Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

Australian Natural Healthcare and Wellbeing Snapshot

The domestic Australian complementary medicine industry is robust and significant . Market research shows that the popularity of complementary medicines is increasing with a growth rate of seven per cent year on year. Three-quarters of Australians, including 92 per cent of women aged 20-24; take at least one complementary medicine and a quarter of the population visit complementary healthcare practitioners each year. In Australia, the fastest growth areas are nutritional oils, men’s health and eye health. Products are manufactured to some of the highest standards in the world based on GMP validation and stringent therapeutic regulations. These standards are maintained by the Therapeutic Goods Administration (TGA) through a transparent approval process, strict manufacturing compliance guidelines and effective post-market monitoring. The TGA register also supports the complementary medicine industry with evidence-based research, monitoring and safety data. These elements combine to allow Australian manufacturers to supply world-class products at globally competitive prices.   Source: Austrade snapshot

 

Quote for the month:

“Stay away from negative people; they have a problem for every solution”   Albert Einstein

 

 

Listed Medicine Compliance Rating Scheme Has Begun

The TGA’s Listed Medicine Compliance Rating Scheme commenced on 28 November 2018 as part of its existing compliance review process. As listed medicines are not evaluated by the TGA before they are included on the Australian Register of Therapeutic Goods (ARTG), they conduct post-market compliance reviews on a proportion of those on the ARTG each year to ensure their ongoing safety, quality and efficacy. To support the publication of review outcomes on the TGA website, they have developed a Listed Medicine Compliance Rating Scheme (the Scheme). The Scheme is intended to aid consumers in interpreting the outcomes of compliance reviews after they get published on the TGA website. This will enable consumers to make informed choices about their use of self-selected medicines and provide an incentive for sponsors to improve overall compliance of their products.   Source: Compliance rating scheme

TGA Fines Company Over $25,000 for Alleged Importation of Unapproved Therapeutic Goods

Australian company ESCHOICE Pty Ltd will pay penalties of over $25,000 after the Therapeutic Goods Administration (TGA) issued infringement notices for the alleged importation of unapproved therapeutic goods, namely medicines and medical devices for use in cosmetic procedures. Australian Border Force officers seized the imported therapeutic goods as part of Operation Antlia, a compliance initiative of the TGA. The TGA initiated Operation Antlia to target the illegal use of therapeutic goods in the cosmetics industry after a woman died from a cosmetic procedure at a Sydney clinic last year.   Source: Operation Antlia

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation in December 2018. A total of 6 changes have been made in the updated Determination. These changes include changes to 5 existing ingredient entries, including making requirements clearer and less restrictive; and, removal of 1 ingredient that was a proprietary formulation and incorrectly classified as being appropriate for use in listed medicines during the drafting of the original Determination. The removed ingredient is not currently used in any listed medicines in Australia.    Source: Permissible ingredients

TGA Consultation: Remaking Therapeutic Goods Order No. 78

The TGA is seeking comments from interested parties on the proposed remaking of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules and reintroducing pills into the remade Order. This consultation closes on 8 February 2019.    Source: TGA 78 consultation

TGA Reviews the Narcotic Drugs Act 1967

The Narcotic Drugs Act establishes a framework to both prevent abuse and diversion of controlled narcotics and to ensure the availability of such drugs for medical and research purposes, in accordance with the Single Convention on Narcotic Drugs. Since October 2016, the Act was extended to provide for the regulation of cannabis cultivation and production in Australia, to enable a sustainable supply of safe medicinal cannabis products for therapeutic purpose.    Source: Narcotics review

TGA Takes Action Against Peptide Clinics Pty Ltd for Alleged Advertising Breaches

The Secretary of the Department of Health has begun Federal Court proceedings against Peptide Clinics Pty Ltd, trading as Peptide Clinics Australia, alleging breaches of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2015 (the Advertising Code). This legal action follows an investigation by the Therapeutic Goods Administration. Peptide Clinics Australia is alleged to have advertised compounded prescription only therapeutic goods, including 'peptides', on its website and other social media platforms, accessible to both registered customers and the public. It included references to serious forms of diseases, and to conditions such as anxiety and depression.    Source: Peptide Clinics busted

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

THAN YOU tablets: the tablets contain the undeclared substance sibutramine.

