Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines and Medical Devices:
TGA conducting forum on GMP
Half yearly performance snapshot: July to December 2020
The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the financial year and is available on the TGA website. This Half Yearly Performance Snapshot provides statistical information for the period 1 July 2020 to 31 December 2020 in relation to the regulation of therapeutic goods, tracking of progress against some of the priorities identified for the year. This data will be incorporated into the Annual Performance Statistics Report for the 2020-21 financial year, to be published on the TGA website in the second half of 2021. Source: TGA news
Update on the poisons scheduling of psilocybin and MDMA
An independent review has been commissioned into the therapeutic value, risks and benefits to public health outcomes for these substances. Amended timing on the scheduling process for these substances will be published on the TGA website following the completion of the independent review. Source: TGA
Changes to regulation of nicotine e-cigarettes
These changes affect nicotine e-cigarettes, nicotine vaping products (also known as eJuice, vape juice, eLiquid), and novel nicotine delivery systems, such as heat-not-burn tobacco products. They do NOT affect nicotine replacement therapies, such as sprays, patches, lozenges, chews and gums, or e-cigarette products that do not contain vaporiser nicotine. From 1st October you will no longer be able to legally buy these products from overseas websites without first talking with a GP and getting a prescription. These products cannot be sold anywhere in Australia without a doctor's prescription, and the possession and use of these products without a prescription is illegal in all states and territories except South Australia. Between 2015 and 2019, e-cigarette use by young people increased by 96 per cent in Australia. There is evidence that nicotine e-cigarettes act as a 'gateway' to smoking in youth and exposure to nicotine in adolescents may have long-term consequences for brain development. Source: TGA
Advertising health services
An advertisement for a health service is not considered an advertisement for therapeutic goods, unless you refer to therapeutic goods used in the delivery of the service in the advertisement. Products mentioned in this summary guide include cosmetic injectables, medicinal cannabis, compounding pharmacies, vaccine providers, biologics, and more. Source: TGA
Decisions to amend, or not to amend, the poisons scheduling of certain substances as at 22nd April
This mentions substances that have had their poisons scheduling amended, and those that have not been changed, and discusses the reasons for the decisions. Includes amygdalin and hydrocyanic acid, bilastine, budesonide and formoterol, azoxystrobin, triticonazole, azelaic acid, 2-hydroxyethyl methacrylate (2- HEMA), magnesium hydroxide, tetrahydrofurfuryl alcohol, cannabidiol. Source: TGA
Supply and wholesaling of medicinal cannabis products (MCP)
Both sponsors of products, and other persons who are not the sponsor, are prohibited from supplying unregistered MCP by wholesale. This guide summarises the compliance obligations associated with the storage and supply of the products. Source: TGA
Regulation of medical device software
This is a TGA presentation delivered at an industry masterclass. When is software a medical device? A summary of reforms and international alignment. Source: TGA
TGA case studies
The TGA is publishing case studies to provide examples of how regulations are enforced.
Food-medicine interface: the example given is a complaint about advertising which presented products as formulated supplementary sports foods, but included claims of a therapeutic nature, including conditions such as depression and autoimmune conditions. The company did not take sufficient action after being contacted by the TGA, so was issued infringement notices totalling $301,400 for 21 counts of advertising therapeutic goods not on the ARTG, two counts of using a prohibited representation and one count of using a restricted representation without TGA authorisation. The company paid the infringement notices.
Homeopathic melatonin: the product was not prepared according to homoeopathic principles and the amount of melatonin present was not sufficient to justify the claims. It was decided that describing these medicines as homeopathic melatonin could be misleading.
Weight loss products: the example given here is one of the “FatBlaster” products. The sponsor of the product could not provide satisfactory evidence to support the claims being made. The product was cancelled on 20 December 2019.
Restricted representations: multiple complaints were received about BioCharger, a medical device that emitted light, but was not included on the Australian Register. Claims on Facebook implied the BioCharger was capable of having an effect on COVID-19, as it was 'programmed with about a thousand different recipes, there's a couple on there for Wuhan coronavirus'. The company website contained other therapeutic claims. The company paid two infringements notices totalling $25,200. The device was being sold for $15,000.
Cosmetics, Personal Care and TGA Listed Sunscreens:
Conditions placed on sunscreens that were tested by AMA Laboratories in the USA.
