The Essential Technical & Regulatory E-News Sept, 2002

New Substances

CMEC has recommended that the following is suitable for use as an active ingredient in listable therapeutic goods: Magnesium phosphate dibasic trihydrate


TGA News

CMEC Recommendations – Meeting 35 & 36 – expanded notes

Red Yeast Rice was previously not recommended for listing due to safety reasons. Committee members noted that not all extracts of red yeast rice were evaluated - the substance evaluated was a specific extract, prepared in a non-traditional manner, and it contained a higher level of lovastatin than would be expected in a traditional preparation. Members agreed that the minutes of meeting 34 should be changed to indicate that the decision did not relate to all red yeast rice substances.

Both Chlorella pyrenoidosa and Spirulina maxima are currently eligible for inclusion in listed complementary medicines only as non-active (excipient) ingredients. The TGA Office of Complementary Medicines has recommended that, subject to further discussion, these two ingredients be eligible for inclusion as active ingredients in listed medicines.

Medical Device Regulatory Change

Recent amendments to the Therapeutic Goods Regulations included changes relating to devices of human or animal origin. The insertion of “bacterial or recombinant origin” ensures all biological devices included in this clause require evaluation for both safety and efficacy. The change affects listable medical device products incorporating bacterial or recombinant substances.

Current Status of Australian codes of GMP

The TGA has set out the various manufacturing standards, specified in the Therapeutic Goods Act 1989 as Manufacturing Principles, for different categories of therapeutic goods regulated by TGA effective August 2002.

Compositional Guidelines

The TGA has prepared compositional guidelines (CG) for the following ingredients in complementary medicines (follow link to TGA web page):

More information at

GMP For Starting Materials

Therapeutic Goods Manufacturing Principles Determination 2 available at:

New Code of GMP Seminar Notes

If you were unable to make the August GMP seminars – notes are available to download at

The new Australian Code of GMP for Medicinal Products can be downloaded from

Enterprise Details Form Replaced

A new “Client Details Form” has been introduced to replace the “Enterprise Details Form”. This should be completed by or for each sponsor involved with the supply of the therapeutic goods in Australia. All clients of Robert Forbes & Associates will receive a partly completed form from us, no need to download from TGA.



On 17th September the following products were issued Class II Recalls due to the recovery of “wrongly supplied” goods pursuant to Section 30 Therapeutic Goods Act 1989:

Kava 1800 Plus tablets (Eagle Pharmaceuticals)

Passionflower 220 Plus tablets (Eagle Pharmaceuticals)

Calmo Drops (Eagle Pharmaceuticals)

The issue with the above is that the products were labelled as containing as an active ingredient, the herb skullcap. However, testing by the TGA Laboratories revealed that the ingredient contained was not skullcap (Scutellaria lateriflora). This problem was identified during investigations into the death of an Australian person taking a product containing kava kava.

On 17th September the following product was issued a Class II Recall due to the possible microbial contamination in some bottles: Difflam C Alcohol Free Solution, 100mL (3M Pharmaceuticals Pty Ltd)

[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.]

Kava Update

Last month the TGA issued a voluntary recall of all complementary medicines containing the herb kava. The recall was in response to a fatal adverse event in a 56 year old woman. The Kava medicine implicated in this event also claimed to contain Passiflora incarnata (passion flower), and Scutellaria lateriflora (skullcap). Testing by TGA has confirmed the presence of kava and Passiflora, but Scutellaria lateriflora was not detected. To date, the identity of the third ingredient has not been established. The TGA continues to investigate this apparent breakdown in GMP and QA procedures.


Trans Tasman - New Inquiry Agreed

The New Zealand Government Health Select Committee’s Chairwoman, Steve Chadwick, has announced an inquiry into the establishment of a Trans Tasman agency to regulate therapeutic products. Mrs Chadwick said that community concerns had led to the decision for the inquiry.


