RFA Regulatory Affairs

Latest Regulatory Affairs Newsletter

Consultant,

A collection of regulatory news from this month.

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

The Six Need-To-Know Regulatory Developments Set to Shape APAC’s Food and Beverage Industry in 2019

From sugar taxes to plastic waste bans, here are six regulation and policy updates that look set to heavily influence the APAC food industry in 2019, with the help of insights from major brands, academics and trade associations. Source: Pearly Neo and Tingmin Koe, Food Navigator-Asia Asia food regs 2019

FSANZ Notifications—

Application A1129 – Monk Fruit Extract as a Food Additive: The purpose of the Application is to permit monk fruit extract as a food additive, specifically as an intense sweetener. Source: Monk fruit

Application A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40: The purpose of this Application is to seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed. Source: Oleic safflower

Application A1157 – Enzymatic production of Rebaudioside M: The purpose of this Application is to seek approval for a new specification for rebaudioside M produced by an enzymatic biosynthesis method. Source: Rebaudioside M

Application A1158 – Rosemary extract as a food additive: The purpose of this Application is to seek approval to permit the use of rosemary extract as a food additive (antioxidant) Source: Rosemary

Application A1174 – Xylanase from Trichoderma reesei as a PA (Enzyme): The purpose of this Application is to permit the use of Xylanase from Trichoderma reesei as a processing aid. Source: Xylanase

December 2018 Failing Food Report

The Department of Agriculture and Water Resources targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at the rate of 100 per cent until a history of food safety compliance is established. When an emerging human health and safety hazard is identified in food, the department may temporarily increase monitoring and testing. This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of August. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, E coli, Bacillus cereus and Salmonella, as well as the toxins aflatoxin, lead, dimethoate and more. Source: Latest failed foods

FSANZ Biennial Stakeholder Forum - 5 March 2019

Food Standards Australia New Zealand (FSANZ) is a statutory authority in the Australian Government Health portfolio. FSANZ develops food standards for Australia and New Zealand and is holding its biennial forum on 5^th March 2019, in Sydney. Titled, ‘Fit For Purpose - Food Regulation Now And In The Future’, experts representing key stakeholders will explore topics relating to the food regulation system and will take a look into the future of food regulation, food safety and food science. The one day event will be followed by a cocktail reception. Source: FSANZ forum

Australian Natural Healthcare and Wellbeing Snapshot

The domestic Australian complementary medicine industry is robust and significant . Market research shows that the popularity of complementary medicines is increasing with a growth rate of seven per cent year on year. Three-quarters of Australians, including 92 per cent of women aged 20-24; take at least one complementary medicine and a quarter of the population visit complementary healthcare practitioners each year. In Australia, the fastest growth areas are nutritional oils, men’s health and eye health. Products are manufactured to some of the highest standards in the world based on GMP validation and stringent therapeutic regulations. These standards are maintained by the Therapeutic Goods Administration (TGA) through a transparent approval process, strict manufacturing compliance guidelines and effective post-market monitoring. The TGA register also supports the complementary medicine industry with evidence-based research, monitoring and safety data. These elements combine to allow Australian manufacturers to supply world-class products at globally competitive prices. Source: Austrade snapshot

Quote for the month:

“Stay away from negative people; they have a problem for every solution” Albert Einstein

Industrial Chemicals Reforms: Update on Implementation

The current regulatory scheme for industrial chemicals (NICNAS) will continue until the Australian Industrial Chemicals Introduction Scheme (AICIS) commences. The passage of the Industrial Chemicals legislation for the new scheme is now expected to be debated in the Senate in the first half of 2019. To assist regulated entities to adequately prepare for implementation of AICIS, the Government has decided to change commencement of the scheme to 1 July 2020. Government amendments to change the commencement date will be moved at the time of debate in the Senate. The Australian Government looks forward to implementing the ban on the testing of cosmetics on animals, that is included in the Industrial Chemicals Bill 2017. This ban will also commence on 1 July 2020. Source: NICNAS legislative update

Latest News on Plastic Microbeads Use in Australia

Microbeads are small, solid, manufactured plastic particles that are less than 5mm and don’t degrade or dissolve in water. They may be added to a range of products, including rinse-off cosmetics, personal care and cleaning products. Once flushed away, microbeads can have a damaging effect on marine life, the environment and human health. This is due to their composition, ability to adsorb toxins and potential to transfer up the marine food chain. The best way to reduce their impact is to prevent them from entering the environment. At a 2016 Meeting of Environment Ministers, ministers agreed to support a voluntary industry phase-out of plastic microbeads found in ‘rinse-off’ personal care, cosmetics and some cleaning products by July 2018. Source: Microbeads (See also Accord website Bead recede ; &, Environment ministers follow-up: Monitoring assurance protocol ).

