Adverse drug reactions bulletin

The December 2003 and February 2004 issues of the Australian Adverse Drug Reactions Bulletin are available.

Articles in the December 2003 issue <http://www.tga.gov.au/adr/aadrb/aadr0312.htm> include:

• Meningococcal C vaccine: early experience is reassuring
• Harmful interactions
• Post-partum NSAIDs may cause hypertension

Articles in the February 2004 issue <http://www.tga.gov.au/adr/aadrb/aadr0402.htm> include:

• Risk factors for myopathy and rhabdomyolysis with the statins
• High dose cyproterone and hepatotoxicity
• Serotonin syndrome

ADEC 231 and 232

Recommendations from the 231st (December 2003) <http://www.tga.gov.au/docs/html/adec/adec0231.htm> and 232nd (February 2004) <http://www.tga.gov.au/docs/html/adec/adec0232.htm> meetings of the Australian Drug Evaluation Committee are available.

Australian regulatory guidelines for prescription medicines

Comments on a draft of the Australian Regulatory Guidelines for Prescription Medicines are now being reviewed before the final document is published.

CMEC 41, 43 and 44

The public recommendation summaries for the 43rd (November 2003) <http://www.tga.gov.au/docs/html/cmec/cmecdr43.htm> and 44th (February 2004) <http://www.tga.gov.au/docs/html/cmec/cmecdr43.htm> meetings of the Complementary Medicines Evaluation Committee (CMEC) and the extracted ratified minutes of the 41st (August 2003) <http://www.tga.gov.au/docs/html/cmec/cmecdr41.htm> meeting are available.

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Colourings for use in medicines for ingestion

This draft document is intended to provide a list of colourings permitted for use in complementary, prescription, and OTC medicines for ingestion. Comments from OTC and complementary medicine stakeholders on the list should be submitted to the Office of Complementary Medicines by 8 April 2004.

Common technical document

The TGA currently accepts applications to register prescription medicines in both the old European Union (EU) format and the new Common Technical Document (CTD) format <http://www.tga.gov.au/docs/html/eugctd.htm>. The final date for submissions prepared in the old format will be 30 June 2004. After this date, the TGA will only accept applications in the CTD format.

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ELF news

The list of proprietary ingredients which have been used in listed medicines but which are not usable in ELF 3 until further information is provided <http://www.tga.gov.au/cm/elf3pring.htm> has been updated, as has the Electronic Listing Facility user guide <http://www.tga.gov.au/docs/html/elfuserg.htm>. A pre-clearance application form for animal-derived ingredients <http://www.tga.gov.au/cm/forms/animder.htm> has been produced to assist users of ELF.

GMP clearance for prescription medicines

Sponsors and manufacturers are reminded that there has been a change in requirements for obtaining GMP clearance for overseas manufacturing sites. GMP certifi cates or equivalent evidence of GMP should not be submitted to the DSEB along with Category 1, 2 or 3 applications or self-assessable notifications. Instead, such documentation should be submitted to the TGA's Manufacturers Assessment Section along with an application for GMP clearance. When available, the GMP clearance letter should be forwarded to DSEB.

More information: GMP clearance for prescription medicines <http://www.tga.gov.au/pmeds/pm_gmp.htm>

Listing news

Therapeutic Goods (Listing) Notices have been gazetted for sodium sulfate (No. 3 of 2003 <http://www.tga.gov.au/legis/tgnlist0302.htm>) and Terminalia ferdinandiana (Kakadu plum) (No. 4 of 2003 <http://www.tga.gov.au/legis/tgnlist0304.htm>).

The list of substances that may be used as active ingredients in listed medicines in Australia <http://www.tga.gov.au/cm/listsubs.htm> has been updated.

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Medicines containing Piper methysticum (kava kava)

The list of products on the Australian Register of Therapeutic Goods containing Piper methysticum (kava kava) has been updated and a new fact sheet covering issues around medicines containing kava has been produced.

OTC medicines news

Since the last TGA News there have been a number of updates to the Australian Regulatory Guidelines for OTC Medicines (ARGOM) <http://www.tga.gov.au/docs/html/argom.htm>. The New medicine registration application form (OTC medicines) <http://www.tga.gov.au/docs/html/regist.htm> has also been updated. A review of the regulation of head lice treatments in Australia <http://www.tga.gov.au/docs/html/headlice.htm> has been published.

Quantified by input

This document has been developed in order to provide guidance on the appropriate criteria for permitting quantifi cation by input as an alternative to performing an assay for the content of an active ingredient(s) in a complementary medicine during batch release testing.

More information: Quantified by Input <http://www.tga.gov.au/docs/html/argcmqbi.htm>

Standards for export only medicine

Therapeutic Goods Order No. 70A has been gazetted - an amendment to Therapeutic Goods Order No. 70 Standards for export only medicine.

European Union guidelines

Guidelines adopted by the TGA are sourced from the Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH). Once a particular guideline has been adopted in Australia, it shall be regarded as part of Volume 1 of the Australian Guidelines for the Registration of Drugs (AGRD).

Since the last issue of TGA News, two new EU guidelines have been adopted in Australia.

More information: European Union guidelines: Newly published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

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 November 2003, five additions have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.