Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.



Robert 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.



TGA Issues Overview of Regulations for Medicinal Cannabis Products

This information about medicinal cannabis is for patients, health professionals, cultivators, manufacturers and researchers. The Australian Government is working towards facilitating access to medicinal cannabis products for patients with a medical condition for which there is evidence to support its use. Access to medicinal cannabis is highly regulated and is also affected by regulations of individual states and territories.   Sources: CBD regulations ; CBD access 


More news on medical cannabis can be found further into this newsletter



TGA Warns of TBS Planned Outage in December 2016

The Therapeutic Goods Administration is implementing a new financial system, SAP, which will go live in early December 2016. There will be a planned outage of the TGA Business Systems (TBS) portal from 17:00 (AEDST) 30 November 2016 to 09:00 (AEDST) 5 December 2016. If you need to submit an application at the start of December 2016, please ensure it is lodged before 5pm (AEDST) 30 November 2016.   Source: TGA planned outage


TGA Moves Ahead With Implementation of Complementary Medicine Reforms

The TGA is expecting to release public consultation papers to allow feedback on the implementation of the recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR). Because of the tight program to implement the reforms, public consultations will typically be open for a six week period. Targeted consultations will also be held with stakeholders to identify areas of regulatory burden that could be removed or business processes that could be streamlined to encourage innovation and improved access to products in the medicines sector. This forecast shows anticipated consultations for CMs commencing in the October 2016 - March 2017 period.   Source: CMA notice MMDR consultation ; TGA email list


TGA Consultation: The Regulatory Framework for Advertising Therapeutic Goods

The TGA is seeking comments from interested parties on the appropriate body or bodies for the handling of complaints under a new complaints-management system for therapeutic goods advertisements. This consultation closes on 21 December 2016.    Source:  TGA consultation


TGA Issues Safety Evaluation - Fennel oil

This Alert is to advise that the TGA has completed a safety evaluation of fennel oil, an ingredient used in a number of listed medicines. Fennel oil is currently available for use in listed medicines without restriction and is used as an active and/or excipient ingredient in various listed medicines. The TGA recently carried out a compliance review of a listed medicine containing fennel oil as an active ingredient intended for oral use in infants. During the review it was noted that several international regulatory agency reports state that fennel oil is contraindicated in children and adolescents under the age of 18.   Source: CMA Technical Alert Fennel oil safety


TGA Announces Delegates' Final Decisions on the Scheduling of Medicines and Poisons

Notice has been given of the delegates' final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision. Of most interest to the complementary medicines industry is the fate of Geraniol (and related compounds), and Isoeugenol.   Source: SUSMP final


TGA Answers: What is Pharmacovigilance?

The World Health Organization (WHO) describes pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This includes collection and evaluation of spontaneous case reports of suspected adverse events, as well as, pharmaco-epidemiology studies. Read this assessment from a regulators point of view:   Pharmacovigilance


TGA Issues List of Compositional Guidelines for Ingredients Permitted for Use in Listed Medicines.

In addition to the ingredients published in this list, suppliers should also refer to the default standards recognised in the Therapeutic Goods Act 1989, that is, the British Pharmacopoeia, United States Pharmacopoeia - National Formulary and the European Pharmacopoeia.  Source: Compositional guidelines  


TGA Presentation: Regulatory Reform - an Update

An update on TGA performance statistics, medicine labelling changes and the Review of Medicines and Medical Devices Regulation was given by John Skerritt, Deputy Secretary for Health Products Regulation, Commonwealth Department of Health at the recent ASMI Annual Conference. Topics covered included an update on TGA performance statistics, medicine labelling changes and the Review of Medicines and Medical Devices Regulation.   Source: TGA update


TGA Stakeholder Survey Results for 2016

This report provides a summary of findings from the 2016 Therapeutic Goods Administration stakeholder survey. An online survey was conducted amongst TGA stakeholders in July 2016. The survey provided opportunities for stakeholders to feedback to TGA across a range of service and activity areas. A total of 2,797 responses to the survey were received during the survey period, representing a response rate of 15%. Respondents represented a broad range of groupings, including strong representation from the medical products industry, community members, health professionals, academics and government stakeholders. Within these groupings, a broad range of participation was identified, including both large and small organisations, consumers, patients, carers, industry association representatives, advocates and sponsors.   Source: TGA survey


TGA Consultation: Designation of Australian Conformity Assessment Bodies for Medical Devices – Implementation

The Therapeutic Goods Administration is seeking comments from interested parties on the consultation paper for Designation of Australian conformity assessment bodies for medical devices. Interested parties should respond by close of business Wednesday, 11 January 2017.   Source: TGA consultation


TGA Recalls:

Health World Limited — Metagenics Nasoclear Nasal Spray 30mL

This recall effects a complementary medicine product that contains a saline solution scented with essential oils, having batch #80789, expiry date May 2018, and AUST L 166858. Some products from the affected batch may contain a pathogenic organism, Staphylococcus aureus, commonly known as golden staph.   Source: Nasoclear recall

Kaiser Pharmaceutical Traditional Chinese Medicine Products

Kaiser Pharmaceutical, in consultation with the TGA, is recalling one batch of each of three of their traditional Chinese medicine products. These products include certain Asarum species, which have been documented to contain aristolochic acid(s). There is no established safe exposure level to aristolochic acids, which have been linked to kidney problems and urinary tract cancers.   Source: Kaiser recall


NICNAS Requests Feedback for Cosmetic Testing on Animals - Online Survey

The National Industrial Chemicals Notification and Assessment Scheme, is the main Government body regulating the cosmetics industry in Australia. NICNAS is currently consulting on the implementation of an Australian Government commitment to ban the testing of cosmetics on animals. A background paper has been released and they are conducting an online survey to provide an opportunity for the general public and industry to provide input.   Source: Animal testing


