Current Affairs
Issue 96 - October 2009 Published by Robert Forbes & Associates Pty Ltd
http://www.robert-forbes.com/
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RFA
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RFA News
Do your products meet AQIS requirements?
Australian Quarantine and Inspection Service (AQIS) is concerned with ingredients of biological origin which are imported into Australia or exported. Some biological origin ingredients require quarantine permits or there may be other quarantine prerequisites. If you are not sure of your responsibilities, RFA can review ingredients and ensure your products meet current AQIS requirements and apply for permits as necessary.

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Medicines
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 ...

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:
Permitted indications for cholesterol claims
The following coded indications are acceptable for medicines making claims in relation to cholesterol:
•  'May help maintain normal [and/or healthy] cholesterol levels'.
•  'May help maintain normal [and/or healthy] cholesterol levels'.
The following label advisory statement is recommended:
•  'Not for the treatment of high cholesterol. Blood cholesterol levels should be regularly checked'.
Calci-tab 600 - suitable for registration in the ARTG, subject to the appropriate
labelling requirements.
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.
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.
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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Therapeutic goods (listing) notice (No’s 2, 3, 4 and 5)
In September 2009, the following can be included for oral use as therapeutically active ingredients in listed goods:
preparations that contain sodium citrate
preparations that contain sodium acid citrate
preparations that contain potassium chloride for oral rehydration therapy, subject to conditions
preparations that contain sodium bicarbonate for oral rehydration therapy, subject to conditions
preparations that contain "bovine whey Ig-rich fraction", subject to conditions
Listing Notice No 2 ...
Listing Notice No 3 ...
Listing Notice No 4 ...
Listing Notice No 5 ...
Draft compositional guideline for bovine whey Ig-rich fraction

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.
Read more ...
Reporting of side effects ...

Presentations given by the TGA office of manufacturing quality
Ensuring efficient and effective GMP compliance in challenging times (Michael Lok)
Changes to manufacturing standards, implementation of quality risk management and other
TGA program updates (Noel Fraser)
Manufacturing quality program – proposed cGMP human tissues (Michael Lok)
Quality risk management – TGA perspective (Anthony Gould and Mark Dickson)
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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Update of recall co-ordinators contact list
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European Union guidelines (updated)
EU guidelines recommended for adoption or non-adoption.
Read more ...
Guidelines proposed for adoption in Australia ...

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Foods
FSANZ (Food Standards Australia New Zealand) update

Iodine to be added to bread
The essential nutrient iodine will be added to bread, through the addition of iodised salt, in Australia from 9 October 2009 to help address the re-emergence of iodine deficiency across most of the population.
Read more ...

FSANZ invites public comment on changes to food laws
The changes under consideration concern the use of phytosterols in food and national food safety standards for eggs and egg products and for meat and meat products. FSANZ welcomes public comment by 11 November 2009 (A1019) and 25 November 2009 (P1005 and P301).
Read more ...

Amendment 112 gazetted
Amendment No 112 was gazetted on 17 September 2009 in Australia and published in the New Zealand Gazette on the same day. The Applications under which these amendments are made are:
Application A614 – Food derived from Glyphosate-tolerant Cotton Line GHB614
Application A615 – Food derived from Insect-protected Cotton Line COT67B
Read more ...

Mandatory folic acid to be added to bread-making flour in Australia
Effective Sunday 13 September 2009, bread-making flour in Australia must have folic acid, a form of the B vitamin folate, added to it to reduce the risk of babies being born with birth defects such as spina bifida.
Read more ...

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Association News
Natural Products New Zealand (NPNZ)

2010 Natural Products Summit
Natural Products New Zealand has set the date for the 2010 Natural Products Summit. Mark April 22, 2010 in your diary now!

www.naturalproductsnz.org

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Conferences & Meetings
TGA seminars on manufacturing principles for medicinal products
October 20, Etihad Stadium, Docklands, Victoria
November 9, Ryde-Eastwood Leagues Club, West Ryde, NSW
November 18, details TBC, QLD
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Supply Side West
November 11 – 13, The Venetian and Sands Expo, Las Vegas
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TGACC advertising seminars – Fundamentals 9-4pm
Nov 6 – Brisbane
Nov 18 – Adelaide
Nov 20 – Perth
Nov 25 – Sydney
Dec 8 - Melbourne
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ASMI Annual Conference & AGM
November 12, Australian Technology Park, Redfern Sydney
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Panacea 2010
February 3 – 5, 2010 World Trade Centre, Mumbai, Maharashtra, India
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Biofach Germany
February 17 – 20, Exhibition Centre Nuremberg, Germany
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Natural Products Expo West
March 11 – 14, 2010 Anaheim Convention Centre, California, USA
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GMP Management Course
ASMI in partnership with the Advanced Manufacturing Centre and the University of NSW has created a course on GMP management which culminates in a graduate certificate. This course is open to members and non-members of ASMI.
Read more ...

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RFA Training Courses
New course now available for marketing staff – an overview of the TGA regulations including advertising regulations for foods, medicines and cosmetics.
Details at www.robert-forbes.com/training-courses.html

Half day (4 hour) courses
•  Overview of the food/therapeutic/cosmetic interface
•  Cosmetic regulation
•  Medicines - advertising code
•  Medicines - product claims and indications
•  Listed complementary medicines - TGA eBS online applications
•  Medicines – the sponsor’s finished product specifications

Full day course
•  Food Standards

For more information visit the RFA website

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