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

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