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.
Read more ...
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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Draft guidance on the use of the term 'quantified by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 Panvaxฎ H1N1
influenza vaccine, for use in adults and children 10
years of age and over.
Read more ...
Reporting of side effects ... |
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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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