Jan. 2003 - The Essential Technical & Regulatory E-News - Local & International

Happy New Year

From all the team at Robert Forbes and Associates, we would like to wish you an exciting and successful 2003!


Overview "Health Claims & Consumer Protection Advisory Committee"

The NSW Government recently announced it plans to set up a Health Claims & Consumer Protection Advisory Committee. The press release from the Health Minister's Office stated that the Committee will review the existing laws and regulations available to stop health professionals making false health claims, selling untested or unproven health products or conducting potentially unsafe procedures. It aims to bolster the powers of the health professional boards eg NSW Medical Board to deal with fraudulent practitioners, as well as increase the penalties for marketing spurious health products. Professor John Dwyer, Associate Dean of Medicine at Sydney's Prince of Wales Hospital was appointed Chair of the Committee. The Media Release from the Health Minister can be found at http://www.health.nsw.gov.au/health-public-affairs/mediareleases/2002/October/31-10-02.htm

Key members of the Complementary Health Industry immediately raised concern about the setting up of this Committee. Whilst, the Minister for Health Craig Knowles and Professor John Dwyer both stated up front that this "is not a witch hunt" and that those practitioners who offered proven products and services should not be concerned, key complementary health members still questioned the motive behind this committee. They were concerned that this Committee was set up without consultation with industry and that the Committee and the Chairman lack the necessary expertise in the field of complementary medicine to make judgments on the science and value of CAM products or services.

As a result of the formation of this controversial Committee, the Natural Health Alliance was set up - whilst coordinated by the CHC, the Alliance represents complementary health industry, practitioners and other interested parties. The Natural Health Alliance and the CHC has worked closely with the NSW Health Department to achieve the following:

  • Agreement that there will be equal representation of orthodox and complementary health practitioners on the Committee
  • Agreement that the Committee will deal with both orthodox and complementary medicine issues
  • Expressed the need for a meeting with the Minister of Health to discuss their continuing concerns about the need for an Independent Chairman.

The Current Affairs Newsletter contacted Professor John Dwyer for comment and at the time of publication no comment had been received.


TGA News

Supplementary Requirements for Therapeutic Goods to Minimise the Risk of TSE

TGA has released a document on the management of TSE risks associated with putatively "low-risk" ingredients currently listed in Category IV of the EMEA Guidelines. The document outlines a self-assessment process whereby sponsors of therapeutic goods can collate information necessary to certify compliance with the TGA requirements. The TGA intends the formal implementation date for self-certification of compliance to be no later than 30 June 2003. The TGA will hold workshops to assist sponsors with implementation of the new requirements. The first such workshop will be with industry peak bodies on 7 February 2003.

Robert Forbes and Associates will review all new submissions to ensure they meet with the additional requirements for minimizing TSE risk.

Q & A on New Australian Code of GMP

Version 4 of the Q & A on the New Australian code of GMP was issued December 2002.. The document available for download covers Quality Management, Personnel, Premises & Equipment; documentation, QC, Manufacture, Sampling, Computerised systems, Ionizing Radiation, Auditing & Licencing, Imports and Wholesaling.

Australian Guidelines for Registration of Drugs Volume 2

Recently released Supplement 4 - Efficacy & Safety of OTC Medicines replaces Chapters 9 & 10 of AGRD2. Once all revisions are made to AGRD2 a new publication will be available - Australian Guidelines for the Registration of OTC Medicines (AGRM)

Summary of Bioavailability or Bioequivalence Studies
New forms are available for submitting a summary of a bioavailability or bioequivalence study.

CMEC - November 2002 Meeting
CMEC endorsed the current regulatory status prohibiting the use of medicines containing Aristolochia spp. and aristolochic acids.

In addition CMEC recommended maintaining Larrea tridentata (chaparral) as a listable substance, but with a revised warning statement for oral products

Guidelines for Australian Medical Devices
A series of guidance documents have been produced to help explain the new regulatory system for medical devices in Australia (effective 4 Oct 02).

