Issue 91 - May 2009
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

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• RFA News
• Medicines
     • Consumer Advice
     • TGA news
• Foods
     • FSANZ update
• Association news
• Conferences and meetings
• RFA training courses

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RFA news

RFA sets up regional office
RFA is pleased to announce we have now opened an office on the Gold Coast. For enquiries relating to Queensland state based trainings, meetings and advice please continue to contact the Sydney office and we will be able to assign the calls.
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Consumer Advice

Advice to consumers regarding hydroxycut products
The TGA is aware that the US Food and Drug Administration (FDA) has issued a warning to consumers in the US to cease using hydroxycut products because of reports of a number of serious adverse reactions, including liver toxicity. To date, the TGA has received no reports of adverse reactions similar to those reported in the US. However until the TGA has completed a safety audit of these products, consumers are advised to exercise caution when using Australian hydroxycut products.
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TGA news

European Union guidelines proposed for adoption
EU guidelines have been recommended for adoption or non-adoption by the TGA. Closing date for comment is 27 May or 15 June depending on the guideline.
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NDPSC pre-meeting notice
The National Drugs and Poisons Schedule Committee (NDPSC) pre-June scheduling notice, included among substances to be considered for scheduling:
Piper methysticum (Kava) including a proposal to exempt the dried root or rhizome from scheduling
-    Magnesium sulfate including a proposal to include magnesium sulfate in Schedule 3 for human therapeutic use in divided oral preparations for constipation
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Cancellation of a therapeutic good at sponsor request
An annual charge for the current financial year remains payable following the cancellation of an entry of a therapeutic good entered on the ARTG by a sponsor. Annual charges invoices for the 2009/10 financial year will be sent to sponsors early in July 2009. These invoices will cover all products entered on the ARTG as at 1 July 2009. If a cancellation request is not received by the TGA before 1 July 2009 then the sponsor will be liable for the 2009/10 annual charge.
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Technical working groups
Technical Working Groups (TWG) have been established by the TGA's Office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise from industry and the regulator to address the grey areas of the cGMP as it relates to manufacturing. TWGs include; Blood Tissue & Cellular Therapy TWG; Complementary Medicine TWG; Non-Sterile Medicine TWG; Pharmacy Manufacturing TWG; Sterile Medicine TWG.
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TGA extends shelf life of oseltamivir (Tamiflu®)
The TGA has approved an extension to the shelf life for Tamiflu® (oseltamivir) from five to seven years, when stored below 25°C. The approval was based on the submission of data by the product's sponsor demonstrating adequate safety, efficacy and stability of the medicine, when stored under appropriate conditions, for a further two years beyond the original expiry date.
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Advice from TGA on human papillomavirus vaccine (GARDASIL)
The TGA has issued advice on the Gardasil vaccine that protects young women from the strains of human papillomavirus (HPV) that cause 70 per cent of cervical cancers. Around 4.7 million doses of Gardasil have been distributed in Australia and to date the number of suspected adverse events following Gardasil administration is low. The TGA has assessed Gardasil as safe and effective.
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Guidance document on sampling and testing of complementary medicines products and raw materials
The guidance document is intended to clarify the interpretation of the Australian Code of GMP for Medicinal Products in relation to the sampling and testing of complementary medicines. It covers the sampling and testing requirements for raw materials used in the manufacture of complementary medicines and complementary medicines, whether in the form of intermediate, bulk or finished products. It also describes a plan for reduced sampling and testing once an approved supplier has been qualified.
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Bill on multiple default pharmacopoeias passes Senate
The Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 containing the amendments to the Act to allow multiple default pharmacopoeias as equal standards was passed by the Senate without amendment. The amendments add the European and US Pharmacopoeias as default standards and allow manufacturers to adopt the relevant pharmacopoeia as soon as it comes into effect in the country of origin. It will be considered by the House of Representatives in the Budget sittings. The commencement date is 1 July 2009.
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Definition of British Pharmacopoeia
The Federal Register of Legislative Instruments specifies that the definition of British Pharmacopoeia in subsection 3(1) of the Therapeutic Goods Act will as of 1 June 2009 be the British Pharmacopoeia 2009.
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TGA news 58
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European Union guidelines (updated)
EU guidelines recommended for adoption or non-adoption.
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FSANZ (Food Standards Australia New Zealand) update