New Food Standards Become Mandatory on 20 December

The Australia New Zealand Food Standards Code comes into force as the only food standards for Australia and New Zealand on 20th December. This date will also see the repeal of the old Australian Food Standards Code and the New Zealand Food Regulations. All food produced in both countries from that date must comply with the new Standards. The new code introduces:

§ Mandatory nutrition labelling, with few exemptions.

§ Mandatary labelling of certain foods and additives that are recognised to cause severe adverse reactions in some people, even where the food is exempt from ingredient labelling.

§ Percentage labelling of characterising ingredient or components, for example the amount of cocoa solids in chocolate

Other labelling requirements remain essentially the same as in the old Australian Food Standards Code and New Zealand Food Regulations. This ends the two year period where the old and new Standards have been running in parallel and in New Zealand both these plus the Food Regulations have been alternatives for food manufacturers and importers. Transitional arrangements allow food produced before 20th December and compliant with one of the repealed laws to be sold for a period of up to 2 years for products with a shelf-life of one year or more, and up to one year for products with a shelf-life of less than one year.

The new standards can be found at A reliable update service on paper and on CD is available from Food Liaison Pty Ltd:


Australian Natural Therapy Industry Study

The Sydney Morning Herald (17.09.02), reported on a recent study by Dr MacLennan published in the Preventative Medicine Journal. The study was conducted by Adelaide University and showed 60% of women and 44% of men now use alternative therapies. The report stated that Australians spend four times more on alternative therapies than they do on pharmaceuticals. In total it was estimated that Australians spent $2.3 billion on alternative medicine and therapies in 2000, more than twice what was spent in 1993.

It found alternative medicine users were more likely to be female, Australian born, of higher socio-economic status, better educated, single and employed. They were less likely to have diabetes, high blood pressure or cholesterol levels.


Amendments to Therapeutic Goods Advertising Code

Amendments to the code include the following clarifications:

· who is the “sponsor” of research

· meaning of “prohibited representation” and addition of HCV (hepatitis C virus) to the list of prohibitions

· clarity/size/readability etc of warning statements

· weight management claims must include reference to lifestyle changes such as diet and exercise

· some appeal processes

· acne preparations and unscheduled anti-dandruff preparations added to the list of goods that may be advertised to minors

Full details at


Conferences and Meetings 2002

National Herbal Medicine Week

September 16 – 22 Contact mailto:[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)95302500

Adoption of PIC/S GMP Guidelines Workshop

1 – 2 October, Holiday Inn, Potts Point, Sydney; Register online at or phone the CHC on 02 6260 4122 for further details

Importing/Exporting Restricted Substances (TGA Information Seminar)

2 October 2002, Edmund Barton Building, Barton ACT; Ms Sharyn McGregor, Phone 02 6270 4384, Email [email protected]

Pharmacy Australia Congress 2002, Hobart

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

NHAA Women in Health Seminar

Seminar includes information on HRT, endometriosis, herbal medicines for menopause, and the oral contraceptive pill – safety and herbal interactions. October 19 – Sydney; Contact mailto:[email protected] or phone (02) 95607077

New Code of GMP – seminars

Late October, Perth, Diana Barron ([email protected])

Evidence based Herbal Medicines: >From tradition to clinic

6th HMREC Annual Symposium (Herbal Medicines Research & education Center – University of Sydney) - 1 November, 12.30 – 6.30pm

Pharmacovigilance - the Study of Adverse Drug Reactions

4 – 15 November, Canberra

The Natural Health Fair 2002

November 13-15, Hong Kong Convention&Exhibition Centre; Asia’s International trade event.

Pharmaceutical Science Beyond the Genome: Harnessing the Potential

8 – 11 December, Carlton Crest Hotel, Melbourne;


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Robert Forbes & Associates Pty Ltd

Regulatory Affairs & GMP Consultants

Phone: 61 2 96608027 - Fax:612 96608106

Postal: PO Box 123, Annandale NSW 2038 Australia

Office: Level 1, 335 -341Glebe Point Road (corner Ferry Rd), Glebe, SYDNEY, NSW AUSTRALIA

Copyright © 2002Robert Forbes & Associates Pty Ltd. All rights reserved.

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