TGA Fact Sheet: Folate and Folic Acid for Use in Listed Medicines

This factsheet has been created for sponsors who wish to list folate products on the ARTG. It is intended to provide general information on the most commonly used folates and answer the most frequently asked questions. Folate, or vitamin B9, is an essential vitamin required by the human body for normal growth and development as it plays a critical role in the synthesis of DNA and RNA, and in the metabolism of certain amino acids. The term "folate" is actually a generic name for a group of related compounds with similar nutritional properties. The three most commonly used forms are folic acid, calcium folinate and levomefolate salts. All three forms can be incorporated into the body's metabolic pathways and may provide sources of the same biologically active form of folate – a compound known as 5-methyltetrahydrofolate (5-MTHF) or levomefolic acid.   Source: Folate

TGA Approves Permissible Ingredients (26BB) Determination No.1 of 2017

Complementary Medicines Australia advises that The Therapeutic Goods Administration (TGA) has approved the new Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017. TGA anticipates that the updated Determination will be published and available on the Federal Register of Legislation (FRL) after 30 January 2017. The new Determination includes a total of 293 changes to ingredients available for use in listed medicines including the addition of 11 new ingredients and the deletion of one ingredient.   Source: via CMA, Permissible ingredients

TGA Consultation: Scheduling Medicines and Poisons

The Therapeutic Goods Administration is seeking comments from interested parties on proposed amendments to the Poisons Standard. The TGA has expanded the scheduling proposals for selected substances to be considered by the Advisory Committees on Chemicals and Medicines Scheduling (ACCS, ACMS) to promote relevant public submissions. This consultation closes on 10 February 2017.   Source: SUSMP consultation

TGA Reviews Scientific Literature on Sunscreen Actives

This scientific review report is limited to the review of safety concerns surrounding zinc oxide (ZnO) and titanium dioxide (TiO2) nanoparticles (NPs) present in sunscreens. The two main issues considered in this review are the evidence for the ability of these NPs to penetrate the skin to reach viable cells and the potential toxicity exerted by them. The TGA has been continuously monitoring the emerging scientific literature in this area and working cooperatively with international regulatory agencies to ensure that appropriate regulatory action is undertaken if any unacceptable risk of harm/toxicity is identified.   Source: Sunscreen lit-review

CMA Provides Update on Sansom Review of Medicines & Medical Devices

Complementary Medicines Australia has provided a summary of the two reports on the review to medicines and medical devices, together known as the Sansom Review. In September 2016, the Australian Government provided its written response to the Review, committing to the implementation 56 of the 58 recommendations. The recommendations will be implemented in a staged approach over the next 18-24 months to limit disruption to industry.   Source: Sansom report

TGA Recalls:

Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) - Consumers and health professionals are advised that Beijing Tong Ren Tang Australia, in consultation with the TGA, is recalling one batch of its Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) due to the presence of aristolochic acid. There is no established safe exposure level to aristolochic acids.   Source: Sports pill

The Cider Lab (assorted beverages) - Asahi Premium Beverages Pty Ltd has recalled The Cider Lab assorted beverages sold by liquor stores nationwide due to the presence of an undeclared allergen (sulphites)   Source: CiderLab

TGA Fact Sheet: Folate and Folic Acid for Use in Listed Medicines

This factsheet has been created for sponsors who wish to list folate products on the ARTG. It is intended to provide general information on the most commonly used folates and answer the most frequently asked questions. Folate, or vitamin B9, is an essential vitamin required by the human body for normal growth and development as it plays a critical role in the synthesis of DNA and RNA, and in the metabolism of certain amino acids. The term "folate" is actually a generic name for a group of related compounds with similar nutritional properties. The three most commonly used forms are folic acid, calcium folinate and levomefolate salts. All three forms can be incorporated into the body's metabolic pathways and may provide sources of the same biologically active form of folate – a compound known as 5-methyltetrahydrofolate (5-MTHF) or levomefolic acid.   Source: Folate

