Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 – Update
The Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 was registered on the Federal Register of Legislation (FRL) on 15 June 2018. Changes include - Addition of 9 new excipient ingredients with associated requirements relating to their use; Changes to 75 existing ingredient entries; and, Removal of 4 ingredients. The TGA has included an 18-month transition period for most changes to the Permissible Ingredients Determination. Consequently, the new Determination includes transitional arrangements for existing medicines that are currently listed in the Register to comply with some new requirements for ingredients. The transitional provisions do not apply to new products that are entered into the Register. The transition period ends on 1 January 2020. Source: Permissible ingredients 2018
Australian Government Specifies Cannabis Import / Export Controls
The Office of Drug Control (Dept. of Health) has detailed the conditions that some cannabis products may be imported and exported from and to Australia. Export is permissible for ‘medicinal cannabis products manufactured in Australia under a GMP licence’; for ‘medicinal cannabis products listed as export-only, or registered, on the Australian Register of Therapeutic Goods (ARTG)’; & for ‘extracts of cannabis (or extracts of cannabis resin) manufactured under a Narcotic Drugs Act 1967 licence and permit that are not in the final dosage form’. For Imports, ‘approval must be granted by the national governments of both the importing and exporting countries before shipment can occur. Food grade/nutritional products derived from hemp may not meet Australian manufacturing requirements’. Source: Medicinal cannabis
Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015. The guidance for the proposed Therapeutic Goods Advertising Code 2018 is still under development and will be consulted on from mid-June 2018. Source: Advertising medicines
TGA Fees and Charges From 1 July 2018 Summary
For a complete summary of the latest fees and charges for non-prescription medicines, listed medicines (including for export only), registered complementary medicines and the newly established ‘assessed listed complementary medicines’, please visit this site. Source: Non-prescription medicines Manufacturing inspections and GMP clearance fees can be read here: Manufacturing fees
TGA Safety Advisories— Source: https://www.tga.gov.au/current-year-alerts
Solve Botanical Slimming capsules: contains furosemide (frusemide), phenolphthalein and paracetamol.
Meltz – Instant Energy For Males tablets: contains the undeclared substance vardenafil.
Bulbao Male Enhancer tablets: contains the undeclared substances sildenafil, tadalafil and yohimbine.
Platinum - Male Enhancer capsules: contains the undeclared substances sildenafil, sulfosildenafil and sulfoaildenafil.
Camellia sinensis (green tea) extract (potential risk of harm to the liver!)
Consumers and health professionals are advised that rare cases of harm to the liver have been associated with products that contain Camellia sinensis (green tea) extracts. Medicines containing C. sinensis extracts have been associated with a number of cases of liver toxicity world-wide, although the incidence appears to be rare and unpredictable. The majority of C. sinensis use (including green tea in beverage form) is unlikely to cause harm, therefore the TGA considers that a recall of C. sinensis products is not warranted. The underlying reasons why liver injury has occurred are not well understood at this stage. Twenty adverse events have been reported to the TGA associated with both C. sinensis-containing products and liver injury. All but one of these events involved products containing concentrated extracts of the ingredient. Most cases (17) involved multiple suspected products and/or multi-ingredient products. In three cases, the sole suspected product contained C. sinensis as the only active ingredient. Source: Green tea risk
TGA Outlines the Future Regulation of Low Risk Products
The Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applied to a range of products that represent a very low safety risk to consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products. The status quo will prevail for ‘Water soluble vitamins and minerals, as well as for sunscreens’. Products which are changing include: Tampons and menstrual cups (exempt goods); Nappy rash creams / treatments (exempt goods) (only if they are currently listed or Class 1 devices, but not if they are currently registered); Hard surface disinfectants - exempt goods (if currently listed as hospital grade without specific claims), but registered hard surface disinfectants with specific claims will be moved from the registered to listed other therapeutics goods (OTG); Antiperspirants (excluded); and, Ear candles (excluded). Source: Low risk products
TGA Updates the Listed Medicines Application & Submission User Guide
Do you want to prepare an application to list a medicine? Then this latest guide is just for you. Most listed medicines are complementary medicines, such as: vitamin and mineral formulations, herbal preparations, homeopathic preparations, and essential oils. The TGA Business services (TBS) portal provides an electronic facility for the listing of medicines on the Australian Register of Therapeutic Goods (ARTG). All necessary tools required to lodge, change and maintain an application for a listed medicine are accessible via TBS. This guide is intended to be used as a step‐by‐step description of each process of the application and submission process. Each section will outline the functionality and describe how each section should be completed. Source: DIY listed medicines
Editor’s note: Please remember that if you get stuck, you can always try one of our own in-house training courses via http://www.rfaregulatoryaffairs.com/training-courses or failing that, engage with us directly and we can do all of the work for you. www.rfareg.com
Turmeric Adulteration Bulletin
Jointly published by the American Botanical Council (ABC), American Herbal Pharmacopoeia (AHP), and the National Center for Natural Products Research (NCNPR), the Botanical Adulterants Prevention Program has recently highlighted the widespread practice of adulteration of global turmeric (Curcuma longa rhizome) supplies. Few herbal dietary supplement ingredients have seen such a steep sales increase over the past five years as turmeric. Turmeric has been the top-selling dietary supplement in US natural food stores since 2013, and it ranked fifth in sales in mainstream retail outlets in 2017. The new bulletin, written by Ezra Bejar, PhD, an expert in botanical research in San Diego, California, lists the known adulterants, details analytical approaches to detect adulterants, and provides information on the nomenclature, cultivation, harvest, and market importance of turmeric. Source: Turmeric bulletin