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Follow the links below to find information on the approval and licensing of drugs and medicines.
Follow the links to the specific topic pages below to find information about the approval of new products, codes of practice and quality control.
The Australian Prescriber provides information on drugs recently marketed in Australia, appropriate use of diagnostic tests and interpretation of laboratory results.
The TGA - Therapeutic Goods Administration [Australian Government Department of Health and Ageing] is the Australian Government body that is responsible for carrying out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.
Updated January 2008
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Related HealthInsite Topics
Drug Standards and Best Practice
HealthInsite Topic Page
Links to information on drug manufacturing standards and best practice, including codes of conduct and international standards.
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Drug Evaluation
HealthInsite Topic Page
Links to information about the evaluation of drugs for use in Australia.
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Exporting Drugs
HealthInsite Topic Page
Links to information about exporting drugs from Australia.
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Regulation of Complementary Therapies and Medicines
HealthInsite Topic Page
Links to resources about the regulation and approval of the complementary and alternative therapies and medicines industry.
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Drug Monitoring
HealthInsite Topic Page
Links to information on the post market monitoring of the safety of prescription drugs.
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| Title: |
Draft compositional guidelines
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Complementary Medicine Compositional Guidelines are intended to provide clarity to the specific form or type of substances that the Therapeutic Goods Administration (TGA) approves for use in listed medicines.
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| Date: |
Aug 2008
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| Title: |
Fees & payments
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Summary of TGA fees and charges including explanatory notes
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| Date: |
Jul 2008
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| Title: |
Drugs designated as orphan drugs
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
A list of drugs that have been designated as 'orphan drugs' for the purposes of Regulation 16J of the Therapeutic Goods Regulations
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| Date: |
Jul 2008
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| Title: |
Guidance on product changes in ELF3
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may wish to change certain details previously advised to the TGA. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry for a particular product is necessary and the regulatory impact that making certain changes to currently Listed products may have.
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| Date: |
Jul 2008
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| Title: |
Regulation of complementary medicines
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
This page provides links to resources of relevance to complementary medicines.
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| Date: |
Jul 2008
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| Title: |
ARPANSA - Regulation: Medical Import Permit details
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| Publisher: |
Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)
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| Description: |
Under the Customs (Prohibited Imports) Regulations, a permit from ARPANSA is required for the import of radioactive material.
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| Date: |
Mar 2008
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| Title: |
Guidance on the GMP clearance of overseas medicine manufacturers
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
This guidance document is intended to provide information on what is regarded by the TGA as an acceptable form of evidence, and guidance for sponsors and manufacturers on the submission of that evidence to the TGA for assessment. It is not intended to provide a definitive list of forms of evidence that are considered acceptable or unacceptable.
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| Date: |
Mar 2008
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| Title: |
Substances that may be used in listed medicines in Australia
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The following 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 (ie. active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.
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| Date: |
Dec 2007
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| Title: |
Prescription medicine registration form and guide
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Application for Registration / to Vary the Conditions of Registration for Prescription Medicines in Australia form.
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| Date: |
Oct 2007
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| Title: |
The regulation of complementary medicines in Australia - An overview
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'.
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| Date: |
Apr 2007
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| Title: |
Improving access to palliative care medicines
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| Publisher: |
Consumers' Health Forum of Australia (CHF)
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| Description: |
Consumers have benefited from the work of the Palliative Medicines Working Group to get palliative care medicines approved for the Pharmaceutical Benefits Scheme.
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| Date: |
Apr 2007
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| Title: |
Media release - Scheduling of orlistat
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The National Drugs and Poisons Schedule Committee (NDPSC) reconsidered the scheduling and advertising status of orlistat (contained in the medicine Xenical) at its February 2007 meeting.
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| Date: |
Feb 2007
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| Title: |
Implementation of the Government Response to the recommendations of the Expert Committee on Complementary Medicines in the Health System
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
An audit of progress with implementing the Government Response was conducted to gain a clear indication of progress to date, to identify key stakeholders, and to inform the development of an Implementation Plan for further action. Areas with responsibility for implementing the Government Response, including the TGA, other areas of the Department of Health and Ageing (DoHA), the Department of Education, Science and Training, and the Department of Industry, Tourism and Resources, were consulted.
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| Date: |
Dec 2006
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| Title: |
Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (version 4.0)
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Pharmaceutical Benefits Advisory Committee (PBAC) endorsed this edition of its Guidelines in November 2006. It follows an extensive consultation process and provides guidance for all stakeholders involved in or affected by submissions to the PBAC or listings on the Pharmaceutical Benefits Scheme or the National Immunisation Program.
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| Date: |
Dec 2006
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| Title: |
Scheduling of medical devices
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Sponsors are reminded that medical device products containing a substance scheduled in accordance with the recommendations of the National Drugs and Poisons Schedule Committee (NDPSC) must be appropriately labelled as required for the assigned schedule.
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| Date: |
Oct 2006
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| Title: |
Listing of Herceptin on the PBS
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Government has accepted a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) to list the drug trastuzumab (Herceptin?) on the Pharmaceutical Benefits Scheme (PBS).
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| Date: |
Oct 2006
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