (COBs) for Complementary Medicines

The TGA makes use of assessments from comparable overseas bodies (COBs), where possible, in evaluations for complementary medicines and listed OTC medicines (e.g. sunscreens). In response to the Medicines and Medical Devices Review (MMDR) the TGA has implemented transparent criteria for identifying comparable overseas bodies (COBs), as well as a process for using reports from nominated COBs. The TGA can use evaluation reports from comparable overseas bodies (COBs) to evaluate registered complementary medicines assessed listed medicines and substances for use as ingredients in listed medicines.    Source: COBs for CMs

TGA Training Course - Evidence Requirements for Listed Medicines

This online training resource is designed for sponsors of listed medicines and aims to supplement the information in the Evidence Guidelines for Listed Medicines. It also seeks to provide additional information in response to common questions and issues encountered by sponsors. It is helpful to have a copy of the Evidence Guidelines for Listed Medicines available to you for reference when completing this 30 minute module.   Source: Evidence training module     [For more comprehensive training for complementary medicine regulations please see courses listed on our website: RFA Training Courses ]

Technical Guidance on Medicinal Cannabis Manufacture

In 2016 the Australian Government amended the Narcotic Drugs Act 1967 to allow the cultivation and production of cannabis for medicinal purposes. This guidance is for manufacturers of medicinal cannabis products. It outlines and provides information on manufacturing license and certification requirements; differences between the TGA and the Office of Drug Control (ODC) requirements; and TGA interpretation and expectations for compliance with specific sections of the current PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products (PIC/S Guide to GMP).     Source: Medicinal cannabis manufacture

TGA Safety Advisories- Source: TGA current year alerts

Kulchaya Sheaya Lender capsules: The capsules contain the undeclared substance fluoxetine.

Black Storm tablets: The tablets contain the undeclared substance sildenafil.

Brauer Teething Gel 20g:  One batch of Brauer Teething Gel 20 g due to bacterial contamination.

NZ Assesses Impact of Medicinal Cannabis Scheme

New Zealand’s Ministry of Health has issued a paper detailing the regulatory impact of the Medicinal Cannabis Scheme which enables domestic cultivation and manufacture of medicinal cannabis, and the import of overseas products. Regulations specific to medicinal cannabis are required to establish the scheme. These will set minimum quality standards for products and set medicinal cannabis licensing requirements. The impact assessment provides supporting analysis for the Cabinet paper seeking approval for policy decisions required to draft the medicinal cannabis regulations.    Source: NZ medicinal cannabis

Conflict of Interest: Top Medical Journal takes on Big Pharma

A leading medical journal (The BMJ) is launching a global campaign to separate medicine from big pharma, linking industry influence to the pelvic mesh scandal that injured hundreds of women in Australia. The BMJ says doctors are being unduly influenced by industry-sponsored education events and industry-funded trials for major drugs. Those trials cannot be trusted, the journal's editor and a team of global healthcare leaders write in an editorial published earlier this month.    Sources: Liam Mannix, SMH Big pharma & Cochrane study

Potential Herb-Drug Interactions for Commonly Used Herbs

While many useful databases are commonly held behind expensive paywalls, this publicly available chart from Mediherb is easy to read, simple to print and acts as a helpful reminder of what can happen when herbal medicines and prescribed drugs interact in the human body.    Source: Herb-drug interactions

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Examines Saw Palmetto and Oregano

The American Botanical Council – American Herbal Pharmacopoeia - National Center for Natural Products Research collaboration has recently published two papers examining product substitution of saw-palmetto (Serenoa repens) and oregano (Origanum vulgare subsp. hirtum, or O. onites). This is the 19th in the series of the Botanical Adulterants Prevention Bulletin (BAPB) and underlines the widespread dilution and/or substitution of herbal ingredients in the supply chain.    Sources: Saw palmetto lab guidance & Oregano substitution

RFA Breaking News

Complementary medicines ('Dietary supplements')

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Complementary medicines ('Dietary supplements')

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Foods

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