Accord Initiative: What to do About Wipes

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. Wet wipes are single-use disposable cleaning cloths. Wipes continue to grow in popularity as a very convenient, hygienic and effective way to clean – whether it be a baby's bottom, household surface or for a specific commercial/industrial application. Unfortunately, where wipes are used – and what they are used for – can encourage flushing. This can lead to problems! Here’s everything you wanted to know about wipes and how best to dispose of them: Wipesmart

Listed Medicine Compliance Rating Scheme Has Begun

The TGA’s Listed Medicine Compliance Rating Scheme commenced on 28 November 2018 as part of its existing compliance review process. As listed medicines are not evaluated by the TGA before they are included on the Australian Register of Therapeutic Goods (ARTG), they conduct post-market compliance reviews on a proportion of those on the ARTG each year to ensure their ongoing safety, quality and efficacy. To support the publication of review outcomes on the TGA website, they have developed a Listed Medicine Compliance Rating Scheme (the Scheme). The Scheme is intended to aid consumers in interpreting the outcomes of compliance reviews after they get published on the TGA website. This will enable consumers to make informed choices about their use of self-selected medicines and provide an incentive for sponsors to improve overall compliance of their products. Source: Compliance rating scheme

TGA Fines Company Over $25,000 for Alleged Importation of Unapproved Therapeutic Goods

Australian company ESCHOICE Pty Ltd will pay penalties of over $25,000 after the Therapeutic Goods Administration (TGA) issued infringement notices for the alleged importation of unapproved therapeutic goods, namely medicines and medical devices for use in cosmetic procedures. Australian Border Force officers seized the imported therapeutic goods as part of Operation Antlia, a compliance initiative of the TGA. The TGA initiated Operation Antlia to target the illegal use of therapeutic goods in the cosmetics industry after a woman died from a cosmetic procedure at a Sydney clinic last year. Source: Operation Antlia

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation in December 2018. A total of 6 changes have been made in the updated Determination. These changes include changes to 5 existing ingredient entries, including making requirements clearer and less restrictive; and, removal of 1 ingredient that was a proprietary formulation and incorrectly classified as being appropriate for use in listed medicines during the drafting of the original Determination. The removed ingredient is not currently used in any listed medicines in Australia. Source: Permissible ingredients

TGA Consultation: Remaking Therapeutic Goods Order No. 78

The TGA is seeking comments from interested parties on the proposed remaking of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules and reintroducing pills into the remade Order. This consultation closes on 8 February 2019. Source: TGA 78 consultation

TGA Reviews the Narcotic Drugs Act 1967

The Narcotic Drugs Act establishes a framework to both prevent abuse and diversion of controlled narcotics and to ensure the availability of such drugs for medical and research purposes, in accordance with the Single Convention on Narcotic Drugs. Since October 2016, the Act was extended to provide for the regulation of cannabis cultivation and production in Australia, to enable a sustainable supply of safe medicinal cannabis products for therapeutic purpose. Source: Narcotics review

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

The Secretary of the Department of Health has begun Federal Court proceedings against Peptide Clinics Pty Ltd, trading as Peptide Clinics Australia, alleging breaches of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2015 (the Advertising Code). This legal action follows an investigation by the Therapeutic Goods Administration. 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. Source: Peptide Clinics busted

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

THAN YOU tablets: the tablets contain the undeclared substance sibutramine.

NZ Therapeutic Products Regulatory Scheme Consultation

New Zealand’s Ministry of Health is seeking feedback on the draft Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. Please note that 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. Source: NZ Therapeutic products bill

AHPA Issues Status Report on Hemp and CBD After USA Farm Bill Passage

The American Herbal Products Association has produced a Status Report after working with legal and industry experts to develop a new, free resource titled Status Report: Marketing of hemp and cannabidiol (CBD) products in the United States, following passage of the 2018 Farm Bill. This document provides concise and up-to-date information on the status of such operations and products as soon as this legislation is adopted as federal law. Because of the herbal product industry’s broad interest in the impact of this legislation on hemp and CBD, AHPA is distributing this information before the bill has been signed into law. The 2018 Farm Bill has been passed by the Senate and House, but still needs to be signed into law by the President. AHPA is not aware of any indications that successful and timely completion of this is in doubt. Source: 2018 Farm Bill passage