Australian statistics on medicines 2011 – Therapeutic Goods Administration – 17 January 2013

Posted on January 21, 2013. Filed under: Patient Safety, Pharmacy | Tags: , , |

Australian statistics on medicines 2011 – Therapeutic Goods Administration – 17 January 2013

“Australian Statistics on Medicines is produced by the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC) and is aimed at providing comprehensive and valid statistics on the Australian use of medicines in the public domain to allow access by all interested parties.

The report from the OPR includes a brief overview on the following aspects of post-market monitoring of medicines in Australia:

•Adverse event reporting statistics for 2011
•Processing and use of adverse event reports
•Reporting adverse events
•Expert advisory committee
•Medicines Safety Update
•Product vigilance”

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Review to improve the transparency of the Therapeutic Goods Administration: Final Report – June 2011

Posted on July 22, 2011. Filed under: Health Technology Assessment, Pharmacy | Tags: , |

Review to improve the transparency of the Therapeutic Goods Administration: Final Report – June 2011

Extract from the Executive Summary:

“The Therapeutic Goods Act 1989 states as its principal object ‘to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods’ that are used in Australia or exported from Australia. This system is achieved through the operation of the Therapeutic Goods Administration (TGA), a Division of the Department of Health and Ageing.

A perception has arisen in the community that the TGA does not provide the public with sufficient information about its activities and about the therapeutic goods that it regulates. This perception led the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, to establish a panel of consumer, health practitioners and therapeutic goods industry representatives to review and report on the transparency of the TGA.”

ISBN: 978-1-74241-523-9
Online ISBN: 978-1-74241-524-6
Publications Approval Number-D0482

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TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age – 3 December 2009

Posted on December 3, 2009. Filed under: Influenza A(H1N1) / Swine Flu | Tags: , , , |

TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age
3 December 2009

“Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has today approved the use of Panvax® H1N1 influenza vaccine to include children aged from 6 months of age.

In addition, the TGA has also approved Panvax H1N1 Junior® influenza vaccine specifically for use in children aged from 6 months up to 3 years of age.

The TGA approved the use of Panvax® H1N1 influenza vaccine in children, and Panvax H1N1 Junior®, following analysis of paediatric clinical trial data.

The TGA approved Panvax® H1N1 influenza vaccine on 18 September 2009 for use in adults and children over 10 years of age.

Panvax® H1N1 influenza vaccine and Panvax H1N1 Junior® are manufactured by the Australian company, CSL Limited, using the same processes as those used to manufacture seasonal influenza vaccines.

Information on the vaccination dosage and planned roll-out of the vaccine programme can be found at http://www.healthemergency.gov.au.

Healthcare practitioners and consumers are encouraged to report any side effects by telephoning 18 02 007 or by using the online reporting form available from the TGA website at http://www.tga.gov.au/problem/panvaxh1n1.htm.

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Consumer Medicines Information on the website of the Therapeutic Goods Administration

Posted on November 23, 2009. Filed under: Pharmacy | Tags: , , |

Search interface to the CMIs on the TGA’s website

About the site from TGA

“The Consumer Medicines Information (CMI) is a leaflet that contains information on the safe and effective use of a medicine.

The information has been written by the pharmaceutical company responsible for the medicine. TGA regulations require that CMI must be made available to consumers either in the pack or in another manner that will enable the information to be given to the person to whom the medicines are administered or otherwise dispensed.”

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