The Essential Technical & Regulatory E-News - Local & International - July 2002

TGA News

¨ TGA Fees & Charges

As of July 1st, new TGA fees and charges apply. Listing applications new fee is $460 per application and $390 per annual fee and $220 per variation.

See new fees and charges:

See accompanying notes for new fees:

¨ Press Release - HRT Research

The Hon Trish Worth MP Parliamentary Secretary to the Minster for Health & Ageing released a press statement on July 11th - “An Australian expert committee, convened by the TGA yesterday to evaluate a just released US study that cast doubts on the safety of combination HRT, has recommended combination HRT to manage symptoms of menopause is still an appropriate treatment option” – for short term use.

¨ A Review of Advertising Arrangements for Therapeutic Goods in Australia and New Zealand

A Review of Advertising Arrangements for Therapeutic Goods in Australia and New Zealand is being undertaken to develop an advertising approval and complaints scheme that can be implemented as part of a trans-Tasman therapeutic goods agency. The review will build on recent work to simplify the current Australian advertising arrangements. It seems likely a simplified system similar to operating in New Zealand may be adopted for both countries.

¨ Advertising Information on the Internet

The TGA Internet site has been updated to include:

* Advertising therapeutic goods to consumers

* How to lodge complaints about advertisements for therapeutic goods

* Schedule 1 certificates

* Gazettal notices relating to advertisements.

¨ Trans Tasman Harmonisation

The final decision on whether to proceed with the establishment of a joint agency is expected by the Australian and New Zealand Governments in the second half of 2002. If a joint agency is to be established, work will proceed on developing new legislation to be introduced to Parliaments in 2003. The earliest date for commencement of a joint scheme is expected to be mid-2004.

¨ CMEC – New Appointments

Professor Tony Smith has been appointed as the new Chair of CMEC (Complementary Medicines Evaluation Committee) until April 2005. Professor Smith was Foundation Professor and is now Emeritus Professor of Clinical Pharmacology, University of Newcastle.

The current membership of CMEC and its Panel of Expert Advisers is due to expire soon. New membership is currently under consideration by the Parliamentary Secretary and it is expected that the new appointments will be announced shortly.



On 12th July 2002, the following product was issued a Class II Consumer Recall:

¨ Difflam Mouth Gel 10gram tube (3M Pharmaceuticals Pty Ltd)

Reason: Possible microbial contamination in some tubes.
[Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]

Diet and Criminal Behaviour EXCLUSIVE

A new study has found that adding vitamins, minerals and other nutritional elements to the diets of young offenders remarkably reduced their antisocial behaviour. According to the prominent researcher Alex Schauss this is not new. Dr Schauss has taken the time to write his comments exclusively for our newsletter – click here to take you to his story.

International News

American Medical Journal Announces Adults Should Take Vitamins
In a landmark article published June 19, 2002, The Journal of The American Medical Association (JAMA), announced that all adults should take vitamin supplements to help prevent chronic diseases.

New Labelling Laws in USA for Ginseng products

The American Herbal Products Association released an update stating that a new Bill limits the use of the name “ginseng” to the genus Panax only. In other words Eleutherococcus senticosus must be called "eleuthero." - in the US it is now illegal to call it "Siberian ginseng." In addition, the new law appears to prohibit the use of a statement like “also known as [xxx] ginseng” for any non-Panax plant in advertising and labelling.

Overview of Nutrient Studies by CRN

The Council for Responsible Nutrition (CRN) has released a 100-plus page report of studies that link consumption of multivitamins, antioxidants, minerals and fatty acids to preventing diseases.


Conferences and Meetings 2002

¨ NHAA Women in Health Seminar

Seminar includes information on HRT, endometriosis, herbal medicines for menopause, and the oral contraceptive pill – safety and herbal interactions.

August 11 – Brisbane

October 19 – Sydney

Contact [email protected] or phone (02) 9560 7077

¨ Interact 2002

(Drug analytical issues covering ethical, OTC and emerging biotechnology products)

July 21 – 25, University of Technology Sydney (UTS)

¨ Great Southern Guild Pharmacy Fair - Victoria

July 20 – 22, New Grandstand, Flemington Racecourse. Contact (03) 9810 9999

¨ Western Australia Pharmacy Fair

July 27-29, Burswood Convention Centre Contact (08) 9324 2355

¨ New Code of GMP – seminars

August 28, Australian Technology Park, Sydney, 1.00pm – 6.00pm

(Jointly arranged by ASMI, RACI and APMA)

Contact ASMI Secretariat 02 9923 9417 or email [email protected]

September 2, Brisbane (jointly arranged by ASCC and ISPE)

September 5, Melbourne (jointly arranged by (PDA and ISPE)

¨ ASMI Conference

On the Level: A New Balance for Consumer Healthcare Products”

September 12, Le Montage, Frazier St, Leichhardt, Sydney

¨ National Herbal Medicine Week

September 16 – 22 Contact [email protected] for further details

¨ First Asia Conference on Dietary Supplements (IADSA)

September 24-25, Bangkok, Thailand

¨ Natural Healthcare Conference 2002

September 28 – 30, Sydney Convention & Exhibition Centre, Darling Harbour, Sydney

Contact – Event Managers phone – (02) 9299 9673

¨ Natural Healthcare Expo 2002 (previously named CHC Expo)

September 29 – 30, Sydney Convention & Exhibition Centre, Darling Harbour, Sydney

Phone – (02) 9290 1234 or (03) 9530 2500

¨ Pharmacy Australia Congress 2002, Hobart

October 18 – 20, Wrest Point, Hobart, Tas Contact (03) 9903 9585

¨ The Natural Health Fair 2002

November 13-15, Hong Kong Convention & Exhibition Centre

Asia’s International trade event.

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