RFA Regulatory Affairs - Latest Regulatory Affairs Newsletter

Latest Regulatory Affairs Newsletter

Consultant,

A collection of regulatory news from this month.

Many Suppliers of CMs Caught Out by New TGA Regulations

Suppliers of complementary medicines (CMs) in Australia are in danger, of having their products cancelled as important statutory deadlines draw near. The key dates for the changes affecting listed medicines (LMs) are: 1st September 2020 when labels must comply with Therapeutic Goods Order (TGO) 92; and 6th March 2021: when, in order to avoid cancellation, products must only use indications included in the list of pre-approved ‘permitted indications’. RFA Regulatory Affairs has noticed that many current suppliers of LMs have not yet transitioned to using permitted indications and are in danger of having their products cancelled. To assist with this, we are offering a three-step service to get your product in compliance. This includes:

developing an evidence package for your product based on TGA permitted indications;
revising your label to include only TGA permitted indications and complying with TGO 92; and,
revising your product AUST L listing to only include permitted indications.

You can choose 1-3 or any of the above, which we are offering at a reduced rate. Contact Robert for rates at This email address is being protected from spambots. You need JavaScript enabled to view it.

RFA Regulatory Affairs also provides training modules to help you become compliant in these areas, offering training on label compliance and preparation of evidence packages. For further details about this and all of our training courses, visit RFA Training Courses .

Caffeine Restrictions – Interim Decision and Invitation for Further Consultation

Regular readers of this newsletter will be aware that due to the recent appearance on the Australian market of highly concentrated caffeine products and one reported death, the TGA has been enacting legislation and consulting with industry, in order to restrict the way that these highly concentrated caffeine products can best be managed. In 2019, the TGA began a “first round” restriction of caffeine by making restrictions within the Permissible Ingredients Determination, which affect Listed medicines only. Among other changes, the TGA imposed a limit of 33% of caffeine in divided preparations such as tablets and capsule, and undivided preparations have been restricted to 4%, with an upcoming further restriction to 1% in 2021. Currently, there is a ‘second round’ review of restrictions for caffeine that is occurring via the Scheduling mechanisms which results in inclusion of caffeine in the Poisons Standard. Changes here affect the use of caffeine more widely and can also influence both Listed and Registered OTC medicine policy. On 6 February 2020, an interim decision and invitation for further comment was announced by the TGA. The interim Scheduling decision is open for consultation and will close on 5 March 2020. Source: Scheduling of chemicals and poisons (caffeine)

Meeting the Evidence Requirements for Marketing of Medical Devices

This guidance provided by the Therapeutic Goods Administration (TGA), assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation. To supply a medical device in Australia, sponsors need to submit a market authorisation application to the TGA to include their medical device in the Australian Register of Therapeutic Goods (ARTG). Source: Medical device evidence (Please also see: Australian regulatory guidelines for medical devices).

Australian Company Fined for Supply and Advertising of Unapproved Dermapen Device

InSkin Cosmedics Group Pty Ltd has paid penalties of $37,800 for the supply and advertising of the Dermapen 4, a medical device that was not included on the Australian Register of Therapeutic Goods (ARTG). Australia's therapeutic goods legislation prohibits the import, export, manufacture, supply and advertising of therapeutic goods for human use that are not included in the ARTG or otherwise the subject of an exemption, approval or authority. Source: Microneedling fail

Reminder - Changes to Permissible Ingredient - Andrographis paniculata

In 2015, the TGA completed a safety review of Andrographis paniculata and anaphylactic/allergic reactions. Since then, the TGA has received a further 70 Australian reports of allergic reactions related to Andrographis paniculata and an additional 37 reports of anaphylaxis. For 11 of these cases, the sole suspected medicine contained Andrographis paniculata as the single active ingredient, with 4 of the 11 cases involving anaphylactic reactions. The TGA is aware of an additional 193 international reports which detail similar allergic-type reactions in relation to medicines containing Andrographis paniculata. Due to the risk, the following label warning statement is now required on all listed medicines containing Andrographis paniculata: '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). Sponsors of existing listed medicines will need to ensure that medicines containing Andrographis paniculata that are released for supply from 2 May 2020 are compliant with the new requirements. Any new listed medicines need to comply with the new requirements immediately. Source: Allergy risk statement required