Guidance document Number 3 is available and outlines obligations on manufacturers for the manufacture of medical devices for supply in Australia. These are known as the conformity assessment procedures.

Guidance document Number 4 is available and is intended as a guide to the requirements for clinical evidence needed to support an application for the inclusion of a medical device on the Australian Register of Therapeutic Goods.




New Food Labelling Laws

On 20 December 2003, the Australia New Zealand Food Standards Code became the sole Food Standards Code for both countries. The Australia New Zealand Food Standards Code(the new Code) came into effect in December 2000, with a two-year transition period ending on 20 December 2002. Provisions have been introduced into the new Code to allow foods manufactured and packaged before 20 December 2002 ('stock-in-trade') to continue to be sold legally after this date, as long as they comply with the requirements set out in the old regulations with some conditions.

The code requires comprehensive labelling on most foods including nutrition information panels detailing the amount of energy (kilojoules), protein, total fat, saturated fat, total carbohydrates, sugars and sodium. Manufacturers also are required to identify whether products contain items to which some people are allergic, like nuts, seafood, milk, gluten, eggs and soybeans.

Electronic versions of the Australia New Zealand Food Standards Code, user guides and fact sheets can be obtained from the FSANZ website at www.foodstandards.gov.au or www.foodstandards.govt.nz.


Amendment 64 to Food Standards Code

The amendment 64 published 13th December contained amendments relating to:

A445 - Ethylene Oxide
A461 - Maximum Residue Limits
P154 - Regulatory requirements for foods comprising or containing Royal Jelly, Bee Pollen and Propolis, including the need for label warning statements
P263 - Safety Assessment of Raw Milk Very Hard Cooked-curd Cheeses
P267 - Amendments for the Labelling of Home Brew Kits
P268 - Amendments for The Transitional Arrangements for Labelling Milk
P269 - A Transitional Standard for Caffeine in Artificial Drinks (New Zealand only)
P270 - Amendments to Standard 2.9.2 - Foods for Infants: Electrolytic Iron as a Permitted Form of Iron; and Clarification of 'Juice'
Copy of the amendment is available at Food Standards Australia New Zealand


Shark Cartilage Draft Monograph

Shark cartilage is the second supplement to receive a draft monograph from the Institute of Medicine (IOM). In reviewing the literature on the ingredient's adverse events, IOM reported that the variances in product preparations might be the biggest health concern. Draft monograph click here.


Innovative Food Centre Launched

A joint venture between the CSIRO and Australian Food Industry Science Centre saw the opening of the Innovative Foods Centre in Werribee Victoria. The Research Centre will focus on the latest minimal and non-thermal technologies to produce safer, more nutritious foods. These technologies inactivate food microbes such as yeasts, bacteria and moulds to produce food products that are free of additives, retain their fresh taste and have extended shelf life.


New University Postgraduate Complementary Medicine Course For Pharmacists

A new postgraduate program, aimed at helping pharmacists take advantage of the growing complementary medicine market, will be available in 2003.

The Graduate Certificate in Complementary Medicine (Pharmacy) is a one-year part-time program, offered by two of Australia's leading universities in the fields of contemporary and complementary medicine. The University of Queensland and Southern Cross University have responded to the increasingly important influence of contemporary medicine in Australia with the establishment of the Australian Centre for Complementary Medicine Education and Research (ACCMER). ACCMER's debut program aims to offer pharmacists a professional edge in this emerging market. The program is offered online, with no class attendance required. For more information contact ACCMER on (07) 3840 6117.


Developing new Australian plant products - partners required

Coradji, a company which researches and develops new products based on Australian plants, is looking for partners in developing products based on one or more of the following:

  • a coastal shrub with potential cosmetic uses
  • two different inland bushes with possible arthritis application (one of these currently undergoing PhD research)
  • a coastal tree with an aromatic oil traditionally used to relieve colds and flu

If you are interested in any of the products described above, please email [email protected]

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.