Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary medicines ('Dietary supplements')
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
Soft Drinks and Junk Foods Forced to Ditch 'Misleading' Energy Labels
Soft drink and junk food manufacturers will be forced to remove "misleading" energy icons from labels, in a move welcomed by public health advocates as a step forward in fighting Australia's obesity epidemic. A majority of state and federal ministers agreed the energy icon displayed on confectionery products and sugary drinks instead of the health star rating was "making it difficult for consumers to compare like products" and its use should be discontinued. Manufacturers will have two years to remove energy icons from their products. Source: Dana McCauley, SMH Energy icon dropped
FSANZ Review of Food Derived Using New Breeding Techniques
Food Standards Australia and New Zealand is reviewing the Food Standards Code as it applies to food derived using new breeding techniques (NBTs). A consultation paper was issued in February 2018. The final report was released in December 2019 with three recommendations: to revise and modernise the definitions in the Code; to ensure that NBT foods are regulated in a manner that is commensurate with the risk they pose; and, to ensure there is open communication and active engagement with all interested parties and also explore ways to raise awareness about GM and NBT foods. Source: GM & NBT food review
Food Allergen Portal
Food allergies can be life threatening. For people who have a food allergy the only way to manage the allergy is to avoid the food allergen. For these reasons there are laws in place, for example mandatory labelling to help people who have a food allergy avoid food allergens. This food allergen portal was created by the Allergen Collaboration to provide different sectors in the community with links to best practice food allergen resources and key messages to promote in the different sectors. Source: Food allergen portal
Food Recalls – Is Your Business Prepared?
If you’re a food business, you should have a written plan in place to manage a potential product recall. It’s a legal requirement and the responsibility of all food businesses to ensure their recall plan is up to date. The start of the year is the perfect time to review and update your plan. Remember - it should cover the procedures, records and staff responsibilities that are in place for a food recall. A Food Recall Template is available at Food recall
End of 2019 Failing Food Reports
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the months of November and December. Among the usual pathogenic organisms detected in these imported foods are such organisms as Salmonella, Listeria, and E. coli and assorted toxins such as histamine, aflatoxin and others. Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals as well as a formulated supplementary sports food that contains synephrine. Source: November 2019 food fails ; December 2019 food fails
FSANZ Calls for Comment on Soy Leghemoglobin Permission
Food Standards Australia New Zealand (FSANZ) is calling for comment on an application by Impossible Foods Inc. to permit soy leghemoglobin in meat analogue products that is produced using a genetically modified strain of yeast. Soy leghemoglobin is a protein naturally present in the roots of soybean plants that is not currently consumed in the diets of Australians and New Zealanders. The applicant uses an original method of production where the genetically modified yeast is fermented to express soy leghemoglobin. Source: GM soy protein
Proposal P1044 – Plain English Allergen Labelling: The purpose of this proposal is to make allergen labelling requirements clearer and more consistent, to help food allergen-sensitive consumers and food businesses. Source: Allergen labelling
Proposal P1054 – Pure and highly concentrated caffeine products: This urgent Proposal was prepared to amend the Australia New Zealand Food Standards Code to prohibit the retail sale of pure and highly concentrated caffeine food products. Source: Caffeine ban
Application A1193 – Irradiation as a phytosanitary measure in food: The purpose of the Application is to extend the option of phytosanitary irradiation to all types of fresh fruits and vegetables. Source: Food irradiation
Application A1194 – Glucoamylase from GM Trichoderma reesei as PA (Enzyme): The purpose of the Application is to permit the use of glucoamylase sourced from GM Trichoderma reesei as a processing aid. Source: GM enzyme
Application A1195 – Alpha-amylase as a processing aid (enzyme): The purpose of the application is to permit the use of Alpha-amylase as a processing aid in brewed beverages and potable alcohol production. Source: Brewing enzyme
Application A1199 – Food derived from Innate potato lines V11 & Z6: The purpose of this Application is to seek approval for food derived from genetically modified potato lines V11 & Z6, which have lower reducing sugars, low acrylamide potential, reduced browning (black spot) and late blight protection. Source: GM spuds
Odd Spot: Dead Monkey in NZ Shipping Container
A dead monkey in a shipping container saw biosecurity officers swing into action in Whāngārei, New Zealand. A staff member at BBS Timbers found the dehydrated monkey body squeezed between sawn timber packs upon opening the container. The fumigated container had arrived from Guyana. The facility quickly alerted Biosecurity New Zealand, which advised how to remove the monkey. A biosecurity officer followed up with an inspection and picked up the body for disposal. "The whole response worked extremely well. We were contacted by the business very early and our officers quickly jumped into gear," says Biosecurity New Zealand spokesperson Stu Rawnsley. Source: Hey, hey, it's a monkey!
Training: RFA Provides Comprehensive Training in Regulatory Affairs
PUBLIC NOTICE – Australian Bushfires
RFA Regulatory Affairs would like to thank all our readers, colleagues and concerned friends for their many levels of support that they have conveyed to us over recent summer months. We much appreciate it.
As you may know, record-breaking temperatures and years of severe drought have fuelled a series of massive bushfires across south-east Australia. Although recent cooler conditions and rain have brought some respite, more than 60 fires are still burning in the states of New South Wales, Victoria and South Australia. Hot and windy conditions are forecast to return to many parts of New South Wales this week. Some 30 people have so far been killed - including four firefighters - and more than 10 million hectares (100,000 sq km or 24.7 million acres) of bush, forest and parks across Australia has burned.
This long hot summer is far from over. While our Sydney office is in no danger, it seems that all our staff know someone personally affected by this environmental disaster. Thank you all for your patience, thoughts and best wishes in these difficult times.
Cosmetics and TGA Listed Sunscreens
Sunscreen Chemicals Found in Blood Plasma
The results of a study by the US Food and Drug Administration (FDA) were released recently and confirmed concerns raised in a study last year by the same researcher (JAMA sunscreen study ). The trial used 48 volunteers to assess the absorption of six ingredients - avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate - in four sunscreen products, lotions and sprays. All six chemicals administered were absorbed and had blood concentrations so high the FDA decided further safety studies were required to determine the effect of exposure to these ingredients. Australian industry body Accord Australasia commented that the FDA study is part of ongoing work being undertaken by the US regulator and the Therapeutic Goods Administration is aware of these studies. Additionally, Accord notes that the study used elevated dosing regimes, which do not reflect the normal use of sunscreens by consumers. Source: Toby Crockford, Brisbane Times Sunscreen study . (Please see also Personal Care Products Council response to this reported study: PCPC study response )
Pristine Pacific Paradise the First Country to Ban Alleged Reef-Bleaching Sunscreen
Pacific holiday spot Palau has taken a radical step towards protecting its marine life by banning sunscreen chemicals linked to concerns about potential coral bleaching. From 1 January 2020, sunscreen that includes ingredients like oxybenzone and octinoxate is no longer allowed to be worn or sold. The compounds are commonly used in sunscreen formulas as they absorb ultraviolet-A rays. It isn’t the only nation leading the way, with Hawaii revealing in 2018 it was also legislating a ban against sunscreen that contained the alleged toxic chemicals. That law comes into effect from January 1, 2021. Source: Emilia Mazza, News.com.au Sunscreen ban (The Australian Industry body Accord Australasia response says that Australian regulators and a number of prominent Queensland reef scientists remain unconvinced by the evidence supporting these overseas bans. Accord cites the following article by Prof Terry Hughes in The Conversation as a balanced, independent view on the science behind the real-world challenges to the Great Barrier Reef - Accord response )
Complementary medicines ('Dietary supplements')
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