Sunscreens must be tested to validate the SPF claims. In August 2019 the US FDA announced that several executives and supervising laboratory technicians of AMA Laboratories had pleaded guilty to fraudulent laboratory testing. In September 2020, the TGA contacted all sponsors of Australian sunscreens notifying them of its post-market review of sunscreens. Sponsors must provide adequate justification for ongoing supply of products that have been tested by AMA Laboratories, such as additional supportive testing data conducted by an independent testing laboratory. Source: TGA
A list of chemicals added to the Inventory 5 years after issue of assessment certificate
AICIS has released a list of chemicals added to the database from 23rd February to 10th March 2021. Source: AICIS news.
Guide to categorisation of fluorinated chemicals
This is relevant to importers of products that are fluorinated chemicals. A fluorinated chemical is a chemical that contains one or more fluorine atoms. Source: AICIS
Soap making and importing
This is a useful guide for importers and manufacturers of soaps and explains when you need to register your business details. It includes information on the processes used to make soaps, and soaps made from natural or organic ingredients. Source: AICIS
Banned or restricted chemicals
Bans and restrictions on chemicals and consumer product ingredients – including cosmetics – are regulated by each state and territory authority. This explains how different chemical are regulated, and lists over 10 different government authorities that may be involved including The Standard for the Uniform Scheduling of Medicines and Poisons, The Therapeutic Goods Administration, The Australian Pesticides and Veterinary Medicines Authority, Food Standards Australia and New Zealand, The Department of the Environment and Energy, Safe Work Australia, The National Transport Commission, Australian Border Force, The Australian Competition and Consumer Commission and Australian National Security. Source: AICIS
Complementary Medicines and Medical Devices:
Artemisia annua and Artemisia absinthium updated product recalls
A further 8 products have been cancelled and recalled. It seems there is an unacceptable risk if these products are used during pregnancy, and the cancelled products did not include the mandatory label warning statement about pregnancy. Source: TGA News
Updated guide to medicine labelling requirements
This is an updated guide to the two labelling orders Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) (including complementary medicines). Source: TGA guidance document
Industry Forum on Good Manufacturing Practice (GMP)
TGA has announced the third GMP forum, which will be held over three half days on Wednesday, 12 May - Friday, 14 May 2021. This will be a virtual event and it will be free to attend. TGA states “This Forum will be of interest to industry personnel involved in the quality assurance, regulation, risk assessment and good manufacturing practice of medicines and biological products.” Source: TGA news
Changes to ingredients permitted in listed medicines
This is a summary of the changes to 169 ingredients. Source: TGA news
TGA compliance activity
CW IP Pty Ltd fined $53,280 for alleged advertising breaches on the Chemist Warehouse and My Chemist websites. They allegedly advertised Fatblaster Clinical capsules, a therapeutic good, on four pages of its Chemist Warehouse and My Chemist websites. At the time of advertising, Fatblaster Clinical capsules were not entered in the Australian Register of Therapeutic Goods. The TGA cancelled Fatblaster Clinical capsules from the ARTG on 20 December 2019. Source: TGA news
Newcastle-based retailer Junction Rx trading as My Community Pharmacy (Junction Rx) has been issued an infringement notice for $13,320 for alleged advertising of an unlisted complementary medicine after they failed to comply with a cease and desist notice by the set deadline. They advertised a therapeutic good called ‘FatBlaster Apple Cider Vinegar and Garcinia Max' which is not included on the Australian Register of Therapeutic Goods. Source: TGA news
Epharmacy Group fined $26,640 for alleged unlawful advertising on the ePharmacy website. The fines were issued for the alleged unlawful advertising of Fatblaster Clinical, a complementary medicine cancelled from the Australian Register of Therapeutic Goods. Source: TGA News
Bulk Buys fined $13,320 for alleged unlawful importation of surgical face masks. TGA claims they breached a condition of the Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 by importing surgical face masks that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile. Source: TGA news
Medicine packaging definitions
A useful guide to understanding packaging terms which do not always align between different regulations. What is the difference between “primary packaging” and “primary pack”? What is “tertiary packaging”? Source: TGA
New standard for serialisation and data matrix codes on medicines
1st January 2023 is the commencement date for the new Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021. This order does not make the use of data matrix codes or serialisation of medicines mandatory, but sets out requirements if medicine sponsors choose to do either of these. Medicines must comply with TGO 106 by 1st January 2023 if they are serialised, or include a dot matrix code that encodes the Global Trade Item Number (GTIN). Sources: TGA news, and Federal Register of Legislation
Medical devices – essential principles checklist
Available in either word or pdf format – this 28 page checklist will be very helpful for sponsors of medical devices. It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices. Source: TGA news
Standard for unapproved vaporiser nicotine products
TGA is proposing a standard and proposed safety and quality requirements. This is a copy of an online presentation. Source: TGA news
Post-market review of face masks
The TGA is continuing its review of face masks and this page summarises the findings. The TGA states some … “are not performing as intended, i.e. as claimed by the manufacturer. Some masks may pose a risk to public health and safety when used in healthcare settings or industrial / commercial settings where protection from contaminated fluids and airborne particulates is required”. Some products require no action, some have been cancelled, others need corrective action. Source: TGA face mask review
Summary of a recent online presentation on medicinal cannabis advertising compliance has been published. TGA presented along with professional experts. Find it here.
