Guidelines for Sterility Testing of Therapeutic Goods
The TGA has issued new guidelines for the sterility testing of therapeutic goods and devices, to be used by manufacturers and TGA laboratories. http://www.health.gov.au/tga/docs/html/sterilit.htm
Advertising Sunscreens
A gazettal notice dated 13th September, approved the use of the claims "may assist in preventing some skin cancers" and "reduce the risk of some skin cancers" for broad spectrum 30+ sunscreens. On the provision that the advertisement highlights:
§ avoid prolonged exposure to the sun and
§ the importance of wearing protective clothing, hat and eyewear.
http://www.health.gov.au/tga/docs/html/reg7csun.htm
Q&A on New Code of Manufacture
The TGA has set out a series of Questions and Answers on the New Code of Manufacturing Practice. This document includes questions and answers on manufacture of sterile products, herbal products and biological medicinal products; computerized systems; and qualification and validation.
http://www.health.gov.au/tga/docs/html/gmpcodqa.htm
Child Resistant Packaging – New Draft Therapeutic Goods Order
The current TGO 20 on Child Resistant Packaging and TGO 33 - the Amendments to TGO 20, are under review. A draft new TGO is available for stakeholder consultation and is available to download at: http://www.health.gov.au/tga/docs/html/tgo/tgo65dr.htm
Comments on the draft to be forwarded to the TGC Secretary by 13 November 2002.
World’s First Electronic On-Line Application System
The new regulatory system for Medical Devices was introduced in Australia on 4 Oct 2002.
http://www.health.gov.au/tga/docs/html/meddevreg.htm
With the new system comes the world's first web based electronic application lodgement system. The new DEAL (Device Electronic Application Lodgement) system for Medical Devices is now operational and handles on-line electronic applications for all classes of medical devices onto the ARTG.
Medical devices that were exempt on the ARTG will remain exempt for 2 years until 4 October 2004. After that time, if they no longer satisfy the definition of exempt goods (such as non-sterile surgical instruments), they will have to meet the provisions of the new system. Medical devices, manufactured in Australia which did not require a GMP licence under the previous regulations will be able to continue to apply for 'listing' on the ARTG until 4 October 2004. Any products listed, under these circumstances, between 4 October 2002 and 4 October 2004 will have until 4 October 2007 to meet the requirements of the new system. DEAL will be able to be used to lodge these applications for the listable products with this two-year exemption. http://www.health.gov.au/tga/docs/html/meddevreg.htm#gen
New Fees Medical Device Application and Assessment
A summary of the fees and charges for Medical Devices under the new regulatory system is now available. New fees and charges apply only to devices regulated under the new system. For all listable and registrable devices currently on the ARTG and not transferred to the new system the fees set for the 2002/03 financial year will continue to apply. http://www.health.gov.au/tga/docs/html/devfees.htm
Regulation of the Re-manufacture of Single Use Devices for Reuse
The TGA is seeking comments regarding implementation of a national regulatory framework for reprocessing of single use devices for reuse. Comments are required by October 31st
http://www.health.gov.au/tga/docs/html/devreuse.htm
TGA Information Seminar Notes
The TGA Information Seminar held in Canberra on 2 October on the import, export and distribution of restricted substances, has the presentation notes available at:
http://www.health.gov.au/tga/docs/html/export/sem0210.htm
Recalls
On 4th October the following product was issued a Class I Recall due to the possibility that a batch may be contaminated with capsules containing bee pollen:
Nature's Sunshine Golden Seal 500mg Capsules (Batch 00134802Exp01/07)
[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
On 10 September the TGA/Industry Consultation Group AGCM met and has advised that a draft industry consultation document for Australian Guidelines for Complementary Medicines will be available for comment around mid-October.
The Food Standards Australia New Zealand (FSANZ), has invited comment before November 20, on proposed changes to the Food Standards Code, including:
- a review of kava, which will examine toxicity and safety of extracts used in food products. The current standard permits raw kava but prohibits it from being mixed with other foods.
- a recommendation for the use of gamma-cyclodextrin, used as a flavour, colour or sweetener carrier as a novel food ingredient.
- a recommendation that d-tagatose, a naturally occurring monosaccharide, be permitted as a novel food - for use as an alternative sweetener claiming lower energy value.
- a recommendation the enzyme transglucosidase sourced from aspergillus niger, be permitted as a processing aid.
http://www.foodstandards.gov.au/standardsdevelopment/documentsforpublicco868.cfm
The American Botanical Council (ABC) has produced a science-based review of black cohosh, a herbal supplement used to treat menopausal conditions. This extensive review is well referenced and available at: http://www.herbalgram.org/files/pdfs/black_cohosh_20020729.pdf
United States Pharmacopeia New Edition
The 2003 Edition of the United States Pharmacopeia - USP 26-NF 21, will be published in November, and becomes official on Jan. 1, 2003. It contains 4000 drug monographs including herbal drugs and excipient substances.
The ACCC has instituted court proceedings against two companies selling health related products on the web. This follows a worldwide Internet Sweep (carried out by the International Marketing Supervision Network) for false claims about health products earlier this year, which resulted in 18 companies facing legal action. Proceedings against Danoz Direct alleged misleading and deceptive conduct in the marketing of Abtronic on its website, as well as TV commercials and catalogues. The case will be heard on Oct 28.
The ACCC has also asked the Federal Court for injunctions, corrective statements and refunds against Transformation 2012 about website claims to treat or assist in curing cancer, AIDS, diabetes, herpes, hepatitis, flu, asthma, migraine, MS.
Out of Court settlements were reached with a further 10 Australian companies, with the assistance of state fair trading authorities, TGA, state health complaints offices and the ACCC.
Court proceedings against companies in the US, New Zealand, Portugal, Austria, Switzerland, Belgium, France, Japan and UK are still proceeding as a result of the worldwide sweep where 1,400 websites were identified as ‘suspicious’. http://www.theage.com.au/articles/2002/09/25/1032734205684.html
At a three-day meeting held in Sydney, the US Federal Trade Commission (FTC) and members of the International Marketing Supervision Network (IMSN) announced two initiatives to combat cross-border fraud. This included the unveiling of the newly designed Web site, www.econsumer.gov , where consumers can file cross-border e-commerce complaints that can be accessed by IMSN partners. This initiative demonstrates to offenders they cannot escape law enforcement scrutiny by setting up shop in one country and targeting consumers in another.
http://www.npicenter.com/index.asp?action=NBViewDoc&DocumentID=3305
First Monograph for Supplement Released
The US Institute of Medicine (IOM) has released a first draft prototype monograph. The monograph is intended to be a concise, not comprehensive, literature review on safety, not benefits. Chaparral is the first of six ingredients chosen for review, others including saw palmetto, melatonin, chromium picolinate, glucosamine, and shark cartilage. The draft is available at: http://www.iom.edu/iom/iomhome.nsf/WFiles/ChaparralDraft/$file/ChaparralDraft.pdf
Soy Sales Expected to reach $3.5billion in US in 2002
National Newspaper – USA Today reports that sales in the US of soy products will reach $3.5 billion this year, in part due to the recent claims that one HRT product had increased health risks associated with it.
http://www.npicenter.com/index.asp?action=NBViewDoc&DocumentID=3300
US Issued Mandatory Warnings on Ephedra Labels
The US Department of Health and Human Services (HHS) requested the strongest possible warning labels and GMP regulations for Ephedra supplements.
http://www.npicenter.com/index.asp?action=NBViewDoc&DocumentID=3380