Adverse drug reactions

The April and June 2006 issues of the Australian Adverse Drug Reactions Bulletin are available.

Articles in the June 2006 issue <http://www.tga.gov.au/adr/aadrb/aadr0606.htm> include:

• Problems with colloids in fluid resuscitation
• Reactivation of hepatitis B virus following cytotoxic or immunosuppressant therapy
• Sibutramine - Four years experience

Articles in the April 2006 issue <http://www.tga.gov.au/adr/aadrb/aadr0604.htm> include:

• Hepatotoxicity with black cohosh
• Medical Alert devices
• Interactions with macrolides
• Changes to ADRAC membership

Australia-US free trade agreement

Therapeutic Goods Amendment Bill (No. 2) 2005 (the Bill) was proclaimed on 3 April 2006 and has been registered in the Federal Register of Legislative Instruments as Legislative Instrument F2006L00889.

The amendments made to the Therapeutic Goods Act 1989 by the Bill will mean patent certification requirements have changed.

The changes made by the Bill mean requirements for certificates in relation to patents [as outlined in S26B (1)] only apply to applications that are required to submit evidence or information to establish the safety or efficacy of the goods as part of the registration or listing process.

In addition, only those applications that have relied (in whole or in part) on evidence or information that another person submitted to the Secretary to establish the safety or efficacy of other therapeutic goods that have already been listed or registered will now be required to provide a certification.

In all other cases all that is required is a notification to the Secretary that the provisions of S26B (1) do not apply to the application to register or list the medicine on the Australian Register of Therapeutic Goods.

What does this mean for the listing process and the Electronic Listing Facility (ELF)?

A new part has been added to the online ELF application entitled "Subsection 26B (1) Notification", to enable sponsors to electronically notify the Secretary that the certification requirements of Subsection 26B (1) do not apply to an application.

For further advice on using ELF please call the ELF Helpdesk on 1800 773 312.

Complementary medicines

Regulation overview

In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'. Complementary medicines comprise traditional medicines, including traditional Chinese medicines, Ayurvedic medicines and Australian indigenous medicines.

See: The regulation of complementary medicines in Australia - an overview <http://www.tga.gov.au/cm/cmreg-aust.htm>

Draft regulation impact statement

A Consultation (Draft) Regulation Impact Statement has been prepared to address the changes that are proposed in the draft Medicines Rule, to the way in which herbal and homoeopathic medicines are currently regulated in Australia.

The draft RIS is available and stakeholders are invited to provide written comments on this document <http://www.tga.gov.au/cm/ris-herbal.htm>.

The draft Medicines Rule was published for consultation on 23 May 2006 and is available on the ANZTPA website for comment <http://www.anztpa.org>.

The consultation for both these documents closes on 15 August 2006.

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, 8 new EU guidelines have been adopted in Australia, 3 replaced/superseded, and 1 not adopted. See: EU guidelines - newly published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

Listing news

Therapeutic Goods (Listing) Notice 2006 (No. 3) (Trametes versicolor proteoglycan concentrate) <http://www.tga.gov.au/legis/tgnlist0603.htm>has been registered in the Federal Register of Legislative Instruments. A draft compositional guideline for this substance is available <http://www.tga.gov.au/docs/html/compguid/compdr.htm>.

The final compositional guideline for hydroxycitrate complex is available <http://www.tga.gov.au/docs/html/compguid/hydroxycitrate.htm>.

Medicines committees update

• ADEC: recommendations from meetings 245 & 246 (March & June 2006) <http://www.tga.gov.au/docs/html/adec/adecrecs.htm>
• CMEC: public recommendation summaries for meetings 56 & 57 (April & June 2006) and extracted ratified minutes for meetings 55 & 56 (February & April 2006) <http://www.tga.gov.au/docs/html/cmec/cmecminu.htm>
• MEC: meeting dates for the second half of 2006 <http://www.tga.gov.au/docs/html/mecinfo.htm>

Medicines forms & publications

The following forms & publications have been updated since the last issue of TGA News. Please ensure you are using the current versions.

• Application for selected non-disclosure of active herbal extract details <http://www.tga.gov.au/cm/forms/asndherbal.htm>
• ELF user guide <http://www.tga.gov.au/docs/html/elfuserg.htm>
• Substances that may be used as active ingredients in 'Listed' medicines in Australia <http://www.tga.gov.au/cm/listsubs.htm>

Medicines labelling

Advisory statements for medicines

The consultation document Consolidated Advisory Statement Requirements for Medicine Labels (CASRML) consolidates all Australian label advisory statement requirements for medicines in one place <http://www.tga.gov.au/label/casrml-dr.htm>.

The document is intended to form the basis for:

• Agreement that all relevant Australian medicine label advisory statements are captured; and
• Future consultations on transition to a new document to be introduced at the commencement of the Australia New Zealand Therapeutic Products Authority.

This document is not intended to replace the current edition of the Required Advisory Statements for Medicine Labels (RASML) <http://www.tga.gov.au/meds/rasml.htm>.

The CASRML consultation closes 21 July 2006.

ANZTPA

In April 2005, the consultation document Draft Labelling Requirements for Medicines under a Joint Australia New Zealand Therapeutic Products Agency was released for stakeholder comment.

Now available on the ANZTPA website <http://www.anztpa.org> are the Report on stakeholder consultation and consideration by the Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines of issues raised in stakeholder responses and a new document for consultation - General Requirements for the Labelling of Medicines (draft - May 2006) for application by the Australia New Zealand Therapeutic Products Authority.

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 the last issue of TGA News, 7 additions have been made to the list of drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>.

Topical non-prescription medicines

Full article: Change to requirements for assessing the safety of new excipients in topical non-prescription medicines <http://www.tga.gov.au/meds/topicalnpm.htm>