ADEC 228 & 229

Recommendations from the 228th (June 2003) and 229th (August 2003) meetings of the Australian Drug Evaluation Committee are available

• ADEC 229th meeting recommendations <http://www.tga.gov.au/docs/html/adec/adec0229.htm>
• ADEC 228th meeting recommendations <http://www.tga.gov.au/docs/html/adec/adec0228.htm>

Prescription medicine fees & charges

The Commonwealth Cost Recovery Guidelines for Regulatory Agencies require agencies to prepare a Cost Recovery Impact Statement where it proposes to introduce, or make significant amendments, to cost recovery arrangements.

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 July 2003, one new EU Guideline has been adopted in Australia.

• European Guidelines - Newly Published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

Literature based submissions

Literature-Based Submissions - points to consider <http://www.tga.gov.au/docs/html/litbsubs.htm> has been recently updated. This document provides guidance to sponsors in compiling a literature-based submission. Adherence to this document is not a prerequisite for a submission to be accepted or approved. However, sponsors are encouraged to follow these recommendations.

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

Adverse drug reactions bulletin

The August and October 2003 issues of the Australian Adverse Drug Reactions Bulletin are available.

Articles in the August 2003 <http://www.tga.gov.au/adr/aadrb/aadr0308.htm> issue include:

• Maternal SSRI use and neonatal effects
• ACE inhibitor, diuretic and NSAID: a dangerous combination
• Serious gastrointestinal effects with celecoxib and rofecoxib
• Travacalm - your reports make a difference!

Articles in the October 2003 <http://www.tga.gov.au/adr/aadrb/aadr0310.htm> issue include:

• Rofecoxib, celecoxib and cardiovascular risk
• Convulsions and blood dyscrasias with mirtazapine
• Anti-epileptic drugs, pregnancy and fetal malformations
• Hormone replacement therapy

CMEC 41 & 42

Public recommendation summaries from the 41st (August 2003) and 42nd (September 2003) meetings of the Complementary Medicines Evaluation Committee are available.

• CMEC Meeting 42, 26 September 2003 Public Recommendation Summary <http://www.tga.gov.au/docs/html/cmec/cmecdr42.htm>
• CMEC Meeting 41, 1 August 2003 Public Recommendation Summary <http://www.tga.gov.au/docs/html/cmec/cmecdr41.htm>

Compositional guidelines

The compositional guideline for bovine colostrum powder <http://www.tga.gov.au/docs/html/compguid/bovinecp.htm> has been finalised.

Compositional guidelines <http://www.tga.gov.au/docs/html/compguid/compguid.htm> are intended to provide clarity to the specific form or type of substances that the TGA approves for use in listed medicines, as either an active substance or an excipient, where there is no standard in the British Pharmacopoeia or other acceptable monographs.

Greater celandine

At its meeting in August 2003, the CMEC considered a more complete safety review of the herb Greater celandine (Chelidonium majus) undertaken by the TGA.

The CMEC examined all of the available evidence linking ingestion of C. majus with moderate to severe, reversible acute hepatitis in a relatively small number of individuals worldwide.

The CMEC has recommended that the TGA maintain Chelidonium majus as a listable substance, but that oral products be required to include a label warning statement.

• Proposed labelling advisory statement for the herb greater celandine (Chelidonium majus) <http://www.tga.gov.au/docs/html/celandine.htm>

Listing notices

Therapeutic Goods (Listing) Notice 2003 (No. 2) <http://www.tga.gov.au/legis/tgnlist0302.htm> was gazetted on 13 August 2003. The notice relates to cold-pressed neem (Azadirachta indica) seed oil and calcium sodium caseinate.

Proprietary ingredients

The list of Proprietary ingredients which have been used in listed medicines but which are not usable in ELF3 until further information is provided <http://www.tga.gov.au/cm/elf3pring.htm> has been updated.

Ingredients in this list are not usable in ELF 3 (Electronic Lodgement Facility) until information regarding proprietary ingredient purpose, restricted ingredients and quantities of restricted ingredients have been supplied to the TGA.

Australian regulatory guidelines for OTC medicines

The Australian Regulatory Guidelines for OTC Medicines (ARGOM) <http://www.tga.gov.au/docs/html/argom.htm> was updated in October with the addition of Chapter 10 - Sunscreens and the updating of the sodium content guideline in Chapter 9.