AU: The Essential Technical & Regulatory E-News - Local & International May 2002

New Substances (for listed medicines)

CMEC has recommended the following be permitted as active ingredients in listed complementary medicines:

  • Synthetic crystalline zeaxanthin (subject to resolution with TGA of stability issues)
  • L-Arginine (topical application only not for mucosal, vaginal or rectal use)

CMEC recommended the following is NOT suitable for use in listed medicines:

  • Red yeast rice (safety reasons)

TGA News

Label Requirements for Caffeine-Containing Herbs
CMEC has recommended to the TGA that labels on products with caffeine containing herbs should declare a) that the goods contain caffeine and b) the total quantity of caffeine per dosage unit. Homoeopathic medicines more dilute than 1X (mother tinctures) are exempt from this requirement.

Review of Labelling Requirements
In March 2002, TGA produced a consultation report: Review of the Labelling Requirements for Medicines – Consumer-focussed Labelling – A Way Forward? With the intention being to introduce a new Labelling Order with phasing out of TGO 48 in July 2004.Consultation with major stakeholders will take place in the third quarter 2002. You will be able to gain a copy of the report from the TGA website shortly.

Child Resistant Packaging
The Therapeutic Goods Committee is working towards a Therapeutic Goods order for specifying standards for child resistant packaging of therapeutic goods.
See A Message from ASMI for further information.

Orphan Drug Program Review
An independent report has been conducted on the Australian Orphan Drug Program – the report is open for consultation until June 22nd.

Draft Compositional Guidelines
Draft compositional guidelines are intended to clarify a TGA approved listed medicine, where there is no BP standard or other acceptable monographs. Guidelines are now available for: bovine derived chondroitin sulfate; shark cartilage derived chondroitin sulfate; sugar cane wax alcohols; conifer phytosterol complex; black-boned chicken powder; demineralised fish proteoglycan extract; SAMe.

Salvia divinorum - Schedule 9 Poison
Salvia divinorum, a member of the sage family will be included as a schedule 9 poison from June 1 this year. The herb has psychoactive properties. The move comes after the herb which is not approved for use in Australia has being imported for recreational use. Schedule 9 Poisons are drugs of abuse, the manufacture, possession, sale or use is prohibited by law. (except in amounts which may be necessary for medical or scientific research conducted with prior approval)

Advertising Fact Sheets
New fact sheets available from TGA.
1. Points for medical practitioners to consider when advertising services that involve products containing Schedule 3, 4 or 8 substances. Some practitioners are promoting products such as collagen and botox injections. TGA recommends using wording such as “cosmetic injections” or “anti-wrinkle injections” so as not to contravene the regulations.
2. Regulation of Therapeutic goods in Australia – includes approval process and complaints handling procedure flow charts.
To contact the advertising unit [email protected]

New GMP Guide for Medicinal Products
The Therapeutic Goods Committee has recommended that the Australian code of GMP be revoked and the PIC/S (Pharmaceutical Inspection Co-operation Scheme) system adopted. A 12-month transition period will apply from the commencement date of the new Manufacturing Principle.


On 29th April 2002, the following product was issued a Class II Consumer Recall:
Voyager, Columbus & Traveller 3 & 4 Wheeled Mobility Scooters (Fisher & Paykel Healthcare Pty Ltd )
A limited number of scooters may experience premature failure of the drive mechanism. In the event of failure loss of drive and braking occurs.
[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.]

Sponsor Responsibilities – Advertising of Listed Products
A sponsor has a responsibility to ensure that they do not by any means intentionally or recklessly advertise a listed medicine for an indication other than those that are included on the Register. Whilst the advertising code has recently been revised, evidence to support claims is now required. Only approved indications for listed therapeutic products can be advertised. Any mandatory statements that are required must also appear on the advertisement.
If shelf talkers, posters, leaflets, shelf wobblers contain therapeutic claims the mandatory statements are required to appear on these items.
For a copy of the Therapeutic Goods Advertising Code

St Johns Wort & Chemotherapy Drugs
According to new research presented at the 93rd annual meeting of the American Association for Cancer Research, St Johns Wort may reduce the efficacy of a chemotherapy drug, even up to three weeks after ceasing herbal therapy.

EMEA Guidelines on Irritable Bowel Syndrome Trials

The European Agency for the Evaluation of Medicinal Products has issued a draft consultation paper on guidelines for the evaluation of medicinal products for Irritable Bowel Syndrome.

WHO Herbal Monographs Available – FREE
Volume 1 of the WHO (World Health Organisation) Monographs on selected medicinal plants is available to download from the WHO website. There is no charge for the monographs.

Australian Study on Natural Remedies for Children
A study by clinical research fellow Dr Alissa Lim from the Royal Children’s Hospital in Melbourne was presented at a recent Royal Australasian college of Physicians annual scientific meeting. The study reported children are at risk of serious side effects from popular complementary medicines such as ginkgo, ginseng, and echinacea. The national survey found 16 incidents (in a 12 month period) where adverse events from using these treatments ranged from mild to fatal.

Top Ten OTC Categories in Australian Retail Pharmacy 2002

According to a report in Pharmacy News the top ten categories in retail pharmacy and the % value growth over previous year were:

1. Non narcotic analgesics 7.1%
2. Antihistamines systemic 19.7%
3. Anti-smoking products 4.1%
4. Cold preparations 10.1%
5. Systemic nasal preparations 13.2%
6. Emollients and protectives 12.6%
7. Infant formulas 6.1%
8. Laxatives 12.2%
9. Antifungals dermatological 0.1%
10. Multivitamins & minerals 12.2%
11. Others 0%

As at February 2002 – IMS figures state the total number of active pharmacies in Australia as 4,921.

International News

Current Annual Economic Growth Rate – Britain = 1.7%, USA = 0.4% and Australia = 4.1% (source: John Croucher, Prof Statistics, Macquarie University)

Canada’s Natural Health Products Directorate – new regulatory text published by Health Canada last year will become law in the 1st half 2002. There is a two year transition period for products already on the market to comply.

The New Zealand Commerce Commission, as part of a world-wide sweep, found 53 medical websites operating in the .nz name space making false or misleading claims about the therapeutic value of goods sold online. Under New Zealand regulatory practices, product advertising bearing health benefit claims must first be registered as a medicine. A total of 1400 sites worldwide were identified as suspicious. Warning letters were distributed.

Germany is set to reclassify kava as a prescription-only drug following a recommendation by the country's top government health agency to the German Health Ministry.

The FDA will allow a qualified health claim, about EPA and DHA omega-3 fatty acids in dietary supplements and reduced risk of coronary heart disease (CHD). The qualified health claim states: "The scientific evidence may in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD.” Reducing the risk of coronary heart disease (CHD) is suggestive, but not conclusive.

Conferences and Meetings 2002

Business Opportunities
The Heritage Store Inc in Vancouver is seeking an Australian Distributor for their Edgar Cayce health and beauty products (including oils, shampoos, mouthwashes, toothpowders, gum treatments). Should you be interested please contact David Riblet at [email protected]

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