Pharmacovigilance – important reading for all suppliers/sponsors and manufacturers of complementary medicines! This is an often overlooked responsibility and the TGA is now issuing fines for non-compliance - see next story. RFA offers a 1.5 hour course (much cheaper than getting a fine!) which includes a full set of documents and procedures. Courses are conducted by via Zoom, by appointment. This email address is being protected from spambots. You need JavaScript enabled to view it. for details or go here: https://rfaregulatoryaffairs.com/training-courses .

Information also publicly available on CMA website.

 

Compliance enforcement

Ferngrove Pharmaceuticals fined $13,320 for alleged breaches of legislation in relation to pharmacovigilance - failure to provide information on a contact person responsible for medicine safety.    TGA

Kardwi Pharmaceuticals fined $13,320 for alleged breaches of legislation in relation to pharmacovigilance - failure to provide information on a contact person responsible for medicine safety.    TGA

Shen Neng Herbal Medicines Group fined $53,280 for alleged breaches of legislation - breaching a condition of listing and failing to provide information to the TGA. The same company was fined $100,800 in 2020 in relation to breaches of supply, labelling and pharmacovigilance.    Source: TGA

Dentist fined $5,328 for alleged unlawful importation of Botox.    TGA

CheckMe fined $13,320 for alleged unlawful import of rapid antigen test kits.    TGA

G1 Resources fined $26,640 for alleged importation and advertising of unapproved rapid antigen tests.    TGA

Cat Media fined $39,960 for advertising unregistered weight-loss products. This is the third time that the TGA has issued such notices to Cat Media.    TGA

24K Rhino capsules – tested and found to contain undeclared sildenafil.    Source: TGA

 

Advertising Code. A very useful FAQ page, a “must” read. Explains some important issues especially testimonials and endorsements. This explains the TGA decisions. Other topics include mandatory statements, health warnings, short form advertisements, restricted representations and social media advertising.    Source: TGA

 

Transitioning to the new Therapeutic Goods Advertising Code. Mandatory statement requirements in the 2021 Code have been simplified and reduced in number.    Source: TGA

 

Training course in advertising: RFA offers a one hour training course on advertising. Information here: https://rfaregulatoryaffairs.com/training-courses

 

Reporting medicine adverse events – a presentation delivered by the TGA on 30th March.    Source: TGA

 

Urgent national product recall. iNova Pharmaceuticals has recalled a batch of Kynd Stress Relief tablets containing the equivalent of 6 g of Withania somnifera (Ashwagandha) per tablet, due to an unexpected number of allergic reactions.    Source: TGA

 

Ingredients permitted in listed medicines. Updated in April 2022, a list of the 2 added ingredients and 5 changed ingredients.    Source: TGA

 

Bacillus coagulans Strain MTCC 5856 a compositional guideline has been published.    Source: TGA

 

Good Manufacturing Practice – summary of TGA-Industry Working Group meeting on 25th February.    Source: TGA

 

TGA performance review. This covers the period 1st July to 31st December 2021, and includes processing and approval times. During this time there were 1,055 new listed medicine applications.    Source: TGA

 

Updates to standard for medicinal cannabis. Includes 2022 updates. This is for manufacturers and sponsors, to assist in ensuring medicinal cannabis products conform with Therapeutic Goods Order 93.    Source: TGA

 

Webinar: Medicinal cannabis reforms. Contents of a webinar delivered by the TGA explaining the changes to TGO 93.    Source: TGA

 

Approved COVID-19 rapid antigen self-tests. This list is regularly updates by the TGA.    Source: TGA

 

Medical devices reforms. Consumer Working Group of costumer and patient representatives meets regularly.  A small working group of volunteers formed the Medical Devices Action Plan Consumer Working Group.    Source: TGA

 

Therapeutic Goods Advertising Consultative Committee. Last met on 21st March. Among other issues, the Committee discussed the issue of the supply of therapeutic goods that are not included on the Australian Register of Therapeutic Goods (ARTG) and considered whether allowing references to the TGA in advertising would enable consumers to more easily distinguish therapeutic goods that are on the ARTG.    Source: TGA

RFA Breaking News

Cosmetic, Personal Care and TGA Listed Sunscreens:

Guide to categorising your chemical importation and manufacture. Updates to the guide.    Source: AICIS   Draft evaluation of a chemical with CAS number 1428963-39-6. Call for comment, deadline 3rd…

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Foods:

Imported kava – update to the definition of permitted kava products and labelling requirements for retail ready packs and bulk imported kava not for immediate retail sale.    Source: Dept…

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Complementary Medicines and Medical Devices:

Pharmacovigilance – important reading for all suppliers/sponsors and manufacturers of complementary medicines! This is an often overlooked responsibility and the TGA is now issuing fines for non-compliance - see next…

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Cosmetic, Personal Care and TGA Listed Sunscreens:

Download a list of chemicals on the inventory. AICIS has published a downloadable spreadsheet containing all the chemicals on their database. However this may not be very useful as it…

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Foods:

Do you import kava for sale or wholesale in NSW? From 1 December last year, commercial imports of kava from Pacific Island nations resumed. From this date, importers have been able…

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Complementary Medicines and Medical Devices:

Poisons standard: “Interim Decisions” in relation to substances including cannabis and tetrahydrocannabinols, choline salicylate, chromates and chromium trioxide, and other ingredients.    Source: TGA.   Listed medicine compliance reviews. Updated…

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