Review of the 2013 Australian Dietary Guidelines
The National Health and Medical Research Council (NHMRC) has received $2.5 million from the federal government to review the guidelines. The first step will be a scan of the latest nutrition science research and evidence. Source: NHMRC.
Advertising of “toddler milk”
The Victorian Health Department is calling for an end to aggressive marketing of toddler milk formulas, as new research reveals some products are up to four times more expensive than regular milk, but with more sugar and fewer key nutrients. Also, the Australian Competition and Consumer Commission (ACCC) proposes to re-authorise a longstanding agreement by manufacturers to not promote infant formula, to protect rates of breastfeeding. There is concern the industry is trying to “work around” the restriction on infant formula advertising by promoting “toddler milk”. Source: VicHealth and ACCC
New Zealand man fined for biosecurity breaches
An Auckland businessman Sanjive Ramavtar Kapoor from Divine Logistics was sentenced after pleading guilty to three charges which included unauthorised opening of shipping containers and falsifying documents. Mr Kapoor redirected containers from Approved Transitional Facilities 22 times between 21 June 2018 and 31 January 2019. Mr Kapoor admitted to opening and unpacking 12 of these containers. He was fined NZ$30,000. Source: New Zealand Ministry of Primary Industries.
Declaration of allergens on food labels – changes
There is a move to plain English labelling. There are some new allergens, “nuts” or “tree nuts” must now contain the names of these nuts, specific cereals must be listed by name rather than grouped together as “cereals” – and many other changes .Summary of work to date can be found here, here, and here. Source: FSANZ. Relevant legislation is here.
Failing food report for January 2021
This report lists food that has failed under the Imported Food Inspection Scheme (IFIS) during January 2021. Table 1 shows results of tests on rick foods. Salmonella, E. coli, aflatoxin and histamine levels remain a problem. Table 2 lists other surveillance issues, including non-permitted additives. Source: Dept Agriculture.
Approvals and amendments to the Food Standards Code
A1204 – Beta-amylase from soybean (Glycine max) as a processing aid (enzyme)
P1051 – Code Revision (2020)
A1555 – 2’-FL and LNnT in infant formula and other products
A1175 – Rapeseed protein isolate as a novel food
A1180 – Natural Glycolipids as a preservative in non-alcoholic beverages
A1186 – Soy Leghaemoglobin in analogue meat
FSANZ has published a summary of food recalls over the last 10 years. The main reasons for recalls were microbial contamination, labelling, foreign matter, chemical/other contaminants, undeclared allergen, biotoxin and “other”. During 2020, there were 33 recalls due to undeclared allergens. FSANZ Sources: recalls due to allergens, current food recalls.
Facts sheet on GM Foods
How they are made, labelling, and what types of GM foods are sold in Australia and New Zealand. Source: FSANZ
Cosmetics and TGA Listed Sunscreens:
Kimberley-Clark fined $200,000 for misleading country of origin statement
The website claimed the products were made in Australia. Source: ACCC
Correction of chemical names – updated to terminology. Source: AICIS
New Industrial chemicals – guide to preparing report
Guide to completing the most common type of pre-introduction report (PIR) – ‘highest indicative risk is low risk’. Source: AICIS