Human swine influenza and food
There is no evidence to suggest that H1N1 Influenza 09 (human swine influenza) can be transmitted to people through eating pork products. Swine Influenza has never been reported or detected in pigs in Australia.
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Joint communiqué from Ministerial Council
The thirteenth meeting of the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) was held in Sydney. The Ministerial Council considered a number of strategic policy and food standards issues:
agreed to the terms of reference for an independent, comprehensive review of food labelling law and policy
-    noted that the stakeholder consultation on the development of a policy guideline for front of pack labelling (FOPL) is complete
-    considered a report on alcohol warning labels and agreed to provide this report to the Ministerial Council on Drug Strategy to allow a single and coordinated response to COAG as a part of its broad and comprehensive approach to reducing binge drinking
-    received a progress report on dietary modelling activities in relation to trans fatty acid intakes in the Australian and New Zealand food supplies, a review of recent scientific literature regarding the link between dietary intake of trans fatty acids and adverse health outcomes and a report on the progress of voluntary initiatives by industry to reduce trans fatty acids in the food supply. Final report expected in October 2009.
-   negotiations to amend the joint Food Standards Treaty are progressing
-   agreed to review FSANZ Proposal P290 Food Safety Programs for Catering Operations
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Budget 2009-2010
In the 2009 Australian Federal Budget, it was announced that Food Standards Australia New Zealand would receive $2.853 million to upgrade the data management and modelling systems to a modern database platform. Developing the new system and transferring the existing data across is expected to take two years to complete, the new system is expected to be operational in July 2011.
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Food Standards Gazette No107
Amendment No107 was gazetted on 30 April 2009 in Australia and published in the New Zealand Gazette on the same day. The Application and Proposal under which these amendments are made are; Application A1004 - Phospholipase A2 as a Processing Aid (Enzyme); and Proposal P1002 - Hydrocyanic Acid in Ready-to-Eat Cassava Chips.
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Food Surveillance News Autumn 09
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Joint press release

'Swine flu' products
The Complementary Healthcare Council (CHC) and the Australian Self Medication Industry (ASMI) are warning consumers to stay away from complementary medicines or medications that claim to treat or prevent swine flu.
The two industry associations have collaborated to issue a joint warning against such products, and to urge their member companies to refuse to stock or sell them. The public should be wary of internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus that have not been proven to be safe and effective for these uses by the TGA. Many of these deceptive products are being sold over the internet via illegitimate web sites. The operators of these web sites take advantage of the public's concerns about H1N1 influenza and their desire to protect themselves and their families. These fraudulent products can present as supplements, food products, or products purporting to be drugs, devices or vaccines. There are a number of over-the-counter and complementary medicines that can assist consumers with maintaining their health and concerned consumers are advised to consult a healthcare professional for advice. Consumers aware of fraudulent products should advise the Therapeutic Goods Administration.

Complementary Healthcare Council of Australia (CHC)

'Adulterated' ginkgo products
The CHC is seeking comment regarding a TGA proposal to impose an additional condition of listing to products containing Ginkgo biloba extracts as an active ingredient. This has come about due to claims that rutin and quercetin had been added to some Ginkgo biloba raw materials sourced from China. In response, the Office of Complementary Medicines (OCM) commenced an investigation into the use of Ginkgo biloba extracts in medicines included in the ARTG. Their investigation revealed that approximately one third of the products tested contained flavonoid compounds indicative of Ginkgo biloba (rutin, quercetin, kaempferol and isorhamnetin) in ratios that were not consistent with expected chemical profiles.

To address this issue, the OCM is proposing that an additional test (USP Identification Test B) be a condition of listing for all products on the ARTG where Ginkgo biloba extracts are an active ingredient; this is currently being consulted on with industry. The TGA will initiate a submission to the BP Commission to advise of their findings and explore the possibility of the inclusion of a test equivalent to the USP Identification Test B in the monograph 'Ginkgo Dry Extract, Refined and Quantified' in forthcoming editions of the BP.
The information provided by the CHC has been reprinted with permission.

National Herbalists Association (NHAA)

NHAA 2009 seminar series
The changing face of herbal practice with Sue Evans
Melbourne Sat 11 July
Adelaide Sun 12 July
Canberra Sat 1 August
Hobart Sun 2 August
Perth Sat 15 August
Brisbane Sun 20 September
Sydney Sat 10 October

For more details see or phone (02) 8765 0071
NHAA 8 CPE points

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Conferences and meetings

Pharmacy Expo
June 12 14, Darling Harbour Sydney
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Natural Products Expo Asia
August 27 - 29, Hong Kong Convention and Exhibition Centre, Hong Kong
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Natural Health Conference & Expo
September 2 4, AJC Convention Centre, Randwick, Sydney
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Organic Products Expo BioFach America
September 24 26, Boston, (MA) USA
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Natural Products Expo East
September 23 26, Boston Convention & Exhibition Centre, Boston, MA, USA
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ASMI Annual Conference & AGM
November 12, Australian Technology Park, Redfern Sydney
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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

Robert Forbes & Associates regularly conducts training courses for clients in our Glebe office meeting room. Courses are conducted with up to five people from only one client at a time. Courses can be tailored to suit your needs, based on your product types and to address any regulatory issues you may be facing.

Half day (4 hour) courses
   • Overview of the Food/therapeutic/cosmetic interface
   • Cosmetic regulation
   • Advertising code
   • Researching levels of evidence for product claims and indications
   • TGA online applications
   • Finished product specifications

Full day courses
   • Food Standards

For more information visit the RFA website

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Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants
Phone: 61 2 96608027 - Fax: 612 96608106 Postal: PO Box 123, Annandale NSW 2038 AUSTRALIA
Office: 335 -341 Glebe Point Road (Entrance Ferry Rd - Level 1), Glebe SYDNEY, NSW AUSTRALIA

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