TGA Warns Against Use of Performance and Image Enhancing Drugs

Performance and image enhancing drugs are a diverse group of drugs that some people use with the aim of improving their sporting performance or pursuing a desired look for their body. These may include anabolic steroids, SARMS, beta-2-agonists, stimulants, peptides and even tanning agents. There is concern about both the known and unknown health risks when taking these drugs as well as the illegality of possession and use. The TGA recommends not to buy from overseas websites and to look for an AUST number on the label, which confirms it is a TGA regulated product.   Source: Performance drugs

(Related story: Shayna Jack and the Dilemma of Contaminated Sports SupplementsSource: Triple J Hack Supplement contamination ; & CMA Media Release)

TGA Signals Upcoming Changes to the Permissible Indications Determination

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit. Indications available for use for listed medicines are now contained in a 'list of permitted indications'. The proposed changes include the addition of 4 new indications, and changes to 32 existing indications to clarify/correct the wording of indications and/or indication requirements.   Source: Permissible indications update

TGA Discusses the Use of ‘Natural’ Claims When Advertising Medicines and Medical Devices

Following on from the previous guidance issued by the TGA (as reported in this newsletter’s June 2019 edition), more detail is provided here. The two main principles involved when deciding on the appropriateness of using the term ‘natural’ in advertising are - advertisers of medicines and medical devices must ensure that they do not mislead consumers when making natural claims, and advertisers must hold evidence that substantiates any claims, and provide this evidence to the TGA if asked.   Source: 'Natural' claims    (See also: Understanding what ‘natural’ means on your medicine)    

TGA Updates Advertising Code for Therapeutic Goods

Minor corrections and clarifications have been made to the Therapeutic Goods Advertising Code (No.2) 2018. These came into effect on 30 July 2019. Some of the changes made concern – clarifying the definition of ‘health warnings’, the use of ‘mandatory statements’, more flexibility in wording of ‘indications’, proper use of ‘health warnings’, and, required advice if pregnant.   Source: Therapeutic advertising

All That You Ever Wanted to Know About the Poisons Standard

The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) which promotes the uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia. This handbook provides guidance for stakeholders on how the Poisons Standard is amended and provides details of the processes that underpin the scheduling policy.   Source: Know your poison

TGA Safety Advisories- Source: TGA current year alerts

Hong Kong Tianli Biological – power tablet: Contains the undeclared substance Sildenafil

Bali Mojo capsules: Contains the undeclared substance Tadalafil

GMP Clearance Applications Using Health Canada Evidence Attract Special Charge

Australia’s TGA has Mutual Recognition Agreements with many countries, including Canada, concerning Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification. This means that Australian sponsors using manufacturers in Canada have been permitted to use the HC “Inspection Exit Notice” as evidence to demonstrate compliance in place of a GMP Clearance Certificate. However, this MRA is only applicable to inspections of Canadian manufacturing sites. When HC inspect outside their borders, there is insufficient evidence in these reports to demonstrate complete compliance. The TGA now charges an additional liaison fee to cover the extra work involved in processing CV clearance applications submitted using HC 'exit notices'.   Source: Health Canada GMP   (See also: TGA fees & charges )

Botanical Adulterants Prevention Program Wins Editors Award for Industry Initiative of the Year

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) received the Editor’s Award for “Industry Initiative of the Year” by NutraIngredients-USA, one of the leading natural products and dietary supplement industry trade publications in the United States. BAPP is an exemplary educational resource about adulteration in the botanical supply chain, with its growing body of peer-reviewed literature, laboratory guidance documents, bulletins, and newsletters.   Source: BAPP wins award ;   (See also: BAPP homepage )

RFA Congratulates Michael McGuffin on Celebrating 20 Years as AHPA President

RFA Regulatory Affairs has been a keen supporter of the American Herbal Products Association for many years. As Michael McGuffin celebrates his 20 years of presidency (“I’m 68 years old and I can only do this another 10 or 20 years”), now is a good time to look back on all the success of AHPA during Michael’s tenure – which can be neatly summed up with, “(the role of NHPA is) to promote the responsible commerce of herbal products.”   Source: M. McGuffin turns 20


our Sydney office:

Robert Forbes - Director
+61 2 9660 8027

Ellie Kim - Regulatory Affairs Manager
+61 450 533 129

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