TGA News
Product recall
On 8 November 2010, APO-Perindopril 2mg tablets (blister packs of 30) 2mg perindopril erbumine per tablet (Batch 24967,24979, 25180, 25184)(ARTG 151911), were issued a Class I recall as some cartons labelled 2mg perindopril tablets may contain 8mg tablets. (Sponsor – Apotex Pty Ltd)
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[Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]
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Consumer safety advisory
The TGA is aware that some Australian consumers have purchased the products So Hard for Men, Shaguar and Pulse8 For Women over the internet or from an Australian retailer. The labels of each these three products claim them to be 100% herbal in origin. However, analyses undertaken by the TGA in Australia and the Institute of Environmental Science & Research Limited in New Zealand have confirmed the presence of therapeutic quantities of the drug tadalafil in each of these products. None of these products has been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and supply of any of them in Australia is illegal.
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Revised medicines and chemicals scheduling arrangements
Revised scheduling arrangements for medicines and chemicals took effect on 1 July 2010. The changes include:
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the National Drugs and Poisons Schedule Committee (NDPSC) will be replaced by the Secretary of the Department of Health and Ageing (DoHA) - or her delegate - as the decision maker for the scheduling of medicines and chemicals;
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two new expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, will be established to provide advice and make recommendations to the Secretary;
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a single Secretariat, supporting both Advisory Committees, will ensure ongoing consistency and cohesiveness of processes and decisions; and
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closer integration of the revised scheduling arrangements with existing Commonwealth evaluation and product registration schemes.
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Other planned changes include:
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the Poisons Standard, at present named the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), and
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cost recovery arrangements are being examined.
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The details of the new arrangements are summarised in a flowchart Read more ...
and fact sheet. Read more ...
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Review to improve transparency of the TGA
A determination of the Gillard Government to ensure the public is better informed about the benefits and risks of therapeutic goods is at the heart of a review recently announced by the Parliamentary Secretary for Health and Ageing, Catherine King. Ms King announced a comprehensive review of the way in which the TGA communicates its regulatory processes and decisions. The review will focus on improving the TGA’s transparency. The TGA is committed to improving its communication of regulatory decisions, and has already begun implementing a number of measures, including publication of:
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Reviews of post market supply investigations into products that have triggered significant safety concerns, including those into the recent Fluvax investigations;
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Product Information and Consumer Medicine Information for prescription medicines on the Therapeutic Goods Administration website;
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Action taken as a result of complaints referred to it by the Therapeutic Products Adverting Complaints Resolution Panel; and
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Results of Courts and Administrative Appeals Tribunal matters
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Advertising complaint investigations
The TGA's policy is to publish the outcome of certain investigations into complaints about advertising which have been referred by the Complaints Resolution Panel (the Panel). Where a person fails to acknowledge or act upon a determination made by the Panel or breaches an undertaking, the complaint may be referred to the TGA. Following consideration, the TGA may then order the advertiser to take an action such as withdraw an advertisement and publish a retraction or correction. These orders (known as Regulation 9 Orders) are made under Regulation 9 of the Therapeutic Goods Regulations 1990. Information on Regulation 9 Orders after 1 November 2010 will now be provided on the site as it becomes available.
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TGA approved terminology for medicines
The TGA has updated three forms for approved terminology for medicines. The application forms are for:
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proposing a botanical name for a herb (AHN)
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proposing a herbal substance name (AHS)
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proposing a herbal component name (HCN)
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Consultation: improving advertising arrangements for therapeutic goods
Submissions from interested parties were received by the TGA in response to the consultation paper on proposed amendments to the regulation of therapeutic goods advertisements. These can be downloaded from the TGA site.
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Australia and Canada - reciprocal recognition of manufacturers' quality systems
The TGA and Health Canada (HC) announced that the Memorandum of Understanding (MoU) on reciprocal recognition of quality management system (QMS) certificates for medical device manufacturers is now operational.
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SMP email list
This email subscription list notifies subscribers of new information available on the TGA website for the scheduling of medicines and poisons and the expert advisory committees on medicines and chemicals scheduling.
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Advisory committee on non-prescription medicines (ACNM)
The ACNM was formed in January 2010. The ACNM advise and make recommendations to the TGA regarding the entry of non-prescription medicines on the Australian Register of Therapeutic Goods. The ACNM supersedes the Medicines Evaluation Committee (MEC).
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Members for advisory committees on medicines and chemicals scheduling (updated))
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TGA-industry working group (IWG) meeting outcomes, 8 July 2010
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Therapeutic Goods Administration customer service charter
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European union guidelines
(10 guidelines adopted, 5 guidelines replaced/superseded and 1 guideline not adopted)
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Forms to request certificates, or notarised copies of TGA licences and certificates, in relation to the manufacture of therapeutic goods
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