Abrilada

Source: Australian Therapeutic Goods Administration

Rheumatoid arthritis

Abrilada is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.

Abrilada can be used alone or in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Abrilada in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDs). Abrilada can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enthesitis-related arthritis

Abrilada is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.

Psoriatic arthritis

Abrilada is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.

Ankylosing spondylitis

Abrilada is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Abrilada is indicated for the treatment of moderate to severe Crohn’s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;

Crohn’s disease in adults and children (≥ 6 years)

  • who have had an inadequate response to conventional therapies or,
  • who have lost response to or are intolerant to infliximab.

Ulcerative colitis

Abrilada is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties – clinical trials).

Psoriasis in adults and children

Abrilada is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Abrilada is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Hidradenitis suppurativa in adults and adolescents (from 12 years of age)

Abrilada is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Uveitis

Abrilada is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Webinar: Special Access Scheme (SAS) Portal Update

Source: Australian Department of Health

A walk-through of the changes to the SAS and Authorised Prescriber Online System.

Background

The SAS and AP Online System is being upgraded and as a result there will be some minor changes to the look and feel, as well as some new enhancements. The SAS Category B online form has been updated to reflect the legislative changes made in NSW, ACT, VIC and QLD. The AP dashboard now includes a streamlined application for nicotine prescribing and the ability to submit six monthly patient data reports.

How do I register?

Webinar session 1

  • Date: Wednesday, 10 March 2021
  • Time: 10am-11am
  • Where: Online webinar

Register for webinar

Webinar session 2

  • Date: Thursday 11 March 2021
  • Time: 2pm-3pm
  • Where: Online webinar

Register for webinar

Consultation: Proposal for clarifying regulatory requirements for residual claims for disinfectants

Source: Australian Therapeutic Goods Administration

This consultation closes on Wednesday, 26 March 2021.

The Therapeutic Goods Administration (TGA) has received a number of enquiries relating to residual activity claims for disinfectants, including whether statements can be made for disinfectants such as ‘residual activity for up to 30 days’, and what testing methods should be used to provide evidence for these claims.

At present, there is no definition of “residual activity” included in the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) 2019 (the Order) or the TGA published guidance document: TGA Instructions for Disinfectant Testing. There are also no defined test methods or specified acceptance criteria for such testing. To date, claims have been considered (and continue to be considered) by the TGA assessors on a case by case basis.

We invite you to review the consultation paper Proposal for clarifying regulatory requirements for residual claims for disinfectants and provide a response using our online survey, both of which are accessible through our consultation hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.

Feedback from the Consultation Paper may inform changes to the regulatory framework, including the TGO 104 or other accompanying documentation relating to disinfectants.

TGA collecting COVID-19 vaccine side effect reports

Source: Australian Therapeutic Goods Administration

Australia’s safety monitoring system for COVID-19 vaccines is operating and weekly reports will be published from this Wednesday.

The Therapeutic Goods Administration (TGA) is collecting and evaluating reports of suspected side effects following the start of Australia’s COVID-19 vaccine program.

Like other medicines and vaccines, COVID-19 vaccines can cause side effects (also known as adverse events). Side effects, if they occur, are usually mild and temporary, lasting one or two days.

To the end of 28 February 2021, the TGA had received 79 reports of suspected adverse events related to the COVID-19 vaccine. The reports received so far are within normal expectations for any vaccine. Early reports have most frequently included cases of feeling faint, headache, dizziness or nausea. Two cases of administration error in a Brisbane aged care facility have also been reported to the TGA and to date have not been associated with any adverse outcome.

In addition, the National Centre for Immunisation Research and Surveillance (NCIRS) is funded by the Australian government to run the AusVaxSafety active surveillance program. AusVaxSafety sends some people who receive COVID-19 vaccines (or their carers) follow-up SMS messages with a survey about potential side effects. AusVaxSafety has received over 5000 responses from people across the country who received the vaccine in the first three days of the rollout. Early data shows that approximately one third of people who responded reported at least one expected side effect, most commonly soreness at the injection site, headache and fatigue.