Accord Initiative Debunks Myths Surrounding Cosmetics, Personal Care, and Household Products

Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic and specialty products, their raw materials suppliers and service providers. Is there lead in lipstick? Do sunscreens pose a health risk? And what does 'chemical free' or 'natural' really mean?  In this era of information overload, there are a lot of messages out there about chemicals, your health, and the safety of everyday products. Are these issues worth worrying about? Or are they 'beat-ups', alarmist scare stories or simply misinformed views with no basis in scientific fact?   Source: Furphies online


Australia and New Zealand Ministerial Forum on Food Regulation Communiqué

Communiqué of outcomes from the Australia and New Zealand Ministerial Forum on Food Regulation meeting held on 25 November 2016. Ministers discussed the current food regulation system and noted that there is a need to ensure it is responsive to changing trends in the food supply chain including foods that are new to the Australian and New Zealand diets.   Source: Food regulations


Investigation Shows Australian Supermarkets are Selling Dangerous or Banned Foods

SBS Radio’s Punjabi program exclusively investigated 18 common food products found in small grocery stores across Melbourne, including well-known brands of basmati rice, Indian spices and even Ghee (clarified butter). After receiving tip offs from listeners and social media posts, the radio program — lead by Walkley-nominated Executive Producer and Presenter Manpreet Kaur Singh — sent a selection of surveillance food products to a lab at the National Association of Testing Authorities.   Source: SBS Punjabi radio Toxic foods


FSANZ Notifications:

Application A1124 – Alternative DHA Algal Oil in Infant Formula

The purpose of the Application is to permit the addition of DHA-rich algal oil from Schizochytrium sp. as an alternative or replacement oil for other currently permitted DHA-rich algal oils added to infant formula products.   Source: Algal alternative

A1132 – Broaden Definition of Steviol Glycosides (Intense Sweetener)

The purpose of this Application is to expand the definition of steviol glycosides for use as an intense sweetener to include all steviol glycosides present in the Stevia rebaudiana leaf.   SourceStevia ; Intense sweeteners


NSW Food Authority Recalls:

Lite n Easy Traditional Favourites Chargrilled Steak

The NSW Food Authority advises that GD Mitchell Enterprises Pty Ltd (trading as Lite n Easy) has recalled Traditional Favourites Chargrilled Steak (two varieties) sold direct to consumers in NSW, ACT, QLD, VIC, SA and WA due to the presence of foreign matter (metal).   Source:Lite n Easy

Vegan Perfection Bonvita Rice Milk White Bar

JL Johnson & RM Palmer (trading as Vegan Perfection) has recalled Bonvita Rice Milk White Bar due to the presence of an undeclared allergen (milk).   Source: Bonvita


FSANZ Issues Updated ‘Safe Food Australia’ - A guide to the Food Safety Standards

Food Standards Australia New Zealand has reviewed Safe Food Australia to ensure it addresses current food safety issues and trends, contains up-to-date evidence and references and provides information targeted for temporary and mobile vendors and for home-based businesses.   Source:  Oz food safety


Investigation Shows Australian Supermarkets are Selling Dangerous or Banned Foods

SBS Radio’s Punjabi program exclusively investigated 18 common food products found in small grocery stores across Melbourne, including well-known brands of basmati rice, Indian spices and even Ghee (clarified butter). After receiving tip offs from listeners and social media posts, the radio program — lead by Walkley-nominated Executive Producer and Presenter Manpreet Kaur Singh — sent a selection of surveillance food products to a lab at the National Association of Testing Authorities.   Source: SBS Punjabi radio Toxic foods



ACCC Mandatory Reporting Requirements

Australian Competition & Consumer Commission reminds all suppliers that under Australian Consumer Law, suppliers are required to report any product-related death, injury and illness associated with a consumer product.   Source: Mandatory reporting


Next-Door Neighbours Suspected of Insider Trading Ahead Of Shanghai Pharma's Bid for Vitaco

Two couples living next to each other in a leafy Melbourne suburb are at the centre of a major insider trading investigation by the corporate watchdog. The investigation by the Australian Securities and Investments Commission centres on the alleged trading of shares in Australian-listed vitamin seller Vitaco ahead of the announcement of a $314 million takeover offer by Chinese companies Shanghai Pharma and Primavera Capital. Passports of four of the five suspects in the insider trading ring have been handed over to the Federal Court following departure banning orders handed down by Justice John Middleton.   Source: Sarah Danckert, SMH Vitaco traders


USA - New Dietary Supplement Product Registry Ready to Accept Product Labels

The Supplement OWL (Online Wellness Library) is now accepting product labels from dietary supplement finished product manufacturers and marketers as the product registry moves into its phase two of beta-testing. The Supplement OWL is now moving beyond the original beta-test and the Council for Responsible Nutrition (CRN), who is providing the initial funding and has been coordinating efforts with the industry, is urging companies to test out the product by inputting labels into the product registry prior to its public launch in January 2017.   Source: CRN Wellness library


Another Dairy Importer Suspended as China Officials Target Australian Firms

In a further sign that Chinese authorities are strengthening their supervision of imported infant formula, a major Australian manufacturer with a 100-year history has seen its Chinese business registration suspended.   Source: RJ Whitehead, Food Navigator-Asia Oz dairy fail


China Regulations - Chinese Food Safety Law

You may be aware of the second round of public consultation on the draft implementing regulations of the Chinese Food Safety Law.  Go to this site for an unofficial English translation of this 54 page draft, prepared by USDA Foreign Agriculture Service:  China food rules ; & US-China HPA  China market intel


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