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TGA Presentation: How Do Listed Medicines Shape Up In The Post-Market Compliance Space?

Dr Allison Jones presented this discussion at the recently held ARCS Scientific Congress held in Canberra. This presentation provides an overview of the TGA's post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.   Sources: TGA compliance; PDF

TGA Publishes New Permissible Ingredients Determination

The Therapeutic Goods Administration has recently published the new Ingredients Determination 2 of 2016.  This document includes 205 amendments to ingredients for use in Listed complementary medicines. In summary, 38 new ingredients have been added to the list; 164 ingredients currently contained in the Determination have been amended; 3 ingredients have been removed from the list; and, the Determination also removes the active and excipient purposes for the ingredient Sanguinaria Canadensis.   Source: Permissible ingredients

TGA Provides Guidance for New Registered Complementary Medicine Applications

The Therapeutic Goods Administration has issued the latest guidance for registered complementary medicine applications, and explains the new online application form on the TGA Business Services website.   Source: Registered CMs

TGA Consultation: Proposed Amendments to the Poisons Standard

The Therapeutic Goods Administration is seeking comments from interested parties on proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Medicines Scheduling (ACMS). Interested parties should respond by close of business 1 September 2016.   Source: TGA ACMS consultation

TGA Update on Medical Devices

This information is intended for current users of ISO 13485:2003 who are considering transitioning to ISO 13485:2016, and other interested parties. In March 2016 the International Organization for Standardization (ISO) published a new revision to ISO 13485, the medical device quality management systems (QMS) standard for regulatory purposes, which replaces the previous version from 2003. Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing for users of the standard to transition to the new revision of the standard.   Source: TGA Medical Devices

TGA Amends Sponsor Requirements

Amendments made to the 'sponsorship transfer' and 'changes in sponsor name' provisions in the Therapeutic Goods Regulation 1990 (the Regulations) commenced on 17 August 2016. As a result, there will be more consistent arrangements across the 3 different kinds of therapeutic goods (i.e. listed and registered goods, medical devices and biologicals).   Source: TGA Sponsors

TGA Aims to Make Australian Medicine Labels Clearer

The Therapeutic Goods Administration is changing medicine labels to make important information about medicines easier to find. These new requirements to make Australian medicine labels clearer and more consistent will be introduced from 31 August 2016. A four year-transition period applies.  Sources: Medicine labels; Label guidance; TGO N0.92

TGA Updates List of 'Permissible Ingredients' for Use in Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) on 1 August 2016. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016.   Sources: TGA PI Update; Affected ingredients; Compositional guidelines

TGA Updates MRA GMP Clearance Application Processing Times

As of 31 July 2016, the average processing time taken to complete an MRA GMP clearance application was 4.8 weeks. The time taken to complete 90% of MRA GMP Clearance applications was 7.8 weeks. For a comparison with earlier reported timelines since May 2015 go to: GMP timelines

TGA Safety Advisories:

Mi Show Slimming capsules:  The Therapeutic Goods Administration has tested this product and found that the capsules contain the undeclared substance sibutramine. (Sibutramine was withdrawn from world markets in 2010 due to an increased risk of cardiac events and stroke).   Source: Slimming capsules; Buyer beware!

NSW Food Authority Recalls:

Health Lab Protein Balls. Health Lab has recalled its Energise Choc Protein Balls and Refresh Choc Mint Protein Balls due to the presence of an undeclared allergen (cashew nut).   Source: Protein Balls

IKEA CHOKLAD and GODIS products - dark chocolate. IKEA Pty Limited & Cebas Pty Ltd has recalled CHOKLAD and GODIS chocolate products from IKEA stores due to the presence of undeclared allergens (milk, hazelnuts and almonds).   Source: IKEA chocolate

Sweet William Dairy Free Chocolate. Sweet William Pty Ltd has recalled Sweet William Dairy Free Chocolate Original due to the presence of an undeclared allergen (dairy).   Source:Sweet William

Zehnder Gluten Free Breads. The New South Wales Food Authority advises that Gluten Free Bakehouse Pty Ltd has recalled multiple Zehnder Gluten Free breads due to the presence of an undeclared allergen (soy).   Source: Zehnder breads

Salmonella Linked to NT Rockmelon Grower

South Australian health authorities have detected Salmonella on rockmelons supplied by a Northern Territory rockmelon grower. The link comes after a spike in Salmonella Hvittingfoss cases, a rare strain of Salmonella, across a number of states in the past weeks, with 86 cases reported nationally, 43 of them in NSW.   Source: Rockmelon

FSANZ Notifications:

Application A1134– Phytosterols in Portion-controlled Breakfast Cereals.   The purpose of the Application is to amend current novel food permissions for phytosterols added to breakfast cereals to allow increased concentrations for portion controlled breakfast cereals, in either individually wrapped portions or portions that can be easily divided.   Source:FSANZ cereals

Proposal P1042 – Low THC Hemp Seeds as Food.   The purpose of this Proposal is to permit the addition to food of products from the seeds of low tetrahydrocannabinol varieties of Cannabis sativa.   Source: FSANZ hemp

Application A1128 – Food derived from reduced Acrylamide Potential & Browning Potato Line E12.   The purpose of the Application is to seek approval for food derived from a genetically modified potato line, E12 which has reduced acrylamide potential and reduced browning (black spot).   Source: FSANZ potatoes

Fourth Time Lucky? Aus-NZ Officials Consider Hemp's Safety Once Again

Australia’s food safety regulators have once again called for submissions on whether to permit the sale of food derived from the seeds of low-THC hemp.   Source: RJ Whitehead, Food Navigator-Asia  hemp seeds

NZ Natural Health Industry Seen as Second Best to the Aussies

The Aussies are beating Kiwi natural health exporters in capturing big overseas contracts because of delays in passing the Natural Health and Supplementary Products Bill, an industry body says. Natural Products New Zealand, a group that represents about 80 per cent of the country's producers of vitamin pills, oil capsules, herbal teas and natural creams and gels, says New Zealand has been falling behind other exporters, with Australian companies gaining an edge in high-growth markets. The bill, which has been more than 10 years in the making and still going through the legislative process, aims to regulate natural health and supplementary products.   Source: Stuff.co.nz NZ Health Bill

FDA Releases Revised Draft of NDI Guidance

The Food and Drug Administration (FDA) today released revised draft guidance for new dietary ingredients (NDIs) to be published in the Federal Register on Friday.  The revised draft replaces FDA's 2011 draft.   Source: FDA Ingredients

EFSA Rejects Fish Oil Memory Claim

The European Food Safety Authority (EFSA) has thrown out a health claim for a ‘DHA-enriched fish oil’ and the reduction of age-related cognitive decline.   Source: A-R Harrison-Dunn, Nutra Ingredients.com  DHA claims

What You Probably Didn't Know About Food Colouring - Some colours are actually made from insects.

Food colouring is used to add colour to foods to make them more attractive and eye-catching, and they can also be added to medications. While some of the colours are derived from natural products, others are made synthetically. Chemically produced food colouring is often derived from petroleum, a crude oil product. Natural food colouring is derived from plant and animal pigments. All colours added to foods in Australia, like any other food additives, are regulated by Food Standards Australia New Zealand.   Source: Juliette Steen, HuffPost Aust. Food colouring

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Marketing News:

Innovation: Study used chia and flaxseeds to encapsulate probiotics

By spray drying, researchers from Chile and Canada encapsulated Lactobacillus plantarum and Bifidobacterium infantis using chia and flaxseed.   Source: Adi Menayang, Nutra Ingredients-USA Probiotic encapsulation

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