TGA News

PIC/S Notes for Industry on Site Master File Preparation

A Site Master File is prepared by a manufacturer to provide specific information about the production and control of manufacturing operations. Effective November 5 2002, the Guidelines for the Preparation of a Site Master File (1st Ed April 02) has been replaced by the PIC/S Explanatory Notes for Industry on the Preparation of a Site Master File (1 Nov 02). http://www.health.gov.au/tga/docs/html/siteinfo.htm

ARTG and DEAL now online
If you are a Sponsor or an Agent of a Sponsor of a therapeutic good, you can now view your Australian Register of Therapeutic Goods (ARTG) records online via the Internet.

As mentioned in the previous issue of Current Affairs, applications for medical devices under the new legislation can also be done online.

If you have not received a letter explaining how to gain access to the online systems contact the SIME Help Desk by email at tga.sime@health.gov.au

TGA Legislation Update
A number of changes to the TGA legislation have been made since July 2002 - see TGA website http://www.health.gov.au/tga/docs/html/legisch.htm

New Regulatory Framework for In Vitro Diagnostic Devices (IVDs)
IVD regulatory requirements were introduced into Australia in 1991 and they now require updating in order to bring them in line with international standards and advances in IVD technology. Development of a new IVD regulatory system has commenced that is aligned with international best practice, including the principles espoused by the Global Harmonization Task Force (GHTF). The GHTF is an international forum of medical device regulators and industry associations and its goal is to develop harmonised principles relating to medical device regulation. A Discussion Paper for consultation will soon be available on the TGA website at: http://www.health.gov.au/tga/devices/devices.htm.

NCCTG Working Group - Reusable Surgical Instruments
Following the recalls of 2 orthopaedic instruments due to them containing residual biological materials (which were not removed by normal infection control procedures), the TGA is establishing an Expert Working Group to examine public health risks associated with some reusable, multi-component surgical devices - whose design may affect their ability to be effectively cleaned and sterilised. The Expert Working Group will operate under the auspices of the National Coordinating Committee on Therapeutic Goods (NCCTG) as the issues impact on both Commonwealth and State and Territory regulatory controls.

Advertising Approval Application Forms
The Advertising Unit of the TGA, in conjunction ASMI and CHC, have developed draft advertising approval application forms for specified and broadcast media. The forms aim to simplify the application for advertisers, streamline the approval process, improve customer service and reduce processing times by standardizing the information required. The forms are being trialled between 1 July 2002 until 29 November 2002. At the end of this trial period, all comments will be considered before a final version is released.

The forms are available electronically from the following websites:

• Therapeutic Goods Advertising Code Council: http://www.tgacc.com.au
• Australian Self Medication Industry: http://www.asmi.com.au
• Complementary Healthcare Council of Australia: http://www.chc.org.au
• Therapeutic Goods Administration: http://www.health.gov.au/tga/docs/html/therad.htm

Identification Testing for Herbal Starting Materials - GMP Audit Focus
Under Australian GMP requirements, manufacturers are advised that it is their responsibility to carry out effective and specific identification testing of herbal starting materials, against authenticated herbal reference materials or equivalent, prior to their use in manufacture. The TGA considers that this will be most effectively done using chromatographic techniques such as TLC or HPLC.

TGA GMP auditors will be focusing on this issue in upcoming audits. Lack of specific identification testing of herbal starting materials together with the absence of authenticated reference materials could constitute a critical nonconformity and may result in further action being taken in relation to the manufacturing licence issued to the company.

Advisory Statements on Labels - Consultation Document
The TGA's Review of the Labelling Requirements for Medicines recommended that warning and advisory statements from various sources (such as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and the Therapeutic Goods Regulations) be consolidated into a single document. The consultation document is open for comment until December 13th .

http://www.health.gov.au/tga/docs/html/labeladv.htm#pdf

Second TGA-Authored Scientific Monograph Published
A second scientific monograph authored by the Chemicals Review and International Harmonisation Section of the TGA has been published by the Organisation for Economic Cooperation and Development (OECD). The Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies, now available on the OECD website ( http://www.oecd.org/ehs ), is intended to assist reviewers in different countries to prepare chemical assessment reports to a consistent level of detail, using a standardised format and methods of scientific interpretation.

Recalls

On 7th November the following product was issued a Class II Recall due to the possibility that one or more Night-time tablets may be incorrectly positioned in the Day-time section of the blister pack:

Orthoxicol Day & Night 24 Cold & Flu Caplets blister pack (Batch 11256 Exp02/03)
(Sponsor - Johnson and Johnson Pacific 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.]

http://www.health.gov.au/tga/docs/html/recalls.htm

Sub Potent Complementary Healthcare Products

In a letter to the Editor of the Medical Journal of Australia (Feb 4 2002) earlier this year, questions were raised as to the content of isoflavone-containing preparations. Ten isoflavone-containing preparations were analysed by an independent reference laboratory in USA. Only 2 products of the 10 had a total isoflavone content close to the stated label amount.