TGA Publishes Outcomes Regarding Changes to Low-Negligible Risk Permissible Ingredients

On 30 August 2019, the TGA sought comments on proposed changes to the following 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. All comments received for this consultation have now been considered and the proposals have now been published. These changes will commence on 2 March 2020. Source: Low risk ingredients (Please see also scheduling timetable for low-negligible risk changes for 2019-2020. Low risk ingredient schedule )

Changes to Propolis and Royal Jelly in Listed Medicine Applications – Free ARTG Entry Soon to End

The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Register of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry. Source: Honey & propolis ARTG

Aussie Company Fined for Falsely Claiming to Hold Evidence for Kids Eye Care Medicine

Caruso's Natural Health Pty Ltd has paid penalties of $12,600 in response to an infringement notice issued by the Therapeutic Goods Administration (TGA). The infringement notice was issued to the company for making a false or misleading certification that it held evidence to support some of the indications for the product Caruso’s Kids Eye Care. The TGA reminds all medicine sponsors that they are required to certify/confirm that they hold evidence for all the indications and claims made about their medicine. The TGA conducts post-market compliance reviews of listed medicines, with a proportion of these selected randomly using a computer algorithm. These reviews allow the TGA to determine whether listed medicines comply with relevant regulatory requirements, including the truthfulness and accuracy of the certifications a sponsor makes at the time of listing a medicine. Caruso's Kids Eye Care was randomly selected for a compliance review which involved an assessment of the evidence held by the sponsor to support the efficacy of the medicine. Source: Caruso's false claim

Multi-Level Marketing Company Fined for Advertising Breaches

The Juice Plus Company Australia Pty Ltd has paid penalties of $37,800 after the Therapeutic Goods Administration (TGA) issued three infringement notices for alleged advertising breaches relating to vitamin products. The TGA alleged the advertisements did not comply with the therapeutic goods advertising requirements, by promoting the products for a condition that is not permitted for this medicine, and by using

health professional endorsement of the products. Direct sellers of these products should be aware that they have the same legal obligations as the company when advertising therapeutic goods and must comply with the Therapeutic Goods Advertising Code. Source: MLM court fine

“Let Medicine Be Thy Medicine, and Food Be Thy Food” – Hippocrates 460-370 BCE

Just what constitutes a medicine and what is legally categorised as a food can be a tricky point of difference at times; especially at the medicine-food interface (think ‘sports food supplements’). Generally speaking, food is for nutrition, while medicine treats or prevents disease. Whether a product is food or medicine also has important implications for how it is regulated. In Australia, medicines are regulated at a Federal level while food regulation comes under the jurisdiction of the individual states and territories. Any product that is taken orally (eaten) can be classified as food, however, a food cannot be a medicine, and a medicine cannot be a food. A product is classified as a medicine if it is represented to be a therapeutic good, likely to be taken for therapeutic use, or declared to be a therapeutic good. In Australia, we do not have a separate regulatory category for ‘dietary supplements’. All supplements are either foods or medicines, depending on the supplement's individual features. We’ve come a long way since Hippocrates wrote nearly 2,500 years ago, so please remember that foods and medicines are fundamentally different, and you wouldn't expect one to do the job of the other. Then you'll be able to enjoy food at every meal and take medicine when you need it. Source: Food V Medicine

Government Grant Round Opens to Enhance Food Chain Traceability

The Department of Agriculture is inviting applications for grants to fund projects to enhance traceability in the food supply chain, enhancing trust in Australian-grown products and boosting the competitiveness of agricultural exporters. An initial $4 million round of Traceability Grants Program funding, opening from January 8, will be available to individuals, communities, government or private sector organisations, as well as agricultural export industries, to enhance traceability in supply chains. The program will provide opportunities for successful applicants to carry out projects that enhance product traceability and the competitiveness of Australian produce, for example by supporting assertions around organic or location-specific production. Source: Food traceability grants