NZ Therapeutic Products Regulatory Scheme Consultation

New Zealand’s Ministry of Health is seeking feedback on the draft Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. Please note that Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process.   Source:  NZ Therapeutic products bill

AHPA Issues Status Report on Hemp and CBD After USA Farm Bill Passage

The American Herbal Products Association has produced a Status Report after working with legal and industry experts to develop a new, free resource titled Status Report: Marketing of hemp and cannabidiol (CBD) products in the United States, following passage of the 2018 Farm Bill. This document provides concise and up-to-date information on the status of such operations and products as soon as this legislation is adopted as federal law. Because of the herbal product industry’s broad interest in the impact of this legislation on hemp and CBD, AHPA is distributing this information before the bill has been signed into law. The 2018 Farm Bill has been passed by the Senate and House, but still needs to be signed into law by the President. AHPA is not aware of any indications that successful and timely completion of this is in doubt.   Source: 2018 Farm Bill passage

 

 

Australia, New Zealand and Pacific Island Beauty Brands Capitalise on Indigenous Ingredients

Australia and New Zealand may be saturated markets for the cosmetics and toiletries industry, but consumers’ willingness to buy a variety of complex formulated and premium green products is continually expanding revenue. Millennial consumers especially are contributing to rising demand for independent and green brands.     Source: Excerpt article from Barbara Barkhausen, Cosmetics Business Cosmetics downunder

 

Quote for the month: 

“Christmas is not a date. It is a state of mind”   Mary Ellen Chase

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Employment Opportunity: Regulatory Affairs Associate

RFA Regulatory Affairs is looking for a Regulatory Affairs Associate who has at least 1-2 years' experience, to join our team of regulatory associates in our Glebe office. We provide regulatory advice for complementary medicines, sunscreens, foods, cosmetics, and some medical devices. We also provide advice to manufacturers preparing for TGA GMP audits, and new product development for complementary medicines and some types of foods.

Click here to read more

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Nordoff-Robbins Music Therapy Corporate Christmas Cards

As per our usual practice, this year we are donating to Nordoff-Robbins Music Therapy (www.nordoff-robbins.com.au) in lieu of sending Christmas cards to clients. Nordoff-Robbins Music Therapy uses music to transform lives and bring the benefits of music therapy to those in need. You can also donate http://www.noro.org.au/support-us/donate-now. RFA Regulatory Affairs is a long-time supporter of Nordoff-Robbins Music Therapy Australia.  http://www.noro.org.au/about/our-supporters  You can be too!

 

Australian Ministers Confirm Phase-out of Microbeads in Cosmetics

The Meeting of State Environment Ministers (MEM) recently took place and as part of an overall action plan on waste management have reaffirmed their commitment to the complete phase-out of solid plastic microbeads in cosmetics and personal care products.    Source:  Plastic microbeads

 

 

Summary of Changes to the Therapeutic Goods Advertising Code 2018

The Therapeutic Goods Advertising Code (No.2) 2018 (the No.2 Code 2018) will commence from 1 January 2019. Key changes include: delaying commencement of certain health warnings; streamlining definitions; providing transitional arrangements for pre-approved advertisements; streamlining general requirements for advertisements; clarifying requirements for scientific or clinical claims; and, clarifying requirements relating to consistency with public health campaigns.   Source: Advertising code update

Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

Advertising of therapeutic goods requires a higher ethical standard than may apply for ordinary consumer goods. Determining the appropriateness of a therapeutic good can be difficult for a consumer and it is important that promotional material is truthful, balanced and not misleading. Advertising should give adequate information on the risks and cautions around a product and recommend to seek health professional advice where appropriate. As a result there is specific legislation that applies to the advertising of therapeutic goods to consumers (over and above Australian Consumer Law, which regulates advertising generally). The regulation of advertising reflects the importance of consumers being properly informed so that they can select treatment options appropriately for use in their own and their family's healthcare.   Source: Advertising to the public

TGA Advertising of Therapeutic Goods: Education, Training and Events

A suite of educational materials is being developed to help advertisers understand the legislation relating to advertising therapeutic goods. These materials include online learning modules, videos, webinars and presentations and will be updated as new information and training materials become available.   Source: TGA training   (See also: RFA Regulatory Affairs training courses)

TGA Advertising Guidance: Sample Social Media Acceptable Use Policy

The TGA acknowledges that social media provides a valuable platform for sharing views about products, but there are important considerations around therapeutic goods. To help advertisers comply with the Therapeutic Goods Advertising Code, the TGA has provided a social media acceptable use policy that advertisers can use on their digital platforms. This policy sets out guidelines to ensure any comments, endorsements or testimonials are not misleading or encourage the inappropriate use of a product. To use the policy, suppliers can simply copy and paste into the 'About' tab on their own social platforms and be sure to moderate any comments that may result in them breaching the Code.   Source: Acceptable use policy

TGA Updates Medicine Ingredient Names

In different countries, different names are used to describe the same medicinal ingredient. Over the years, some medicine ingredient names in Australia have become out of date. This can be confusing for Australian consumers and healthcare professionals who travel internationally, as well as people like doctors who have trained overseas or people trying to access medicine information online. The TGA is updating some medicine ingredient names used in Australia to align with names used internationally. The four year transition period for these changes has started and will end in April 2020.   Source: Medicine ingredient naming

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Li Da Weight Loss Capsulesthe capsules contain the undeclared substance sibutramine.

