TGA News
Proposed section 7 declaration
In Australia there is a legislative overlap between foods and medicines for human oral consumption, and as the food and complementary medicine sectors have evolved over recent years, a 'grey area' has unintentionally developed at this food-medicine interface. The confusion is due to certain areas of food legislation and therapeutic goods legislation overlapping in such a way that makes it difficult to determine which legislation should be applied. The TGA and FSANZ have recognised that the food-medicines interface confusion is heightened by the practice of presenting certain foods in capsule, tablet or pill form. This form of presentation, except in the case of unmedicated confectionary, gives the impression that the product is a medicine.
The current proposal to declare (under Section 7 of the Therapeutic Goods Act 1989) that goods presented for oral consumption in tablet, capsule or pill form are therapeutic goods, aims to resolve many of these issues and clarify regulatory requirements for industry.
Comments on this proposal are invited by close of business Monday 30 November 2009.
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Composition of Ginkgo biloba products
There are currently more than 400 products that contain ginkgo on the Australian Register of Therapeutic Goods (ARTG). The TGA has recently conducted testing on twenty-two (22) batches of medicines, covering twenty (20) products, and a number of associated ginkgo extract raw materials. The testing focused on determining the quality of the ginkgo extract used in the formulation of the medicines. In some of the samples tested, elevated levels of quercetin and rutin were noted. These are naturally occurring components found in ginkgo and many other plants. Variation in the content of these components may occur due to natural variation in the plants or the processing and storage of the herbal material. The TGA is currently working with its expert advisory committees and the complementary medicine industry associations to refine the quality standards for ginkgo extracts used in medicines available in Australia.
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Draft guidance on the use of the term 'quantified by input' for listed complementary medicines
Since the implementation of the original QBI guidance document 'Guidance on the use of the term 'quantified by input' for listed complementary medicines' in January 2007, it has become evident that a number of issues central to its application require further clarification. After extensive consultation between TGA and industry, revised documents have been prepared including: an explanatory note, new guidance document and a Q&A document.
Comment submissions should be submitted to the TGA by 4 November 2009.
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CMEC 72nd meeting
Recommendations by CMEC to the TGA are as follows:
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Permitted indications for cholesterol claims
The following coded indications are acceptable for medicines making claims in relation to cholesterol:
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'May help maintain normal [and/or healthy] cholesterol levels'.
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'May help maintain normal [and/or healthy] cholesterol levels'.
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The following label advisory statement is recommended:
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'Not for the treatment of high cholesterol. Blood cholesterol levels should be regularly checked'.
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Calci-tab 600 - suitable for registration in the ARTG, subject to the appropriate
labelling requirements.
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Safety cut off limit for aristolochic acids in listed medicines - any herbal species confirmed as containing aristolochic acids is not suitable for inclusion in listed medicines, as there is insufficient justification for any cut-off to be applied to preparations of such species.
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Safety of Asarum species as ingredients in listed medicines - Asarum spp. are no longer suitable for inclusion in listed medicines, due to the increased potential for preparations of this genera to contain aristolochic acids.
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Review of black cohosh reports - there is currently insufficient evidence to warrant a change to the current regulation and labelling of products containing preparations of Cimicifuga racemosa.
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Manufacturing principles - new/amended requirements
On 29 July 2009 new principles were introduced for manufacturers of medicinal products bringing Australian manufacturing requirements into line with current international practices by adopting the PIC/S Guide for Good Manufacturing Practice for Medicinal Products. The PIC/S Guide also incorporates the ICH Harmonised Tripartite Guideline Good Manufacturing Practice for Active Pharmaceutical Ingredients.
This document identifies the major changes associated with the adoption of the 2009 PIC/S Guide compared to the current Australian Code of Good Manufacturing Practices for Medicinal Products, 2002.
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TGA approves vaccine against Pandemic (H1N1) 2009 influenza
The TGA has approved the registration of Panvax® H1N1 influenza vaccine, for use in adults and children 10 years of age and over.
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Presentations given by the TGA office of manufacturing quality
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Ensuring efficient and effective GMP compliance in challenging times (Michael Lok)
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Changes to manufacturing standards, implementation of quality risk management and other
TGA program updates (Noel Fraser)
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Manufacturing quality program – proposed cGMP human tissues (Michael Lok)
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Quality risk management – TGA perspective (Anthony Gould and Mark Dickson)
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The TGA and proves analytical technology (D Fenwick)
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Questions & answers relating to the additional default standards legislation
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