Food Importers and Food Allergen Management

Importers of foods are reminded of the importance of understanding the supply chain for foods they import and any potential for allergen cross contact to inform risk management including appropriate allergen labelling. There have been several food recalls related to undeclared allergens, in Australia and internationally. Most recently, pesto and associated products were recalled because they contained an undeclared allergen (peanut). Peanut had contaminated one of the ingredients (processed cashew) used in these products. The recall included imported products and product manufactured in Australia from imported ingredients. Source: Food allergy contamination

ACCC Announces 2020 Compliance and Enforcement Priorities

The Australian Competition and Consumer Commission (ACCC) has outlined its priorities for 2020 and has stated that the growing community attention to health-related issues has led the ACCC to take a more active role in preventing deceptive conduct in the marketing of food products. “Misleading claims about health or nutritional benefits harm consumers as they often pay a higher price for products without receiving the benefits claimed,” said ACCC Chair, Rod Sims. Source: ACCC 2020 priorities

FSANZ Notifications—

Application A1155 – 2’-FL and LNnT in infant formula and other products: The purpose of the application is to permit the voluntary use of 2’-O-fucosyllactose (2’-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation using genetically modified Escherichia coli (E.coli) strains, in infant formula products and formulated supplementary foods for young children. Source: GM E. coli in FSFYC

Application A1171 – Endo-inulinase from GM Aspergillus oryzae as a Processing aid (Enzyme): The purpose of this Application is to permit the use of Endo-Inulinase produced from a GM modified strain of Aspergillus oryzae as a Processing aid. Source: GM aspergillus 1

Application A1176 – Enzymatic production of Steviol Glycosides: The purpose of this application is to seek approval for a new specification for steviol glycosides produced by an enzymatic conversion method using enzymes derived from genetically modified strains of Escherichia coli (E. coli). Source: GM E. coli

Application A1181 – Maximum residue limits for Imazapyr in Barley Grain: The purpose of this application is to increase the maximum residue limit for imazapyr in barley grain from 0.05ppm to 0.7ppm. Source: Barley MRL

Application A1184 – Glucoamylase from GM Aspergillus niger (donor Trametes cingulata): The purpose of the application is to approve the use of glucoamylase sourced from GM Aspergillus niger containing the gene from Trametes cingulata. Source: GM aspergillus 2

Application A1185 – Alpha-amylase from GM Aspergillus niger as a processing aid (enzyme): The purpose of this application is to approve the use of Alpha-amylasee sourced from Rhizomucor pusillus in GM Aspergillus niger. Source: Aspergillus enzyme

Proposal P1050 – Pregnancy warning labels on alcoholic beverages: This proposal seeks to revise the warning statement to read: “Alcohol can cause lifelong harm to your baby” from, “Any amount of alcohol can harm your baby”, and also to revise the specific colour printing requirements of that warning text. Source: Warning statement

RFA Provides Comprehensive Training in Regulatory Affairs

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website www.rfaregulatoryaffairs.com/training-courses . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from our Glebe, Sydney office, at your office or remotely via Skype. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it. to receive the latest information on our training courses.

PUBLIC NOTICE – Australian Bushfires - Update

Following on from last month’s note of RFA’s appreciation of support from our many readers, here and overseas, this is the latest news update regarding Australia’s long hot summer of bushfires. The good news is that over the last few weeks, much of Eastern Australia has received widespread soaking rains that have snuffed out the last of these dreadful bushfires. However, the drought persists in many places and will take more rain still before we can declare the drought to be properly ‘broken’. For now, the rebuilding can begin.

Thank you once again for all your interest and care shown to us through this difficult time.

