TGA Results Confirm Effectiveness After Sunscreen Testing

In response to reported concerns during the past Australian summer that sunscreens were failing to provide adequate sun protection, the TGA undertook laboratory testing of 31 commonly used products, including lotions, creams and aerosol sprays, sourced from pharmacies and supermarkets. Between 1 January and 31 December 2016 the TGA received a total of 27 reports of adverse reactions to sunscreens. Of these 15 were reports of allergic reactions (rash) and 12 reports of a product not being effective. It was found that all products tested contained the correct levels of ingredients, as specified on their labelling, and complied with the Australian regulatory guidelines for sunscreens for content of sun protection ingredients (90-120% of the labelled claim).    Source: Sunscreen testing

TGA Changes Policy on Vitamin A – Betacarotene Naming

For many years, it has been generally understood that early TGA advice indicated that suppliers could not refer to betacarotene as provitamin A or state the equivalent IU of Vit A. However, the TGA seems to have changed this policy, and now betacarotene may be stated in retinol equivalents. Furthermore, the NHMRC Nutrient Reference Values for Australia and New Zealand note that the term vitamin A includes provitamin A carotenoids that are dietary precursors of retinol and retains 6 µg all-trans ß-carotene as being equivalent to 1 RE (retinol equivalents). When Vitamin A is declared as an equivalent of Betacarotene and the medicine is for oral or sublingual use in adults the medicine also requires specific warning statements on the medicine label.    Refer: Vitamin A

TGA Form Update - Notification of a New Proprietary Ingredient

The role of the 'Notification of a new proprietary ingredient' form is to allow the TGA to enter formulation details and other relevant information relating to a proprietary ingredient into the Proprietary Ingredient Table in TGA Business Services. This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number for each proprietary ingredient. Applications for new therapeutic goods that are to be included on the Australian Register of Therapeutic Goods (ARTG) can then include these complex formulations in a single step using the allocated proprietary ingredient number (rather than the full formulation details of the proprietary ingredient).    Source: New ingredient

TGA Targets Macular Degeneration Claims

Macular degeneration is a restricted representation and not permitted in listed medicines. The TGA will examine the unauthorised reference of macular degeneration in listed medicines. If a supplier’s medicine is included in the targeted project, the TGA will write to you in July 2017 and request information such as your product label and the evidence you hold to support claims and indications. Be Prepared!   Source: Macular degeneration

TGA Q&A on the Code of Good Manufacturing Practice for Medicinal Products

Everything that you wanted to know about how and why the TGA regulates Good Manufacturing practice in Australia.    Source: GMP Q&A

Regulatory Battle: New Zealand Manufacturers Hit Out at Health Bill ‘Detractors’

Five major New Zealand manufacturers – backed by trade body Natural Products New Zealand (NPNZ) – have hit out at a "small group of detractors” which they claim is creating "misinformation" about the country's proposed Natural Health Products Bill.    Source: Gary Scattergood+, Nutraingredients-Asia NZ Health Bill

TGA Safety Advisories:   SourceAlerts

Dragon Power (Yong Gang Tablets) - the tablets contain the undeclared substance sildenafil.

Slimming Capsule - Reduce Fat - the capsules contain the undeclared substances sibutramine and phenolphthalein.

7-Days Herbal Slim-Extra capsules - the capsules contain the undeclared substance sibutramine.

RFA Breaking News

Training Course Update:

NEW COURSE NOW AVAILABLE Pharmacovigilance Obligations Training. For details see foot of this newsletter

Readmore..

Complementary Medicines (“Dietary supplements”):

  Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 Update. This far reaching bill has implications for those involved in the supply of Listed Medicines, or Medical Devices, as…

Readmore..

Foods:

  New NZ Government Pulls NHP Bill Regular readers of this newsletter will have noticed the tortuous path of the Natural Health Products bill as it slowly makes its way…

Readmore..

Cosmetics (& Household cleaning products):

  Correction of an Error on AICS The National Industrial Chemical Notification Scheme (NICNAS) has corrected a listing error on the Australian Inventory ofChemical Substances (AICS), after an entry that…

Readmore..

Marketing News:

The Seismic Shifts in Marketing’s Role in Direct Selling “Marketing doesn’t matter for a direct selling company.” Have you ever heard this one before? If you’ve been working in direct…

Readmore..

RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available

Are you new to the Australian market? Are you unsure about how to comply with recent changes to TGA regulations such as the new TGA Order 92? Do you have…

Readmore..

Go to top