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TGA News Issue 51 (November 2006) - Medicines

Adverse drug reactions bulletin

Subscribe to the ADRAC bulletin online

Readers can now subscribe to the Australian Adverse Drug Reactions Bulletin online <http://www.tga.gov.au/adr/adrac-bulletin-subscribe.asp>. Subscribers to the ADRAC-BULLETIN email list will receive an email notifying them when the latest issue of the Bulletin is available on the TGA website (normally once every two months).

Latest issues of the bulletin

The October and August 2006 issues of the Australian Adverse Drug Reactions Bulletin are available <http://www.tga.gov.au/adr/aadrb.htm>.

Articles in the October issue include:

  • Beware the triple whammy!
  • Leflunomide and peripheral neuropathy
  • Ezetimibe and depression - A possible signal
  • Subscribe to the Bulletin on-line

Articles in the August issue include:

  • Osteonecrosis of the jaw with bisphosphonates
  • Dose reduction of LMWH (enoxaparin) in chronic kidney disease
  • Life threatening blood dyscrasias with oral terbinafine

ARGOM update

The table 'Sunscreening agents permitted as active ingredients in listed products' in Chapter 10 of the Australian Regulatory Guidelines for OTC Medicines has been updated <http://www.tga.gov.au/docs/html/argom.htm>.

Australia-Canada parallel review project

The TGA and the Biologics and Genetic Therapies Directorate of Health Canada are undertaking a project called the Parallel Review Project. The project will involve the two agencies reviewing one or more submissions in parallel with an aim to enhance cooperation between regulators in various jurisdictions around the world.

DSEB workflow practices

In 2005-2006 a review was done which examined the workflow practices of the TGA's Drug Safety and Evaluation Branch with a view to aligning them with best practice and international standards. The final report of this review is now available <http://www.tga.gov.au/pmeds/dsebworkflow.htm>.

European Union guidelines

Guidelines adopted by the TGA <http://www.tga.gov.au/docs/html/euguideh.htm> are sourced from the Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH).

Since the last issue of TGA News, eleven new EU Guidelines have been adopted in Australia, one replaced/superseded, and three not adopted.

Extemporaneous compounding

The TGA recently met with a range of stakeholders with an interest in the pharmacy sector specialising in extemporaneous compounding, also known as compounding chemists. The purpose of the meeting was to discuss options and proposals for updated controls on compounding to apply in Australia under the trans Tasman therapeutic products regulatory scheme, given the growing number of compounding chemists.

The discussions covered a number of proposed changes to current arrangements that would be risk-based and recognise roles for both professional and regulatory oversight.

The proposals will be discussed at the next meeting of the National Coordinating Committee on Therapeutic Goods (NCCTG) with a view to developing revised regulation for the sector. Public release by the NCCTG of details of the revised regulatory scheme is planned for later in the year.

The NCCTG is a subcommittee of the Australian Health Ministers' Advisory Council (AHMAC). The AHMAC has previously acknowledged that public health concerns existed concerning the growth in the practice of extemporaneous compounding and endorsed continued development by the NCCTG, in consultation with stakeholders, of an appropriate regulatory response for managing health and safety risks of extemporaneously compounded therapeutic goods.

A background review by Oceania Health Consulting on the growth in the practice of extemporaneous compounding was released by the TGA on behalf of the NCCTG in September 2005; see Review of the need for further regulation of extemporaneous compounding <http://www.tga.gov.au/meds/extempcomp.htm>. A meeting between the consultant and key stakeholders was also held in September 2005, and comments and suggestion from that meeting contributed to development of the regulatory model now under consideration by the NCCTG.

Listing news

The document Substances that may be used in Listed medicines in Australia <http://www.tga.gov.au/cm/listsubs.htm> is current as at 30 June 2006.

The substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia. The list includes the approved role of the substance (active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.

Medicines committees update

Now available:

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

Product discontinuations

Discontinuing a medicine is a decision that most pharmaceutical companies will take at some point. The TGA and Medicines Australia want to ensure that the impact of such a decision on patients is minimised. Ensuring best practice in the notification of product discontinuations - draft best practice guidelines have been developed and are available on this website.

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