TGA Releases Updated Australian Regulatory Guidelines For Complementary Medicines (ARGCM)

The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. As reported in recent issues of this newsletter, the TGA has undertaken the biggest review of regulations regarding the supply of CMs since its inception. This latest version, ARGCM Version 8, includes amendments to ARGCM Part C to incorporate legislative changes for new substance evaluations. Other parts of the ARGCM will be amended in 2018 to reflect other legislative changes arising from the Government's complementary medicines reforms. This newsletter will keep you informed as more information comes to hand.   Source: ARGCM version 8

TGA Details Upcoming Changes To The Permissible Ingredients Determination

All ingredients available for use in listed medicines in Australia and any restrictions pertaining to them are listed in the Therapeutic Goods (Permissible Ingredients) Determination. The Determination is continually reviewed by the TGA to ensure that all ingredients are safe for use in low-risk medicines. It is updated quarterly through the addition or removal of ingredients, and the clarification, removal or addition of restrictions or warning statements. This document outlines changes that have been made to the Determination in the first half of 2018 and the upcoming changes for June. As well as there being a new herbal naming standard for new herbal ingredients and addition of 4 new ingredients, other changes include removal of 2 previously permissible ingredients and removal of several required warning statements. Of particular interest is the ‘correction of restrictions relating to coumarin’. (The requirements for coumarin in a number of herbal ingredients have been amended to correctly align with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) in referring to concentration, rather than maximum daily dose). 11 ingredients are affected by this change. By June 2018 there will be further changes affecting the therapeutic role of menthol, herbal name changes, and the addition of 4 new ingredients. Of special note is clarification of ‘SUSMP requirements for arbutin’. (Ingredients known to contain arbutin will have arbutin listed as a mandatory component with associated specifications in line with the Poisons Standard. There are 11 affected ingredients). Finally, there are also ‘new restrictions on poliglusam’ and ‘new restrictions on methyl salicylate’ with 9 ingredients affected, and ‘new restrictions on cysteine’. Changes regarding ‘curcuminoids’ and caffeine restrictions have been delayed for further review.   Source: Permissible ingredients

TGA Proclaims Changes to Evaluation of Substances for Use in Listed Complementary Medicines

The process for evaluation of substances for use in listed complementary medicines has changed. The TGA has introduced new application categories and legislated timeframes for evaluation of substances for use in listed complementary medicines. There is also a new mechanism to permit a successful applicant of a new complementary medicine substance to have exclusive use of that ingredient for a specified period of time. Implementation of this reform aims to support innovation and improve the evidence base for complementary medicines.   Source: LM substance evaluation

TGA Publishes Outcomes of the Consultation on the Draft List of Permitted Indications

On 6 March 2018, the TGA implemented a list of permitted indications for medicines. Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. Sponsors can still apply to have new indications considered for inclusion in the Permissible Indication Determination. A full outcome summary can be read at this site.   Source: Permitted indications

TGA Consultation: Advertising Therapeutic Goods To The Public

The TGA is seeking comments from interested parties and the views of stakeholders on the proposed advertising complaints handling model. As the single agency for therapeutic goods advertising complaints management from 1 July 2018, the TGA is undertaking this public consultation to seek stakeholder's views on its proposed complaints handling model. The public consultation paper outlines the proposed model of advertising complaints handling which aligns with best practice models of complaints handling by comparative Commonwealth regulators. This complaint handling model is intended to ensure that non-compliance remedies are appropriate, proportionate, timely and consistent with contemporary practice. This consultation closes on 4 June 2018.   Source: TGA product complaints

TGA Seeks Input: Options for the Implementation of a Claimer for Efficacy of Assessed Non-Prescription Medicines

The TGA is seeking comments from interested parties on the use of a claimer for efficacy assessed non-prescription medicines. In the February 2017 consultation paper, ‘Reforms to the framework for complementary medicines: Assessment Pathway’, the TGA consulted on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. This was supported by the majority of respondents. Now, further feedback is requested, specifically related to the types of medicines that should be allowed to carry a claimer; options to implement the claimer as a visual identifier and/or label statement; and, how the claimer can be used on medicine labels. TGA will also conduct consumer focus group testing on the options presented in this paper to confirm whether the potential options will achieve the objectives of the recommendation.   Source: Claimer consultation