RP Scherer a leading manufacturer stated at the time that independent testing of high profile, highly advertised, branded products is likely to become an issue if Australia follows the trends taking place in the US and Europe. All marketing companies of complementary healthcare products should consider:

• Herbal products contain the stated herb of the correct species and form with the correct active ingredient.
• Where natural vitamin E is claimed that it is in fact used and not blended with a lower priced synthetic vitamin E and represented as all natural vitamin E
• For fish oil containing products that low priced fish oil is not contaminated with heavy metals and/ pesticides. That heavily oxidized fish oils with high peroxide and high anisidine levels will be rancid. Also that correct species of fish oil is claimed.
• The source of gelatin in capsules. The BSE issue in Europe has accelerated a switch from bovine derived to porcine gelatin. Porcine gelatin is indeed banned in some Asian/Muslim countries.

Amendment 63 to Food Standards Code Gazetted

Amendment 63 to the Food Standards Code was gazetted in Australia and New Zealand on 24th October - it included a new wine production standard and the approval of oil and linters from a genetically modified, insect-protected cotton variety as a food. Before GM foods can be approved for sale in Australia and New Zealand, they must undergo a safety assessment by FSANZ. Approval will only be given if the GM food is found to be at least as safe and as wholesome for human consumption as it's conventionally produced counterpart. The approval of the oil and linters from a genetically modified cotton as a food represents approval for sale of the twentieth GM food in Australia and New Zealand.

http://www.foodstandards.gov.au/standardsdevelopment/gazettenotices/amendment6324october1758.cfm

Attack on Black Cohosh

A report in the Medical Journal of Australia (MJA 2002 177 (8): 440-443 - http://www.mja.com.au/public/issues/177_08_211002/whi10119_fm.html), claimed that a patient required urgent liver transplantation after suffering acute hepatitis following the brief use of black cohosh. The National Herbalist Association of Australia states that the authors of the paper provide no verification of the herbal ingredients. Failing to authenticate the plant preparations or review their quality and dosage means that any conclusion is subject to doubt. Secondly, no information was supplied about the woman's past or present medical history, concurrent use of medical or recreational drugs, lifestyle, dietary intake and other factors, which may have influenced her health status. The NHAA also says that, a large body of clinical evidence and research has been accumulated in regard to Black Cohosh and there has been no suggestion to date that the herb is toxic to the liver.

Global Enforcement Action Continues to "Clean Up" the Web

Further to information presented in the previous issue of Current Affairs, the ACCC continues to file court proceedings following a worldwide Internet Sweep (carried out by the International Marketing Supervision Network) for false claims about health products.

After Purple Harmony Plates Pty Ltd failed to comply with Court orders to place corrective statements on their website, the ACCC took the matter back to the Court - who have issued fines for contempt and the ACCC is pursuing ways to ensure the corrective statements are placed on the website.

IMSN members are also taking action based on consumer complaints to www.econsumer.gov. Law enforcement agencies in 17 countries have access to this site.

For more history on sweeps visit http://www.accc.gov.au/ecom2/inter_net_Sweep.htm

IMS Data - Australian and New Zealand Retail Pharmacies up 7%

IMS Data released October 2002 shows that Australian and New Zealand Retail Pharmacies have experienced 7% growth in ethical sales over the 12 months to August 02.

Australians to Eat 'Healthier Chickens'

Australians could soon be eating 'healthier' chickens after the government approved BioPlus 2B, a natural alternative to antibiotic growth promoters for piglets and chickens, it is a probiotic feed additive. Approval for BioPlus 2B was granted by a variety of regulatory bodies including Therapeutic Goods Administration, National Occupational Health and Safety Committee, and Environment Australia.

http://www.foodnavigator.com/news/news.asp?id=6321

Food Industry Warned About %Fat Free Claims

Food Standards Australia New Zealand (FSANZ) have warned food producers and importers that there are two months left to change their food labels to provide the information to consumers which is required under the new Food Standards Code. The deadline for change is 20 December 2002. Any packaged food that does not meet the new requirements and is produced and packaged after that date cannot be legally sold.

Also concerns were made about new food products actively promoting a 93% fat free or even 90% fat free claim - this in fact means these products are 7% or 10% fat respectively, which is not a low fat product. The Code of Practice on Nutrient Claims, which is administered by the food industry, only allows for 97% and above fat free claims, which means the product must be no more than 3% fat. More information is available from the FSANZ website (see useful Links of this newsletter).

New Zealand Ingredients

We have had enquiries from clients regarding certain lists that are circulating which claim to show a large number of ingredients that are available in New Zealand but not available in Australia. In fact, we have seen and examined some of these lists, and many of the ingredients named are already permitted in Australia; but are included in the list with inaccurate nomenclature. This then significantly reduces the number of ingredients that are not currently permitted in Australia.

Robert Forbes & Associates is keen to work with the relevant industry associations in presenting to the TGA a proposal that certain ingredients available overseas be made available locally. Ayurvedic herbs not available in Australia are a particular concern. If any companies have identified ingredients which they believe should be made available, please forward the names of these ingredients to us or to the CHC. Please ensure that botanical ingredients are listed by their botanical name, not by common name or a component name.

Conferences and Meetings 2002

Food Additives - Identifying Future Trends
December 4, Leatherhead, Surrey, UK
http://www.foodlineweb.co.uk/foodadditives/

Pharmaceutical Science Beyond the Genome: Harnessing the Potential
8 - 11 December, Carlton Crest Hotel, Melbourne
http://www.msit.com.au/apsa/