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TGA News Issue 52 (March 2007) - Medicines

Adverse drug reactions

The December 2006 and February 2007 issues of the Australian Adverse Drug Reactions Bulletin are available <http://www.tga.gov.au/adr/aadrb.htm>.

Articles in the February 2007 issue <http://www.tga.gov.au/adr/aadrb/aadr0702.htm> include:

  • Traditional Indian (Ayurvedic) and Chinese medicines associated with heavy metal poisoning
  • Zolpidem and bizarre sleep related effects
  • Increased risk of fractures associated with enzyme-inducing antiepileptic medicines

Articles in the December 2006 issue <http://www.tga.gov.au/adr/aadrb/aadr0612.htm> include:

  • Drug induced pancreatitis
  • Leflunomide and interstitial lung disease
  • Tumour necrosis factor alpha inhibitors
  • Subscribe to the Bulletin online

Complementary medicines news

Complementary medicines in the health system

The TGA was nominated by the Government as being responsible for coordinating the implementation of the Australian Government response to the recommendations of the Expert Committee on Complementary Medicines in the Health System.

The TGA has established the Complementary Medicines Implementation Reference Group <http://www.tga.gov.au/cm/cmtor.htm> to provide advice on and oversee the implementation of the Government Response.

The Group is chaired by Dr Michael Bollen, who was also Chair of the Expert Committee, and includes representatives and experts in complementary medicine research, education, industry and consumer matters.

Reports on the progress of the implementation of the government response are available <http://www.tga.gov.au/cm/cmreport2.htm>

Renaming of ingredient

The Therapeutic Goods Administration (TGA) Herbal Ingredient Names Committee (HINC) considered the naming of Serenoa serrulata at its twenty-eighth meeting.

HINC determined that 'Serenoa serrulata Hook' is a taxonomic synonym of 'Serenoa repens (Bartram) Small' and that Serenoa repens is considered to be the correct name of the two conspecific species. The HINC accepted the Approved Herbal Name (AHN) "Serenoa repens", to replace the AHN "Serenoa serrulata". This decision is also supported by the Uppsala Monitoring Centre1.

The new naming will be phased in over two years. Sponsors must ensure that the correct AHN, Serenoa repens, is used on their product labels at the next print run, or by 11 December 2008, whichever should occur first.

Serenoa serrulata and Serenoa repens are commonly known as Saw palmetto.

1 WHO Collaborating Centre for International Drug Monitoring., 2005., Accepted Scientific Names of Therapeutic Plants and their synonyms., Sweden., The Uppsala Monitoring Centre.

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, four new EU Guidelines have been adopted in Australia and one replaced/superseded. <http://www.tga.gov.au/docs/html/euguideh.htm>

Improving access to CMIs and PIs

In April 2005, the TGA released a Discussion Paper on the most appropriate means for improving consumer and professional access to web based copies of up-to-date Consumer Medicine Information (CMI) and Product Information (PI) <http://www.tga.gov.au/consult/2005/accesspmi.htm>.

The TGA is now able to provide more detail about each of the options discussed and report on the outcome of the consultations.

A Second Discussion Paper is now available <http://www.tga.gov.au/meds/accesspmi2.htm>. The purpose of this Second Discussion Paper is to seek stakeholder views on some revised options, including the TGA's preferred option. As the feedback from this consultation will also flow through into the development of practices for the Australia New Zealand Therapeutic Products Authority (ANZTPA) and joint regulatory scheme, feedback is sought from both New Zealand and Australian stakeholders.

The closing date for submissions is 30 March 2007.

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

Prescribing medicines in pregnancy

Further amendments have been made to the Prescribing medicines in pregnancy, 4th edition, booklet <http://www.tga.gov.au/docs/html/medpreg.htm>.

Price information code of practice

Following consideration by the National Coordinating Committee on Therapeutic Goods (NCCTG) and the Advertising Implementation Steering Group (AISG), the Price Information Code of Practice <http://www.tga.gov.au/meds/vipicop.htm> came into effect on a voluntary basis in all States and Territories, other than Queensland, from 1 February 2007. The Price Information Code of Practice already legally applied in Queensland.

The Price Code will permit the publication of prices of medicines listed in Schedules 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The Code does not regulate the provision of price information for medicines that are permitted to be advertised, such as over-the-counter medicines in Schedule 2 of the SUSDP, medicines in Schedule 3 that are in Appendix H of the SUSDP, or medicines that are exempt from scheduling.

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