The TGA will publish weekly updates on the number of COVID-19 vaccine adverse event reports received beginning this Wednesday, 3 March 2021. Subsequent weekly reports will also include commentary relating to our safety monitoring and assessment of this data.

We will also publish safety alerts and media releases in response to any significant new safety issues.

The TGA collects adverse event reports directly from health professionals and consumers, as well as through state and territory health departments, other Australian vaccine safety organisations and vaccine sponsors. We review adverse event reports to look for any patterns that indicate a possible safety issue that should be investigated. We thoroughly investigate these issues to determine what action is required, if any, to maintain public safety.

Learn more about how the TGA is monitoring the safety the of COVID-19 vaccines, including how to report adverse events, and how we are communicating about COVID-19 vaccine safety.

Proposal for clarifying regulatory requirements for residual claims for disinfectants

Source: Australian Therapeutic Goods Administration

This consultation closes on Wednesday, 26 March 2021.

The Therapeutic Goods Administration (TGA) has received a number of enquiries relating to residual activity claims for disinfectants, including whether statements can be made for disinfectants such as ‘residual activity for up to 30 days’, and what testing methods should be used to provide evidence for these claims.

At present, there is no definition of “residual activity” included in the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) 2019 (the Order) or the TGA published guidance document: TGA Instructions for Disinfectant Testing. There are also no defined test methods or specified acceptance criteria for such testing. To date, claims have been considered (and continue to be considered) by the TGA assessors on a case by case basis.

We invite you to review the consultation paper Proposal for clarifying regulatory requirements for residual claims for disinfectants and provide a response using our online survey, both of which are accessible through our consultation hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.

Feedback from the Consultation Paper may inform changes to the regulatory framework, including the TGO 104 or other accompanying documentation relating to disinfectants.

