Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
This issue of RFA Newsletter is sponsored by:
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Complementary Medicines (“Dietary supplements”):
BREAKING NEWS! Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 Update
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. These are the most significant changes to the legislation affecting complementary medicines in Australia since the Therapeutic Goods Act was first introduced. The Bill establishes a new ‘intermediate’ pathway for ‘complementary medicines sitting between Aust-Listed and Aust-Registered, and introduces improvements in the way new substances are processed. In next month’s newsletter we will include a detailed and comprehensive summary of the changes and how they might affect you. Source: Legislation passed
TGA Complementary Medicines Reforms – Permitted Indications, Including Traditional Indications
The reforms are designed to give greater certainty and protection for consumers regarding traditional medicines, such as Chinese and Indigenous medicines. The guidelines for traditional medicines are in line with World Health Organisation guidelines on the role of complementary medicines. This will make it easier for consumers to differentiate between traditional orcomplementary medicines which have had scientific evidence assessed and those that have not. Once the new system is in place any companies which make claims that are found not to have the evidence to support their statements, will have their products removed from the Australian Register of Therapeutic Goods unless corrective action is taken. Source: TGA evidence
TGA Pharmacovigilance Inspection Program Risk Assessment Survey
The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete. The survey will remain open until 31st March 2018. Medicine sponsors that do not complete the TGA Pharmacovigilance Inspection Program Risk Assessment Survey before 31 March 2018 will be given the highest risk score and prioritised for inspection. Source: Pharmacovigilance survey Editor’s note: Please see newly created RFA training course on pharmacovigilance – details at foot of this newsletter.
TGA Flags Changes to the Permissible Ingredients Determination
All ingredients available for use in listed medicines and any restrictions pertaining to them are listed in the Therapeutic Goods (Permissible Ingredients) Determination. Of special interest is the recent addition of 4 new ingredients; and in addition, the new ingredient name “curcuminoids” (for turmeric extracts) should be noted by many complementary medicine suppliers in Australia. Changes that will be made in the first half of 2018 include: herbal naming standard for new herbal ingredients; and removal of some ingredients; and other measures. Source: Permissible ingredients
TGA Guidance on Types of Ingredients in Listed and Registered Complementary Medicines
In this statement, the TGA attempts to specify such items as: active ingredients in complementary medicines; excipient ingredients; colourings permitted; “incidental minor excipients”; proprietary ingredients; labelling associated with proprietary ingredients; GMP requirements for proprietary ingredients; active herbal extracts; amino acid chelates; ingredients in listed CMs; Australian native and endangered species in CMs; and genetically modified substances. Source: CM ingredient types
TGA Proposes Changes to the Current Good Manufacturing Practice (GMP) Fees and Charges
The Therapeutics Goods Administration operates on a fully cost-recovery basis. The TGA engaged Deloitte to undertake a review of its current Good Manufacturing Practice (GMP) fees and charges for medicines and Active Pharmaceutical Ingredients (APIs). The purpose of the review was to improve the accuracy and transparency of the cost recovery arrangements for that regulatory function and address a significant under-recovery over the past four financial years. Deloitte has also examined the fees and charges levied by the TGA's international counterparts for comparable functions. The selection of one option as preferred has been made by Deloitte on the grounds that this option encourages a higher level of compliance by manufacturers and sponsors in order to reduce regulatory fees and charges and addresses all major areas of under recovery. Source: GMP cost recovery. Please see also: Information sessions: Proposal to change GMP fees and charges
The Poisons Standard (the SUSMP) Update
The Poisons Standard February 2018 is the current edition, this supersedes the Poisons Standard October 2017. The current Poisons Standard incorporates numerous changes to the Poisons Standard October 2017. Source: SUSMP 2018
TGA insists that GPs Will Still be Able to Prescribe High-Dose Opioids
The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids. As part of the discussion paper the TGA has issued on the use and misuse of opioids, there is an option about the level of training for potentially dangerous drugs which is being discussed in consultation with the AMA, the RACGP and other appropriate bodies. Source: Prescribing opioids
CMA Publishes Advocacy Booklet, “The Science of Complementary Medicines”
Complementary Medicines Australia (CMA) is the peak industry body for the complementary medicines industry in this country. This handy booklet summarises the use of CMs in Australia and looks at traditional and scientific evidence behind their use. Source: CMA advocacy
AHPA Publishes Botanical Safety Handbook Promoting Safe Use of Herbal Supplements