Chapter Plus+ By Backslim Capsules: the capsules contain the undeclared substance sibutramine.

Canberrans Warned of Dangerous and Unknown Substances in Sport Supplements

Australian Capital Territory Chief Health Officer Dr Paul Kelly, said ACT Health is currently investigating the sale of sports and other supplements in the ACT, following complaints to the Health Protection Service. “The products are being sold locally and primarily through sports supplement stores, which is why this is so concerning and why Canberrans need to be warned. These substances are banned for a reason. They pose a significant health risk and for the majority of these substances there is no legitimate medical use”. The sport supplement products that have been found as part of the investigation, are labelled to contain substances, such as selective androgen receptor modulators (SARMs), cardarine, tadalafil, oxedrine, melatonin and phenibut.   Source: Sports supplements warning . (Editor’s note: Seems that USA has similar problems, especially with ‘phenibut’ Phenibut warning )

Medical Devices: Hearing Aid Retailers Fined $2.5 Million for Misleading Pensioners

The Federal Court has ordered hearing aid retailers Oticon Australia Pty Ltd (Oticon) and Sonic Innovations Pty Ltd (Sonic) to pay penalties totalling $2.5 million for misleading pensioners through newspaper advertisements for hearing aids sold by AudioClinic and HearingLife clinics. In addition to paying penalties of $2.5 million, the Court ordered by consent that Sonic and Oticon offer refunds to customers who purchased ConnectLine and SoundGate3 accessories, publish a corrective notice in a nationally circulated newspaper, and establish an Australian Consumer Law compliance program.   Source: Hearing aid penalty

NZ Natural Health Products Back on Political Agenda

In June 2018, New Zealand First MP, Mark Patterson, submitted a member’s bill to replace the Natural Health and Supplementary Products Bill which lapsed shortly before last year’s election and was not reinstated when Parliament resumed. Mr Patterson has since withdrawn his bill, after he was contacted by the minister’s office and told the ministry was already working on new rules for natural health products. Health minister David Clark has asked for advice on new legislation for natural health products. Currently, natural health products are controlled as medicines or under Dietary Supplements Regulations 1985. Industry group Natural Health Products NZ has been a vocal proponent of the need to update the legislation, which it sees as an impediment to business. Dr Clark was not available for an interview, but, in a statement to Pharmacy Today, confirms: “The Government has agreed to develop legislation of its own on this matter.”   Source: NHPNZ, NZ NHP Bill

Renewed Warning of Liver Harm from Artemesia annua

The New Zealand Director General of Health is renewing a public warning following more reports of serious liver harm from taking Arthrem and other products containing Artemisia annua extract. An initial alert in February this year was a result of 14 reports of liver harm linked to the use of Arthrem, a natural product available for sale and other similar products. Since then there have been an additional 11 reports, some showing serious harm. Some of these new reports may have been from people taking these products earlier, but they may also have been from people continuing the take the product. Artemisia annua extract (also known as Sweet Wormwood, Sweet Annie or Qing hao) is marketed as a natural dietary supplement for maintaining and supporting joint health and mobility. Several products containing Artemisia annua extract are available in New Zealand.   Source: NZ liver warning

New Technique to Eliminate Adulteration of Ginkgo Biloba Leaf Extracts

Network Nutrition, a division of IMCD and supplier of specialised plant derived natural-healthcare ingredients, has recently published its scientific research into the numerous mechanisms for the adulteration of Ginkgo biloba leaf extracts. The research includes careful examination of the latest and most sophisticated mode of adulterating this popular herbal material, being the inclusion of an entirely different plant species; Styphnolobium japonicum (syn. Sophora japonica). The paper, published in the journal Fitoterapia, involved a comprehensive independent analytical screen of 22 finished products purchased in the European, Australian and New Zealand retail sectors. It was discovered that 14 out of 15 (93%) of the finished products purchased in Europe contained adulterated Ginkgo extract, whilst this was true for 2 out of 7 (28.5%) of those purchased in the Australian and New Zealand markets. The research discusses the hotly debated presence or absence of genistein; an isoflavone compound, and whilst some scientific circles elude to the natural occurrence of this compound in Ginkgo leaf, the research provides expanded analytical tools to determine the source of any genistein present.   Source: Elsevier Gingko study

Botanical Adulterants Prevention Program Publishes Cranberry Laboratory Guidance Document

The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of nonprofit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about the various challenges related to adulterated botanical ingredients sold in commerce. This new publication evaluates analytical methods to authenticate cranberry fruit materials and detect adulteration with anthocyanin- or proanthocyanidin-rich extracts from other plant species.   Source: ABC Herbalgram Cranberry adulteration

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