Update to listed medicine ingredients in March 2021

Source: Australian Therapeutic Goods Administration

2′-Fucosyllactose

Addition

3-(Methylthio) propionaldehyde

Addition

C15-16 Isoparaffin

Addition

C17-18 Isoparaffin

Addition

Fully hydrogenated rapeseed oil

Addition

Acetyl glucosamine

Change

Alginate-konjac-xanthan polysaccharide complex

Change

Alpha casozepine enriched hydrolysed milk protein

Change

Aluminium magnesium silicate

Change

Aluminium sodium silicate

Change

Amylase

Change

Andrographis paniculata

Change

Arachis hypogaea

Change

Arachis oil

Change

Aspartame

Change

Benzyl benzoate

Change

Bittern

Change

Blackstrap molasses

Change

Bovine colostrum powder

Change

Bovine lactoferrin

Change

Bovine whey Ig-rich fraction

Change

Bromelains

Change

Butyl hydroxybenzoate

Change

Caffeine

Change

Calcium folinate

Change

Calcium sodium caseinate

Change

Canarium indicum

Change

Cellulase

Change

Change of name from Ledum groenlandicum to Rhododendron groenlandicum

Change

cis-3-Hexen-1-ol

Change

Conium maculatum

Change

Croscarmellose sodium

Change

Dibasic magnesium phosphate trihydrate

Change

Dibasic sodium phosphate

Change

Dibasic sodium phosphate dihydrate

Change

Dibasic sodium phosphate dodecahydrate

Change

Dibasic sodium phosphate heptahydrate

Change

Dibasic sodium phosphate monohydrate

Change

Disodium edetate

Change

Dried magnesium sulfate

Change

Ethanol absolute

Change

Ethyl hydroxybenzoate

Change

Euphausia superba oil

Change

Folic acid

Change

Formic acid

Change

Fortified wine

Change

Glucosamine hydrochloride

Change

Glucosamine sulfate

Change

Glucosamine sulfate potassium chloride

Change

Glucosamine sulfate sodium chloride

Change

Glucose

Change

Glucose monohydrate

Change

Goat milk

Change

Golden syrup

Change

Grape wine red

Change

Grape wine sherry

Change

Grape wine white

Change

Heavy magnesium oxide

Change

Honey

Change

Honey extract

Change

Invert sugar

Change

Invert syrup

Change

Isobutyl hydroxybenzoate

Change

Isomalt

Change

Isopropyl 4-hydroxybenzoate

Change

Lactitol

Change

Lactitol monohydrate

Change

Lactose

Change

Lactose monohydrate

Change

Levomefolate calcium

Change

Levomefolate glucosamine

Change

Light magnesium oxide

Change

Lipase

Change

Liquid glucose

Change

Magnesium amino acid chelate

Change

Magnesium chloride 4.5-hydrate

Change

Magnesium chloride hexahydrate

Change

Magnesium hydrogen phosphate

Change

Magnesium hydroxide

Change

Magnesium oxide

Change

Magnesium phosphate pentahydrate

Change

Magnesium phosphate tribasic

Change

Magnesium sulfate dihydrate

Change

Magnesium sulfate heptahydrate

Change

Magnesium sulfate monohydrate

Change

Magnesium sulfate trihydrate

Change

Magnesium trisilicate

Change

Maltitol

Change

Maltitol solution

Change

Maltose

Change

Mannitol

Change

Methyl hydroxybenzoate

Change

Monobasic sodium phosphate

Change

Monobasic sodium phosphate dihydrate

Change

Monosodium dihydrogen citrate

Change

Nicotinamide riboside chloride

Change

Nonfat dry milk

Change

Omega-3-acid ethyl esters 90

Change

Palmidrol

Change

Para-propyl anisole

Change

Peanut

Change

Permethrin

Change

Phenylalanine

Change

Poliglusam

Change

Poliglusam derived from Aspergillus niger

Change

Potassium chloride

Change

Potassium sorbate

Change

Propyl hydroxybenzoate

Change

Protease

Change

Purified honey

Change

Riboflavin sodium phosphate

Change

Rice wine

Change

Saccharin

Change

Saccharin sodium

Change

Sodium acetate

Change

Sodium acid citrate

Change

Sodium ascorbate

Change

Sodium benzoate

Change

Sodium beta-hydroxy-beta-methylbutyrate

Change

Sodium bicarbonate

Change

Sodium bisulfite

Change

Sodium carbonate

Change

Sodium carbonate monohydrate

Change

Sodium citrate

Change

Sodium citrate dihydrate

Change

Sodium cyclamate

Change

Sodium erythorbate

Change

Sodium fluoride

Change

Sodium fumarate

Change

Sodium glycerophosphate

Change

Sodium hydroxide

Change

Sodium hypochlorite

Change

Sodium lactate

Change

Sodium laureth sulfate

Change

Sodium lauryl phosphate

Change

Sodium lauryl sulfate

Change

Sodium metabisulfite

Change

Sodium methyl hydroxybenzoate

Change

Sodium monofluorophosphate

Change

Sodium pantothenate

Change

Sodium perborate

Change

Sodium propionate

Change

Sodium propyl hydroxybenzoate

Change

Sodium silicate

Change

Sodium starch glycollate

Change

Sodium starch glycollate type A

Change

Sodium sulfate

Change

Sodium sulfate decahydrate

Change

Sodium sulfite

Change

Sodium sulfite heptahydrate

Change

Sorbic acid

Change

Sorbitol solution (70 per cent) (crystallising)

Change

Sorbitol solution (70 per cent) (non-crystallising)

Change

Sucrose

Change

Sucrose laurate

Change

Sucrose octaacetate

Change

Sugarcane

Change

Sulfur dioxide

Change

Tartrazine

Change

Tartrazine aluminium lake

Change

Tetrasodium pyrophosphate

Change

Tilactase

Change

Treacle

Change

Tribasic sodium phosphate

Change

Whole dry milk

Change

Xylitol

Change

Chloroacetamide

Removal

Gynura japonica

Removal

Psoralen (of Cullen corylifolium)

Removal

Vocabria

Source: Australian Therapeutic Goods Administration

Vocabria should be prescribed by a physician experienced in the management of human immunodeficiency virus (HIV) infection.

