TGA Provides Technical Guidance on GMP Compliance for Listed Complementary Medicines

Recent TGA news releases have highlighted some of the important responsibilities mandated for both sponsors and manufacturers of listed complementary medicines. The TGA guidelines, although not mandatory or enforceable under law, provide interpretation and clarification of a number of issues and are very useful in understanding compliance with the PIC/S guide to GMP for medicinal products, which is mandatory. New and updated guidance documents:   Assessment, approval and qualification of suppliers of starting and packaging materials  ; Sampling and testing requirements ; Product Quality Reviews (PQR) ; Process validation ; On-going stability programmes

RFA Regulatory Affairs provides training courses for individuals, manufacturers, sponsors and their nominated pharmacovigilance staff via Skype or in person at our office in Glebe. We cover a range of topics, including product quality reviews, stability and TGA pharmacovigilance obligations and mandatory reporting requirements. To book a course, enquire about pricing, or if you have any questions on the topics covered, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it..

TGA Time Vs Industry Time When Processing GMP Clearance Applications

When assessing GMP Clearance (CV) applications the TGA has discovered that approximately 40% of these applications are incomplete. Historically, significant efforts were made to contact applicants and request them to provide the outstanding evidence, which involved several rounds of correspondence before it was provided to the TGA for assessment. This significantly contributed to the creation of a backlog of applications and led to extended processing times for CV's. In order to further improve the efficiency and transparency of the GMP Clearance process, and to ensure that applicants who provide complete applications are not disadvantaged, the TGA has started to accurately capture the processing times of CV applications by consistently applying a ‘stop clock process’ throughout the entire application and not just during the assessment stage.   Source: GMP clearance times (See also latest GMP guidance document   GMP clearance guidance update - Version 18.1 ).

TGA Answers Questions Regarding the Advertising Code

During recent TGA training sessions and webinars on the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), a large number of queries were received by the TGA organisers. Initially, a small number of answers to some of the most common questions are now being provided. These will be added to on a regular basis.   Source: Advertising code Q&A

TGA Consultation: Standards for Disinfectants; and Associated Guidance

This consultation reviews Therapeutic Goods Order 54. Hard surface disinfectants must meet all regulatory requirements as set out in TGO 54: Standard for Disinfectants (TGO 54) and associated guidance. This Order will sunset (cease) on 1 April 2019, therefore the TGA invites comments on their proposed update. This consultation closes on 12 February 2019.    Source: Disinfectant consultation

Australian Government Consultation: Complementary Medicine Country of Origin Labelling

The Department of Industry, Innovation & Science is coordinating a multi-agency taskforce, investigating the impact of use of the ‘Australian Made, Australian Grown’ logo in the complementary medicine sector. In particular, they are looking at vitamin, mineral and supplement products. They are currently seeking comments from Australian businesses directly involved in producing vitamins, minerals or supplements and/or those selling these products under a private label or brand. The survey will let them know your views on the use of the logo and country of origin labelling in general. Your views will help inform our assessment of the impact of the recent Country of Origin Labelling changes on the Australian complementary healthcare sector.   Source: CoOL consult

TGA Summarises Recent Important Developments in Therapeutic Goods Advertising Regulation

There have been many important developments in therapeutic goods advertising regulation over the last six months. This update provides a recap of some of the TGA's key achievements and outlines what they will focus on next. These recent regulatory changes include: a new advertising code; improved comprehensive training and resources; ministerial appointment of the Therapeutic Goods Advertising Consultative Committee; embedding a new risk-based approach to handling advertising complaints; publishing all 750 advertising complaint outcomes on our website in a searchable portal; &, addition of new enforcement powers.   Source: TGA advertising reforms

TGA Takes Action Against Peptide Clinics Pty Ltd for Alleged Advertising Breaches

Peptide Clinics Australia is alleged to have advertised compounded prescription only therapeutic goods, including 'peptides', on its website and other social media platforms, accessible to both registered customers and the public. It included references to serious forms of diseases, and to conditions such as anxiety and depression. These references require approvals or permissions, for which it is alleged there are none. The advertising is also alleged to be in breach of the Advertising Code because it contained statements, claims and implications that the advertised peptides were safe or alternatively could not cause harm, and encouraged inappropriate use of the medicines. The promotion of these peptides to consumers is also alleged to have contained scientific information that was inaccurate, imbalanced and misleading. Peptide Clinics Australia has given an undertaking to the Court that it would remove the relevant advertisements from its website pending final hearing of the matter. When the matter is heard by the Court later this year, the Court will be asked to impose financial penalties, and to issue declarations and final orders requiring the removal of any references for which approvals or permissions are required, as well as the removal of any other information in breach of the Advertising Code.   Source: Peptide advertising breach

South Australian Man Faces Criminal Charges for Dealing with Counterfeit and Unapproved Medicines

Following investigations by the Therapeutic Goods Administration (TGA) in November 2018, the Adelaide Magistrates Court has recently sentenced a South Australian man in relation to illegal acts involving counterfeit therapeutic goods. The man was charged with the following: 1 criminal charge of dealing with counterfeit therapeutic goods; 1 criminal charge of use of therapeutic goods in reliance of advertising that causes harm or injury to a person; 1 criminal charge of supply therapeutic goods in Australia not included on the Australian Register of Therapeutic Goods (ARTG); and 8 criminal charges of import therapeutic goods for use in humans not included on the ARTG. The man pleaded guilty to all of the above charges. The man was convicted of all counts, fined and sentenced to five months imprisonment that was suspended upon the man entering into a good behaviour bond for a period of two years. He was also ordered to pay prosecution costs.   Source: Counterfeit drugs crime

TGA Advises "Extreme Caution" After Detecting Cancer-Causing Contaminants in Chinese Herbal Pills

Australian regulator the Therapeutic Goods Administration (TGA) is advising "extreme caution" when purchasing health supplements online, after discovering cancer-causing contaminants in a Chinese herbal cough product.   Source: Cheryl Tay, Nutraingredients-Asia Toxic herbal pills

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi) – Contains sildenafil.

OA/RA capsules – Contains aristolochic acid.

NZ Consultation: Therapeutic Products Regulatory Scheme

The New Zealand Ministry of Health is seeking feedback on the draft of Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. This includes medicines (including cell and tissue products) and medical devices. Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process. Recognising the complexity of the Bill, and the impact of the holiday period, the consultation period will run for four months, ending 18 April 2019.   Source: NZ Bill consultation

RFA Breaking News

Complementary Medicines (“Dietary supplements”):

  TGA Advises on Using 'Natural' Claims When Advertising to the Public The TGA has released guidance on the use of 'natural' and related claims when advertising medicines and medical…

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Foods:

  Calls for Health Star Ratings on Packaged Food to be Compulsory The current use of ‘Health Star Ratings’ on packaged foods is not mandatory and is only being displayed…

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Cosmetics and TGA Listed Sunscreens

  Your Questions About the New NICNAS Scheme Get Answered As reported in May 2019 edition of this newsletter, there is now a new Australian industrial chemicals law – the…

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Marketing:

  Top Four Dietary Supplement Trends in New Zealand Revealed by National Industry Organisation Natural Health Products New Zealand has identified four trends driving dietary supplement market growth in the…

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Complementary Medicines (“Dietary supplements”):

  TGA Fees and Charges Summary from 1 July 2019 The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods…

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Foods:

  Raw Potential? New Zealand Opens Raw Milk Regulations Review for Consultation The New Zealand Ministry of Primary Industries (MPI) has launched an online survey seeking public consultation on the…

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