 

TGA Approves Permissible Ingredients (26BB) Determination No.1 of 2017

Complementary Medicines Australia advises that The Therapeutic Goods Administration (TGA) has approved the new Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017. TGA anticipates that the updated Determination will be published and available on the Federal Register of Legislation (FRL) after 30 January 2017. The new Determination includes a total of 293 changes to ingredients available for use in listed medicines including the addition of 11 new ingredients and the deletion of one ingredient.   Source: via CMA, Permissible ingredients

 

TGA Consultation: Scheduling Medicines and Poisons

The Therapeutic Goods Administration is seeking comments from interested parties on proposed amendments to the Poisons Standard. The TGA has expanded the scheduling proposals for selected substances to be considered by the Advisory Committees on Chemicals and Medicines Scheduling (ACCS, ACMS) to promote relevant public submissions. This consultation closes on 10 February 2017.   Source: SUSMP consultation

 

TGA Reviews Scientific Literature on Sunscreen Actives

This scientific review report is limited to the review of safety concerns surrounding zinc oxide (ZnO) and titanium dioxide (TiO2) nanoparticles (NPs) present in sunscreens. The two main issues considered in this review are the evidence for the ability of these NPs to penetrate the skin to reach viable cells and the potential toxicity exerted by them. The TGA has been continuously monitoring the emerging scientific literature in this area and working cooperatively with international regulatory agencies to ensure that appropriate regulatory action is undertaken if any unacceptable risk of harm/toxicity is identified.   Source: Sunscreen lit-review

 

CMA Provides Update on Sansom Review of Medicines & Medical Devices

Complementary Medicines Australia has provided a summary of the two reports on the review to medicines and medical devices, together known as the Sansom Review. In September 2016, the Australian Government provided its written response to the Review, committing to the implementation 56 of the 58 recommendations. The recommendations will be implemented in a staged approach over the next 18-24 months to limit disruption to industry.   Source: Sansom report

 

 

TGA Recalls:

Chinese Sports Injuries Pill (Zhong Guo Die Da Wan)

Consumers and health professionals are advised that Beijing Tong Ren Tang Australia, in consultation with the TGA, is recalling one batch of its Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) due to the presence of aristolochic acid. There is no established safe exposure level to aristolochic acids.   Source: Sports pill

The Cider Lab (assorted beverages)

Asahi Premium Beverages Pty Ltd has recalled The Cider Lab assorted beverages sold by liquor stores nationwide due to the presence of an undeclared allergen (sulphites)   Source: CiderLab

RFA Breaking News

Sydney Trade-only Expo

Naturally Good Expo 2017 RFA Regulatory Affairs will again have a stand at this year’s event on the 4th and 5th June in the new Complementary Medicines Pavilion – dedicated…

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Marketing News:

  Can the Blockchain be the Ultimate Guarantor of Supply Chain Accuracy? Frank Yiannas has spent years looking in vain for a better way to track lettuce, steaks and snack…

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Cosmetics:

  Australia’s Department of Health Seeks to Ban Cosmetic Testing on Animals During the 2016 Federal Election campaign, the Australian Government committed to introduce a ban on animal testing of…

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Foods:

  USA and Australia Recognise Food Safety Systems as Comparable Australia and the US have signed a bilateral food safety recognition agreement after five years of work.   Source: Joe Whitworth,…

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Complementary Medicines / “Dietary Supplements”:

  TGA Publishes Online Catalogue of Permitted Ingredients for Use in Listed Medicines The TGA is pleased to announce that an online catalogue of ingredients approved for use in listed…

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Healthy Products to Shine at Industry Trade Show in Sydney, June 2017

  As all of our readers will be aware, RFA Regulatory Affairs has played a vital role in providing compliance advice internationally for suppliers of complementary medicines, foods and cosmetics…

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