Postscript: The loss of lives, including three American pilots; the massive loss of wildlife and habitat; and the severe impact on our communities after several months of bushfire has left us physically strained and emotionally frazzled. So, it was with much joy and gratitude that that we tuned in to the internationally supported Fire Fight Australia concert held recently in Sydney. Artists from around the world gave freely of their time and talent in order to entertain more than 75,000 people in the audience as well as millions more via media. 22 acts performed over 10 hours and raised more than $10 million for bushfire relief. Rock band Queen reprised the same set they played in the 1984 Live Aid concert! On behalf of all Australians, we would like to thank once again the many global citizens who have responded to our trials with such generous care and concern. It has been very much appreciated. Concert review

Reminder – Farewell NICNAS and Hello to AICIS

As regular readers of this newsletter will already know, the Australian Industrial Chemicals Introduction Scheme (AICIS) will replace NICNAS on 1 July 2020 as the new national regulator of the importation and manufacture of industrial chemicals in Australia. The ban on the use of new animal test data for ingredients solely used in cosmetics will also begin on 1 July 2020. As such, NICNAS is holding information sessions in capital cities to help stakeholders understand and comply with the new scheme. At this stage the Sydney and Melbourne information sessions are fully subscribed but new sessions may yet be arranged, and a Brisbane information session is being planned for April or May. Source: NICNAS session (Breaking news: New workshops now available: AICIS workshop dates )

TGA Database Publishes Listed Medicine Compliance Review Results

To monitor the safety, quality and efficacy of listed medicines and ensure they meet all requirements once they are on the market, the TGA conducts listed medicine compliance reviews on a proportion of those on the Australian Register of Therapeutic Goods (ARTG). This database makes information publicly available about the results of TGA's compliance reviews of individual listed medicines. Publication of results only occurs once the compliance review has been concluded, after the sponsor has had the opportunity to consider our findings and actions have been undertaken to address any identified issues and the results are released quarterly. Source: LM reviews (Please see also: Compliance Actions and Outcomes)

‘Health Products Regulation Group’ Details Regulatory Science Strategy for Next Five Years

The HPRG comprises the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC). Regulatory scientists in HPRG use highly developed knowledge and skills from a range of disciplines to make, or contribute to, risk-managed and evidence-based decisions about health products. This document outlines a strategy for how HPRG will maintain and build regulatory science capability over the next five years. It identifies ways to make sure that they continue to make the best possible decisions, and that they are prepared for future regulatory challenges. This will help meet the vision of better health and wellbeing for all Australians through regulatory excellence. Source: HPRG 5 year strategy

Increased Online Access to Ingredient Information Following TGA Response to Consultation

Throughout 2019, the TGA sought feedback from interested parties on a proposal to increase access to ingredient information. It was proposed to publish the names of excipient (or 'inactive') ingredients in the public view of therapeutic goods on the Australian Register for Therapeutic Goods (ARTG). All submissions and survey responses that were not marked as confidential are available here: TGA consultation responses

Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project

A Lower Risk OTC Products Review pilot project was developed in response to recommendation 14 of the Medicines and Medical Device Regulation Review (MMDR) where the TGA examined whether the regulations and restrictions in place for various ‘low risk’ registered therapeutic goods are still appropriate. This recommendation related to several different types of therapeutic goods, including registered OTC medicines. The TGA undertook to review classes of registered OTC medicines, that have a higher amount of regulation applied to them, to assess whether they may be suitable for becoming listed medicines (listed medicines have less strict regulatory guidelines applied to them). A pilot project was proposed to provide further clarity on the resource requirements, limitations and impacts on medicine sponsors as well as to address additional issues raised by industry during the consultation. 'Antimicrobial throat lozenges' were identified as the medicine group to be considered for the pilot project and the results may be read here: OTC pilot project

Consultation: Adoption of European Union guidelines in Australia

The TGA confers with other overseas regulators in order ensure, where possible, maximal regulatory conformity. Currently, the TGA is conducting a consultation to determine whether it will adopt a range of guidance systems used by the EU. In Australia, the listed medicine system is not monograph based, however the proposed guidance may be relevant to new substance applications, listed assessed medicines or registered medicines, as these application types may use EU monographs as supportive documentation. Consultation closes 7 February 2020. Source: EU guidelines consultation

Consultation: Proposed Amendments to the Poisons Standard

Substances which may be of interest include: Arbutin (α and β); Picramic acid (new item); and, marker dyes or pigments (new interpretation). This consultation closes on 10 February 2020. Source: SUSMP consultation