Regulation of medical software and mobile medical ‘apps’ – TGA – 13 September 2013

Posted on September 17, 2013. Filed under: Health Informatics, Health Technology Assessment | Tags: , |

Regulation of medical software and mobile medical ‘apps’ – TGA – 13 September 2013

“Software is becoming increasingly important in medical devices; however, its rapid evolution, particularly in relation to mobile technology, presents new and complex challenges for the TGA and regulatory agencies internationally.

The following is intended to provide guidance on the regulatory arrangements pertaining to medical software and mobile medical apps by addressing some questions frequently put to the Therapeutic Goods Administration (TGA).

Are medical software products considered to be medical devices?

A software product is considered a medical device if it fits the definition in section 41BD of the Therapeutic Goods Act 1989.”

… continues on the site

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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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TGA reforms: a blueprint for TGA’s future – 8 December 2011

Posted on December 8, 2011. Filed under: Complementary & Altern Care, Health Technology Assessment, Pharmacy | Tags: |

TGA reforms: a blueprint for TGA’s future – 8 December 2011

“The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undertaken over the past 18 months.

These reviews include:

•the review to improve the transparency of the Therapeutic Goods Administration
•public consultations on the regulatory framework for advertising therapeutic goods
•the Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines
•an informal working group examining the regulation of complementary medicines and reasons for low compliance rates
•public consultations on the medical devices regulatory framework
•the Working Group on Promotion of Therapeutic Products
•the Health Technology Assessment Review.

The Government’s response takes into account submissions made by stakeholders, and draws this work together into a comprehensive package of reforms that will be progressed in stages.

The reforms will enhance the regulatory framework, ensuring that it remains adaptable to new scientific developments and emerging community expectations.

They will also improve the Australian community’s understanding of the TGA’s regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.”

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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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