Adverse drug reactions bulletin

The June 2005 issue of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb/aadr0506.htm> is available.

Articles in the June issue include:

• Acne, isotretinoin and suicidality
• Genitourinary symptoms with reboxetine
• The multiple toxicities of amiodarone
• Antidepressants in children and adolescents
• Pimecrolimus, skin cancer and lymphoma

ADEC update

Recommendations from the Australian Drug Evaluation Committee's 239th (March/April 2005) <http://www.tga.gov.au/docs/html/adec/adec0239.htm> and 240th (June 2005) <http://www.tga.gov.au/docs/html/adec/adec0240.htm> meetings are available.

Ayurvedic medicines

Safety of Ayurvedic medicines in Australia - April 2005 <http://www.tga.gov.au/cm/ayurvedic.htm>

British Pharmacopoeia

From 1 July 2005, the British Pharmacopoeia defined under the Therapeutic Goods Act 1989 is the British Pharmacopoeia 2004. This was registered with the Federal Register of Legislative Instruments <http://www.tga.gov.au/legis/bp2004.htm> on 25 May 2005.

CMEC update

Public recommendation summaries for the 50th (February 2005) <http://www.tga.gov.au/docs/html/cmec/cmecdr50.htm> and 51st (June 2005) <http://www.tga.gov.au/docs/html/cmec/cmecdr51.htm> meetings of the Complementary Medicines Evaluation Committee are available.

Codex

Fact sheet - Codex <http://www.tga.gov.au/cm/fs_codex.htm>

Disruptions to the supply of medicines

From time to time, there are shortages of medicines due to a number of factors, for example:

• a company's just-in-time manufacturing and supply strategies
• manufacturing bottlenecks or other difficulties in manufacturing plants
• shortages in the supply of necessary imported ingredients
• unavailability of the finished product from overseas manufacturers
• delays in stock movement between manufacturers and wholesalers.

Sponsors are reminded that where shortages occur that could disadvantage patients, the TGA should be notified as early as possible in order to maximise the opportunity to facilitate supply and, if this is not possible, help identify and expedite the availability of alternative products.

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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Since the last issue of TGA News, 17 EU Guidelines have been adopted in Australia, 2 replaced/superseded, and 2 not adopted.

• European guidelines - newly published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

Hydroxycitrate complex

Update on Hydroxycitrate complex - May 2005 <http://www.tga.gov.au/cm/hydroxycitrate.htm>

Listing news

Since the last issue of TGA News, the following substances have been gazetted for use in listable therapeutic goods.

• Morinda citrifolia fruit powder <http://www.tga.gov.au/legis/tgnlist0504.htm>
• Asparagus racemosus dried, peeled root <http://www.tga.gov.au/legis/tgnlist0503.htm>
• Arthrospira maxima <http://www.tga.gov.au/legis/tgnlist0502.htm>
• Arthrospira platensis <http://www.tga.gov.au/legis/tgnlist0502.htm>
• Canarium indicum variant indicum seed oil <http://www.tga.gov.au/legis/tgnlist0501.htm>

Draft compositional guidelines <http://www.tga.gov.au/docs/html/compguid/compdr.htm> are available for all of the above substances and also for Hydroxycitrate complex.

Medicines documents updated

Over the last couple of months the following documents have been updated.

• Australian pharmacovigilance guideline <http://www.tga.gov.au/adr/pharmaco.htm>
• Australian regulatory guidelines for complementary medicines (ARGCM) <http://www.tga.gov.au/docs/html/argcm.htm>
• Quantified by input <http://www.tga.gov.au/docs/html/argcmqbi.htm>
• Required advisory statements for medicine labels (RASML) <http://www.tga.gov.au/meds/rasml.htm>

Medicines labelling

In April 2005, two medicines labelling consultation documents were made available for stakeholder comment:

• Draft Labelling Requirements for Medicines Under a Joint Australia New Zealand Therapeutic Products Agency
• Draft Best Practice Guideline on Prescription Medicine Labelling

The consultation period closed on 17 June 2005 but the documents are still available on the JTA Project website <http://www.anztpa.org/label/labeldraft.htm>.

Pharmacovigilance guideline

The Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch <http://www.tga.gov.au/adr/pharmaco.htm> has been amended to reflect changes that have occurred to EU pharmacovigilance reporting documentation. It was gazetted in the Commonwealth of Australia Gazette on 29 June 2005.