Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

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

santa-in-australiaRobert Forbes & Associates, T/A RFA Regulatory Affairs will be closing its office over the Christmas break on the following dates: Closed Friday 23rd December 2016 and reopening on Tuesday 3rd January 2017.

Illegal Drugs Being Sold Openly In Some Australian Grocery Shops

A pill originally marketed as “Indian Viagra” and containing Opium is being openly sold in South Asian grocery stores in Australia. SBS Radio’s Punjabi program uncovered the illegal importation of the pill known as Kamini Vidrawan Ras (Kamini) after listeners raised concerns. The pill, which contains highly addictive substances as well as toxic heavy metals, is being sold as ancient Indian herbal therapy but there’s nothing holistic about it. Independent laboratory testing on products purchased in Melbourne revealed that the pills contain Codeine, Morphine and Papaverine — major components found in Opium.   Source: News.com.auOpium pills

Nurofen Headache Grows to $6 Million

RECKITT Benckiser’s $1.7 million fine for misleading claims about targeted pain relief has been increased to $6 million after an appeal by the consumer watchdog. In December, the Federal Court found that Reckitt Benckiser had engaged in misleading or deceptive conduct by claiming its Nurofen Specific Pain products treated a particular type of pain, when this was not the case. Australian Competition and Consumer Commission Chairman, Rod Sims said the decision was “very good news”, but reiterated the consumer cop’s view that penalties under consumer law should be brought in line with competition law. “In terms of the current consumer law we’re delighted with this level of penalty, it’s the maximum of $1.1 million per breach”.   Sources: Frank Chung, News.com.au Nurofen penalty ; ACCC report 

TGA Announces Review of Listed Sunscreen Products

The TGA will be initiating compliance reviews for listed sunscreens. The TGA follows a risk management strategy to set priorities and direct resources to reviews that provide the greatest overall benefit for the Australian public. Considering the seasonal significance of sunscreens, our current focus is to ensure that the quality, safety and efficacy of sunscreens are acceptable.   Source: Listed sunscreens

TGA presentation: Better medicine labels - New requirements under TGOs 91 and 92

Jenny Burnett, Scientific Operations Management Section, Scientific Evaluations Branch, Therapeutic Goods Administration, gave this presentation at the Royal Australian Chemical Institute (RACI) Pharmaceutical Chemistry Group NSW seminar on 22 November 2016. This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 91 and 92.   Source: Medicine label review

Codeine Medicines No Longer OTC and Will Soon be Prescription Only

The Therapeutic Goods Administration has recently announced that after a lengthy consultation and evaluation process all codeine based medicines will no longer be available over-the-counter and will be need to be acquired on a prescription-only basis, effective from 1st February 2018.   Source:Codeine rescheduled

Australian Labelling Requirements for Hazardous Chemicals in the Supply Chain

Chemicals manufactured or imported before 1 January 2017 can continue to be supplied without needing to meet the labelling requirements of the model Work Health and Safety Regulations. Safe Work Australia CEO Michelle Baxter said that Members agreed to this approach on 25 November 2016 in response to concerns raised by chemical suppliers. “This approach will ensure a smooth transition to the globally harmonised system, or GHS, and will avoid an unnecessary burden on suppliers to re-label existing chemical stock,” Ms Baxter explained.   Source:GHS WHS

ACCC Takes Action Over ‘Flushable’ Wipes

The Australian Competition and Consumer Commission is taking action against Kimberly-Clark and Pental alleging they made false or misleading representations and engaged in misleading and deceptive conduct in relation to “flushable” wipes. The ACCC alleges consumers were led to believe the products had similar characteristics to toilet paper, would break up or disintegrate in a time frame and manner similar to toilet paper, and were suitable to be flushed down the toilet — when this was not the case. The action follows a complaint by consumer group Choice, which singled out Kimberly-Clark’s Flushable Wipes for Kids for a “Shonky Award” in 2015.   Sources:Unflushable 'flushables' ; ACCC report

Department of Health Consults on Ban on Cosmetic Testing on Animals

During the 2016 Election campaign, the Australian Government committed to introduce a ban on animal testing of cosmetic products. The Government will ensure that the impact to business, trade and industry is taken into account and is minimised in the approach going forward, whilst continuing to maintain Australia’s high standards in protecting public health, worker safety and the environment. The Australian Government is in the initial stages of a phased consultation process to better understand and consider ideas, key issues and views in the development of the policy.   Source: Animal testing ban

Subcategories

Go to top