Vocabria is indicated for the treatment of HIV-1 in combination with rilpivirine, therefore, the product information for rilpivirine should be consulted for recommended dosing.

Adults

Oral lead-in dosing

Vocabria tablets are recommended for approximately one month (at least 28 days) in virologically suppressed patients prior to the initiation of cabotegravir injections, a component of Cabenuva (cabotegravir and rilpivirine prolonged release suspensions for injection), to assess tolerability to cabotegravir. One Vocabria tablet (30 mg) should be taken with one rilpivirine tablet (25 mg) once daily.

The final oral dose should be taken on the same day injections with Cabenuva are started.

Elderly

No dose adjustment is required in elderly patients. There are limited data available on the use of cabotegravir in patients aged 65 years and over (see Section 5.2 Pharmacokinetic Properties, Special Patient Populations in the Product Information).

For further information refer to the Product Information.

Consultation: Proposed regulatory options for medical devices containing nanomaterials

Source: Australian Therapeutic Goods Administration

This consultation closes on Wednesday, 9 April 2021.

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program.

In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) made 58 recommendations for reform of the regulatory framework for medicines and medical devices in Australia. The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released in September 2016. The Government accepted 56 MMDR recommendations including Recommendation Twenty which provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework including the classification of medical devices.

The EU introduced a new medical device regulatory framework from 2017, which included new requirements around nanomaterials. This paper examines whether the Australian medical device regulatory framework should be aligned to the EU framework for medical devices containing nanomaterials, and how this could occur.

We invite you to review the consultation paper and provide a response using our online survey, both of which are accessible through our consultation hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.

Bajaria Global Pty Ltd fined $26,640 for alleged unlawful importation of therapeutic goods containing betel nut (areca nut)

Source: Australian Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Perth-based company Bajaria Global Pty Ltd (Bajaria Global) for alleged unlawful importation of therapeutic goods containing betel nut under the Therapeutic Goods Act 1989 (the Act).

Bajaria Global allegedly imported two Pan Masala therapeutic goods for use in humans that contained betel (areca) nut. At the time of importation, the products were not included in the Australian Register of Therapeutic Goods (ARTG) and were neither exempt nor excluded from the operation of the Act. Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia.

Betel nut is the seed of the Areca palm (Areca catechu) and is a Schedule 4 (prescription only) medicine because it contains arecoline and related substances (see the Poisons Standard). The Indian Journal of Medical and Paediatric Oncology published a review of the systemic adverse effects of betel nut. The journal article indicates betel nut is an addictive substance associated with a range of harmful health effects, including mouth and throat cancer. Consuming betel nut while pregnant may also be harmful to the unborn baby.

The TGA’s highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.

The TGA takes action against breaches of the Act

The regulatory scheme is critical to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.

If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.

Haimex International Pty Ltd fined $53,280 for alleged unlawful importation of medical devices

Source: Australian Department of Health

The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued four infringement notices totalling $53,280 to Sydney-based company Haimex International Pty Ltd (Haimex International) for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads under the Therapeutic Goods Act 1989 (the Act).

Haimex International allegedly imported the products, which had not been included in the Australian Register of Therapeutic Goods (ARTG), and were neither exempt nor excluded from the operation of the Act. Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia. The TGA notified Australian Border Force that the goods should be seized.

Demand for thermometers in Australia has increased due to the COVID-19 pandemic. The TGA has published regulatory guidance to support business with submitting their applications for thermometers to be included in the ARTG.

Unapproved therapeutic goods imported unlawfully are of unknown reliability, and their importation in the context of the pandemic is of significant concern to the TGA.

The TGA’s highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.

The TGA takes action against breaches of the Act

The regulatory scheme is critical to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.

If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.