TGA Concerned Claims About Hemp and CBD Oils Are Misleading Consumers

The Therapeutic Goods Administration is aware of false and misleading claims being made by some companies supplying products containing cannabidiol (CBD). Companies located in the United States have been illegally exporting cannabidiol (CBD) and hemp products to persons in Australia without import permission. The TGA is aware of at least one company who has claimed that the TGA has invited them to register their CBD and hemp products on the Australian Register of Therapeutic Goods (ARTG) due to growing demand. This is incorrect. The TGA does not 'invite' businesses or sponsors to register a product on the ARTG. The onus is on the sponsor to apply to the TGA and follow due process. The importation of these products is illegal unless the importer holds a licence and permit to import from the Office of Drug Control (ODC). Imports of these goods that do not have the relevant import permissions will be seized at the border. Individuals and businesses in Australia importing CBD/hemp oils are also breaking State/Territory laws on supply and use of prescription medicines.   Source: Cannabis claims

‘TGA Proposal To Change The Medicine GMP Fees And Charges’: Submissions Summary

The TGA has published the combined submissions from respondents to the February 2018 public consultation paper, ‘Consultation: Proposal to change the current Good Manufacturing Practice (GMP) fees and charges’. Consultation closed on 5 March 2018 and a total of 31 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format.   Source: GMP charges responses

Important Dates for TGA Compliance

22nd July 2018 - Annual Charge Exemption (ACE) declarations will be available from 1 July 2018. The deadline to provide declarations in relation to your entries (whether active or cancelled) that had an ACE in 2017-18, must be submitted between 1 July and 22 July 2018. A declaration of $0 turnover has the effect of confirming the 2017-18 exemption, and ensuring the entry will continue to be ACE in 2018-19;     Early August 2018 - Annual charge invoices issued for 2017-18 (unless exempt) and for 2018-19; 15 September 2018 - Deadline to pay annual charges.

TGA Safety Advisories—

SLIM BODY Advanced capsules - The Therapeutic Goods Administration (TGA) has tested a product labelled SLIM BODY Advanced capsules and found that the capsules contain the undeclared substance sibutramine.   Source: Slim body caps

Lishou Strong Slimming capsules - contain the undeclared substance sibutramine.   Source:  Lishou caps

JAGUAR 30000 capsules -contain the undeclared substance tadalafil.   Source: Jaguar caps

Medsafe NZ Warns That Turmeric / Curcumin Containing Products Can Interact With Warfarin

The Centre for Adverse Reaction Monitoring (CARM) recently received a case report describing a patient taking warfarin who began taking a turmeric containing product. The patient had stable INR measurements, but within a few weeks of commencing turmeric their INR increased to over 10. There is a risk of serious bleeding when the INR gets this high. The reporter considered that the turmeric containing product had interacted with warfarin.   Source: Turmeric safety

Traditional Vs ‘Modern’ Medicine Debate Continues

As reported in our February 2018 newlsetter , as part of the TGA Complementary Medicines Reforms, regarding ‘Permitted Indications’ , there is scope to also include ‘Traditional Indications’. This has raised the ire of many who view scientific modern medicine as the only authority as to what makes humans sick and what can therefore make humans healthy. Chair of the RACGP Expert Committee – Quality Care, Dr Evan Ackermann, is quoted as saying, “The 860 claims that will be legally permitted on complementary medicine under this new legislation have no scientific basis and can cause harm”. This is inspite of the guidelines for traditional medicines being in line with World Health Organisation guidelines on the role of complementary medicines. The proposed legislative changes are intended to make it easier for consumers to differentiate between traditional or complementary 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. Culture clash?   Sources: Megan Haddan, AJP Doctor's disquiet &, TGA evidence


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