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 AdvisoriesSource: 2017 alerts    

Jimpness Beauty Fat Loss capsules: the capsules contain the undeclared substance phenolphthalein.

 

RFA Breaking News

Christmas Greetings

  Robert Forbes & Associates, T/A RFA Regulatory Affairs wishes all of our clients a Happy and Holy Christmas Holiday break. Our office will be closed from end of business…

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Complementary Medicines (“Dietary supplements”):

  ACCC Sues Voltaren Makers GlaxoSmithKline and Novartis for Misleading Consumers The Australian Competition and Consumer Commission watchdog is taking GlaxoSmithKline and Novartis to the Federal Court, alleging the global…

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Foods:

  Food Regulation in Australia and New Zealand This website provides information about the activities and processes in the joint Australia and New Zealand food regulation system, including roles and…

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Cosmetics (& Household cleaning products):

Aerosol Sunscreens May Leave You Burnt This Summer After a string of consumer complaints about the mists offering no protection, the Cancer Council has changed its tune and says it…

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Marketing News:

What Are The Latest Trends In The Personal Care Sector? Bans, restrictions, ingredient disclosure: these are the key chemical issues the personal care industries in Europe, the US and the…

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Training Course Update:

  NEW COURSE NOW AVAILABLE! Pharmacovigilance Obligations Training In September this year, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors…

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