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TGA News Issue 49 (March 2006) - Medicines

Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.

Adverse drug reactions bulletin

The December 2005 and February 2006 issues of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> are available on the TGA Internet site.

Articles in the December 2005 issue <http://www.tga.gov.au/adr/aadrb/aadr0512.htm> include:

  • Medicines and QT prolongation
  • Skin reactions with glucosamine
  • Warfarin-induced skin necrosis

Articles in the February 2006 issue <http://www.tga.gov.au/adr/aadrb/aadr0602.htm> include:

  • Deaths with galantamine in mild cognitive impairment studies
  • Fluoroquinolone antibiotics
    • ...Interactions with warfarin
    • ...Remember tendon disorders
  • Ergot derivatives and fibrotic reactions

Black cohosh

The TGA recently reviewed the safety of Black cohosh (Cimicifuga racemosa) following reports of possible liver problems internationally and in Australia. Following this review there are now new labelling requirements for medicines containing Black cohosh.

Healthcare practitioners and consumers should look out for signs of liver toxicity associated with the use of Black cohosh medicines.

For more detailed information, see: New labelling and consumer information for medicines containing Black cohosh (Cimicifuga racemosa) <http://www.tga.gov.au/cm/0705blkcohosh.htm>.

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British pharmacopoeia 2005

In early 2006, stakeholder comment was sought on the adoption of the BP 2005 in Australia as the edition of that standard defined under the Therapeutic Goods Act 1989 and, in particular, on any specific difficulties for sponsors that may be associated with this action. The consultation closed on 24 February 2006.

Can a 'label' be an advertisement?

The TGA receives a number of enquiries from sponsors seeking advice as to whether a product label can be considered to be an 'advertisement', as defined by the Therapeutic Goods Act 1989.

The TGA confirms that a product label, when attached to a publicly available product, is an 'advertisement' if it includes statements (for example, indications for use), pictorial representations or other designs that are intended, whether directly or indirectly, to promote the use or supply of the goods.

This provides the legal basis for requiring label claims (and other representations) for non-prescription therapeutic products to comply with the Therapeutic Goods Advertising Code <http://www.tga.gov.au/advert/index.htm>.

Deadline for updating 'grandfather' products further extended

The deadline for 'fee free' updates to details of registered OTC and complementary medicines in the Australian Register of Therapeutic Goods (ARTG) has been further extended from 31 March 2006 to 31 March 2007.

Sponsors are encouraged to use the OPAL system to verify and, if necessary, update their ARTG records at the earliest opportunity. The intention is to ensure that all ARTG data are current, accurate and complete before the commencement of the joint agency.

The joint-agency-equivalent of the OPAL system will not accept applications for joint agency licences for Australian products that have not been updated via OPAL. After the 'fee free' period ends on 31 March 2007, sponsors must pay a lodgement fee (currently $790) for each product to be updated.

A step-by-step guide to the update of registered OTC and complementary medicines using OPAL <http://www.tga.gov.au/npmeds/otc_infosheet.htm> is available on the TGA Internet site.

For more detailed information, call the OPAL Help Desk on 1800 616 011.

Expert committee on complementary medicines

A progress report as at February 2006 on the Implementation of the Government Response to the recommendations of the Expert Committee on Complementary Medicines in the Health System <http://www.tga.gov.au/cm/cmreport2.htm> is available on the TGA Internet site.

European Union guidelines

Guidelines adopted by the TGA are sourced from the Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH).

Since the last issue of TGA News, eight EU Guidelines have been adopted in Australia and five have been replaced/superseded.

See: EU guidelines - newly published <http://www.tga.gov.au/doc/html/euguideh.htm#eugwnp>

Listing news

Since the last issue of TGA News, conifer green needle complex <http://www.tga.gov.au/legis/tgnlist0602.htm> and whole dried Undaria pinnatifida <http://www.tga.gov.au/legis/tgnlist0601.htm> have been gazetted for use in listable therapeutic products. Draft compositional guidelines <http://www.tga.gov.au/docs/html/compguid/compdr.htm> for these substances are available on the TGA Internet site.

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Medicines committees update

ADEC

CMEC

Orphan drugs

Orphan drug products are drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases. The Australian Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees.

Since last issue of TGA News, four updates have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.

Pseudoephedrine rescheduling

From 1 January 2006, all pseudoephedrine-containing medicines are removed from Schedule 2 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). These products will all initially be included in Schedule 3.

From 1 April 2006, all liquid preparations containing more than 800 mg of pseudoephedrine and all other preparations containing more than 720 mg of pseudoephedrine will be rescheduled to Schedule 4 of the SUSDP.

All medicines included in Schedules 3 and 4 of the SUSDP must have product information (PI) and consumer medicine information (CMI) documents.

For more information, including PI & CMI templates that can be used by sponsors, see: Pseudoephedrine rescheduling - information for sponsors <http://www.tga.gov.au/npmeds/pseudoephedrine.htm>.

S2 & S3 medicines

The Australian Health Ministers' Conference (AHMC) has considered the report prepared by the National Coordinating Committee on Therapeutic Goods (NCCTG) on the results of research into A Cost-Benefit Analysis of Pharmacist Only (S3) and Pharmacy Medicines (S2) and Risk-Based Evaluation of the Standards, commissioned by the Pharmacy Guild of Australia to implement Recommendation 5 of the Review of Drugs, Poisons and Controlled Substances Legislation <http://www.tga.gov.au/docs/html/rdpdfr.htm> (the 'Galbally Review').

AHMC has agreed to support the NCCTG recommendation that the Schedule 2 and Schedule 3 arrangements continue for five years and the compliance of pharmacists with relevant standards of practice be re-evaluated at the end of that period.

Full report and relevant links: Report to Health Ministers on a cost-benefit analysis of pharmacist only (S3) and pharmacy medicines (S2) and risk-based evaluation of the standards <http://www.tga.gov.au/meds/s2s3report.htm>

Topical non-prescription medicines

After 31 December 2005, sponsors who wish to include new excipients in topical non-prescription medicines will need to submit the required toxicological data prior to or concurrently with the listing/registration application. The application will not be approved before the excipient is cleared.

**Correction 5 April 2006: The change that was to have been introduced on 31 December 2005 was deferred pending further consultation with stakeholders.**

For more information see: Regulation of new excipients in topical non-prescription medicines <http://www.tga.gov.au/npmeds/topical.htm>

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