To help ensure the safe use of herbal supplements and prevent drug interactions, the American Herbal Products Association (AHPA) produced the Botanical Safety Handbook to summarise the latest research on the safety of more than 500 species of herbs. Source: Botanical safety handbook
Medsafe Early Warning on Wormwood Product
New Zealand Medicines & Medical Devices Safety Authority (Medsafe), warns of potential risk of harm to the liver for users of the product ‘Arthrem’. Arthrem is marketed as a natural dietary supplement in New Zealand for maintaining and supporting joint health and mobility. (It is also marketed as a complementary medicine in Australia with the claim “May help to reduce osteoarthritis symptoms of joint pain and stiffness and to improve physical function of the joints”) Arthrem soft gel capsules contain 150 mg of concentrated Artemisia annua extract in grape seed oil. The Centre for Adverse Reactions Monitoring (CARM) has received 14 reports of liver toxicity associated with the use of Arthrem. To date all the reports of harm to the liver have involved patients taking Arthrem specifically. Since the chemical composition of the Artemisia annua extract is not disclosed it is not clear if other products containing Artemisia annua extract have similar effects. Source: Arthrem artemesia
Cosmetics (& Household cleaning products):
NICNAS Public Consultation Forecast
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the use of all chemicals within Australia, as well as helps protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use. All current and planned public consultations on the implementation of NICNAS reforms (listed as reforms), as well as existing risk assessment and regulatory processes (listed as non-reforms), can be found here: NICNAS consultation timelines
Accord Australasia Dispels Personal Care Myths
Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic and specialty products, their raw materials suppliers and service providers. In seeking to clarify misconceptions regarding cosmetics, personal care & household products, they have set up a website www.Furphies.org.au and ask such questions as: Is there lead in lipstick? Do sunscreens pose a health risk? And what does 'chemical free' or 'natural' really mean? Find the answers to these questions and much more at: Furphies
Quote for the month:
“As a start-up CEO I slept like a baby. I woke up every two hours and cried” Ben Harowitz (Co-founder, Opsware)
RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney
Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.
Forum Reviews Fast Food Menu Labelling Schemes
The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) is conducting a review of fast food menu labelling schemes in Australia. The review is considering the effectiveness of the fast food menu labelling schemes including implementation and emerging issues since the release of the endorsed National Principles for Introducing Point-of-Sale Nutrition Information in Standard Food Outlets in 2011. Source: Fast-food labelling
Food Derived Using New Breeding Techniques Up for Review
New breeding techniques (NBTs) refer to a variety of new approaches in plant and animal breeding that were not in use when Standard 1.5.2 ‒ Food produced using gene technology ‒ was first developed nearly 20 years ago. FSANZ is reviewing how the Food Standards Code applies to food derived using new breeding techniques. The review is expected to be completed by mid-2018. Source: Breeding technologies
Application A1144 – Re-categorising Coconut Milk for Food Additive Permissions. The purpose of the Application is to consider whether the food category for food additive permissions for coconut milk products is more appropriate under fruits, rather than beverages.
Application A1153 – Endo xylanase from T. reesei as a Processing Aid. The purpose of the Application is to include a genetically modified strain of Trichoderma reesei as a permitted source for Endo-1,4 (3) - ß -xylanase (E.C.126.96.36.199)
Application A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40. The purpose of this Application is to seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed.
Application A1157 – Enzymatic production of Rebaudioside M. The purpose of this Application is to seek approval for a new specification for rebaudioside M produced by an enzymatic biosynthesis method.
Application A1158 – Rosemary extract as a food additive. The purpose of this Application is to seek approval to permit the use of rosemary extract as a food additive (antioxidant).
Application A1159 – Triacylglycerol lipase from Trichoderma reesai as a processing aid (enzyme). The purpose of this Application is to permit the enzyme lipase, triacylglycerol from Trichoderma reesei as a processing aid for the production of bakery products and cereal-based beverages.
Application A1160 – Aspergillopepsin I from Trichoderma reesei as a processing aid (enzyme). The purpose of this Application is to seek approval to permit the enzyme Aspergillopepsin I from Trichoderma reesai as a processing aid for the production of potable alcohol products and proteinprocessing.
Pharmacovigilance Obligations Training - COURSE AVAILABLE
In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST L) included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report. All required documents including SOPs and reporting templates will be provided for your future use. This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance. This is all included in the price.
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