Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
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 a new member of your regulatory or marketing team and would like them to be trained on food classifications and labelling in Australia? Do you want to supply cosmetics but aren’t quite sure what the label is required to look like?
RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements.
All courses are presented in a modular format of either two or three hour’s duration. Training resources are provided and certificates are presented to each participant at the successful conclusion of each module.
Pharmacovigilance Obligations Training
NEW COURSE NOW AVAILABLE
In September this year, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report. All required documents including SOPs and reporting templates will be provided for your future use.
This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance. This is all included in the price.
Nordoff-Robbins Music Therapy Corporate Christmas Cards
As per our usual practice, this year we are donating to Nordoff-Robbins Music Therapy (www.nordoff-robbins.com.au) in lieu of sending Christmas cards to clients. Nordoff-Robbins Music Therapy uses music to transform lives and bring the benefits of music therapy to those in need. You can also donate http://www.noro.org.au/support-us/donate-now. RFA Regulatory Affairs is a long-time supporter of Nordoff-Robbins Music Therapy Australia. http://www.noro.org.au/about/our-supporters You can be too!
Complementary Medicines ("Dietary supplements"):
New Database Portal for Complementary Medicine
The Karl und Veronica Carstens Foundation is launching a free database portal for complementary medicine, naturopathy and homeopathy. In total, 96,000 items of scientific literature, among them more than 30,000 clinical research papers and more than 9,000 basic research publications, can now be searched for free – a service unique in form and scale for scientists, practitioners, therapists and students. Source: Data portal
TGA Releases Latest Version of Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. This most recent Version 7.0 was released in October 2017 and has been re-structured to increase accessibility for intended users. Source: Reg. guidelines
TGA Presents Revised Draft List of Permitted Indications
The first draft list of permitted indications was published on 5 July 2017. A revised draft list has now been published to provide stakeholders with the opportunity to review and comment prior to the permitted indications reform coming into effect. Additional supporting materials have also been provided to assist stakeholders in understanding how the list will work and how the regulatory requirements for listed medicines will change. Sponsors should not make regulatory decisions based on this preliminary information, as changes may occur before finalisation and implementation of the supporting legislation. The revised draft list of permitted indications will be available on TGA website until 31 October 2017. Source: Permitted indications draft
TGA Publishes Outcomes of Advertising Complaints
The Therapeutic Goods Administration lists outcomes where the advertiser has taken specific action to address identified breaches of therapeutic goods advertising legislative requirements and is compliant at the date for which the complaint investigation was finalised. The advertiser's actions have been taken following TGA investigations into these complaints. All of these complaints were the subject of a complaint to the Complaints Resolution Panel. They were referred to the TGA for follow-up action because the advertiser did not fully comply with the Panel's request to address breaches of the therapeutic goods advertising legislation. Source: Advert outcomes
TGA Publishes Guidelines for Medicinal Marijuana
This guidance is for consumers, health professionals, sponsors and manufacturers who are involved in providing appropriate patients with access to medicinal cannabis products as an unapproved drug through the Special Access Scheme (SAS) or Authorised Prescriber Scheme. The term 'medicinal cannabis products' covers a range of cannabis preparations intended for therapeutic use, including pharmaceutical cannabis preparations, such as oils, tinctures and other extracts. Source: Medicinal pot
Editor’s note: For those interested in looking at TGA academic studies and research references on marijuana’s impact on pain relief and other medical conditions: Marijuana research
TGA Updates SUSMP ‘Poisons Standard’
The Poisons Standard has been presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia. The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). This latest update has particular relevance for those involved in the supply of cosmetics associated with the ingredients methylisothiazolinone, methylchloroisothiazolinone, and geraniol. Sources: SUSMP update ; & Legislation
TGA Announces Labelling Changes: Information for Sponsors
The TGA has made several amendments to the new labelling Orders TGO 91 & TGO 92. Many of the recent amendments were made as a direct result of feedback from industry stakeholders. The TGA has also introduced labelling requirements for medicines supplied in Australia. These changes were introduced on 31 August 2016 which started the four year transition period. Source: Label changes
TGA Publishes Presentations Given at Recent TGA Pharmacovigilance Inspection Program Information Sessions
Presentations cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections. Source: Pharmacovigilance
TGA Safety Advisories – Source: 2017 alerts
Jimpness Beauty Fat Loss capsules: the capsules contain the undeclared substance phenolphthalein.
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What You Need to Know About Australia’s Health Star Rating on Foods
The Federal Government's Health Star Rating claims to "take some of the guess work out of shopping" and help consumers "make smarter choices" when it comes to buying food. But when Milo, a chocolate powder that's almost 50 per cent sugar, clinches 4.5 (out of 5) stars, how much can we trust the system? Alexandra Jones from the George Institute for Global Health in Sydney told AM radio that the food industry is intentionally prolonging a review of the scheme's rules. "It's a well-known tactic of the food industry to ask for more evidence and consultation as a way of delaying meaningful public health policy," Ms Jones said. Source: ABC.net Food stars ;
Related story: Try this quick quiz Health Star Ratings: Can you guess which of these foods have more stars? Source: Food star quiz
Australia Food Safety Week
NSW Food Authority Recalls—
FSANZ Publishes Annual Report 2016-2017
Food Standards Australia New Zealand (FSANZ) supports and encourages the dissemination and exchange of information. FSANZ’s purpose is to contribute to the cooperative food regulatory system by developing evidence-based standards, providing evidence-based advice, coordinating regulatory responses and providing information about food standards. Source: Annual report
Application A1142 – Addition of Prescribed Method of Analysis for Resistant Starch: The purpose of the Application is to add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch). Source: Starch Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme): The purpose of the Application is to amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid. Source: B-galactosidase
Application A1150 – Glucosylated Steviol Glycosides: The purpose of the Application is to permit the use of glucosylated steviol glycosides as an intense sweetener in various foods. Source: Steviols
Proposal P1034 – Chemical Migration from Packaging into Food: The purpose of this Proposal is to assess the public health and safety risk of chemicals which may migrate from packaging materials into food, and to identify and manage any risks. Source: Plastics risk ; Editor’s note: due to “FSANZ’s risk assessment (concluding) that the human health risk posed by CMPF in Australia and New Zealand is low” it has therefore abandoned further study of this issue Summary & conclusion