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Follow the links to information on how drugs are evaluated for entry into the market.
Reviewed January 2008
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| Title: |
Australian Drug Evaluation Committee resolutions
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Recommendations for approval of new drugs or changes to registration of existing drugs from the Meetings of the Australian Drug Evaluation Committee.
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| Date: |
Jul 2008
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| Title: |
Australian Drug Evaluation Committee (ADEC)
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Australian Drug Evaluation Committee (ADEC) was formed to provide independent, scientific advice on new drugs, within the policy framework of the time. This site discusses its role, the guidelines it follows, and its subcommittees.
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| Date: |
Jun 2008
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| Title: |
Complementary Medicines Evaluation Committee (CMEC)
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Complementary Medicines Evaluation Committee provides scientific and policy advice relating to controls on the supply and use of complementary medicines. The advice is provided with particular reference to safety, quality of products and where appropriate, efficacy relating to the claims made.
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| Date: |
Mar 2008
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| Title: |
Medicines Evaluation Committee (MEC)
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Medicines Evaluation Committee (MEC) provides independent scientific and policy advice on OTC medicines to the Minister and the Australian Government Department of Health and Ageing through the Therapeutics Goods Administration.
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| Date: |
Mar 2008
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| Title: |
How prescription drugs are developed
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| Publisher: |
Australian Prescriber
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| Description: |
Modern drug development is a risky business both for pharmaceutical companies and patients. Many thousands of promising compounds need to be tested.
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| Date: |
Dec 2006
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| Title: |
ADEC Pharmaceutical Subcommittee meeting recommendations
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Pharmaceutical Subcommittee makes recommendations to ADEC on the pharmaceutical chemistry, quality control, bioavailability and pharmacokinetics of prescription medicines proposed for registration in Australia.
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| Date: |
Nov 2006
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| Title: |
Analytical procedure validation for complementary medicines
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
These guidance documents describe the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines.
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| Date: |
Mar 2006
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| Title: |
Government information on adverse medical events
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| Publisher: |
Consumers' Health Forum of Australia (CHF)
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| Description: |
Review of the Therapeutic Goods Administration (TGA) website as a source of information about medicines for consumers.
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| Date: |
Jan 2006
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| Title: |
Transparency - in the eye of the beholder?
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| Publisher: |
Australian Prescriber
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| Description: |
The Editorial Executive Committee of the Australian Prescirber express their concern about the increasing difficulty of obtaining good information on new drugs.
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| Date: |
Aug 2005
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| Title: |
Two-way transparency
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| Publisher: |
Australian Prescriber
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| Description: |
For several years there have been complaints about the transparency of the Australian drug regulatory system. The Pharmaceutical Benefits Advisory Committee has been working with the pharmaceutical industry to address some of these criticisms.
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| Date: |
Aug 2005
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| Title: |
Exporting medicines from Australia - Operational guidelines
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The aim of these guidelines is to enhance transparency in the operations of the Export Medicines Unit of the TGA and ensure consistency in the administrative processes which support the Therapeutic Goods legislation.
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| Date: |
Sep 2004
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| Title: |
Why are children still therapeutic orphans? (Editorial)
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| Publisher: |
Australian Prescriber
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| Description: |
Many marketed drugs that are commonly used, or could potentially be used in children, have not been studied in the relevant age groups and so are not approved by regulatory authorities for use in children.
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| Date: |
Dec 2003
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| Title: |
Traditional Chinese medicines (Comment for consumers)
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| Publisher: |
Australian Prescriber
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| Description: |
Patients need to be aware that the quality of traditional Chinese medicines can vary. If you decide to take traditional Chinese medicine you should make sure that the person who prescribes it has some qualifications in how to prepare the medicines.
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| Date: |
Dec 2003
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| Title: |
History of the Australian Drug Evaluation Committee
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Discussions between the Commonwealth Department of Health and senior Australian clinicians led to the establishment of the Australian Drug Evaluation Committee as an independent committee to advise on the safety of new drugs being imported into Australia and to formulate measures for the evaluation of possible adverse affects of drugs that were being used in Australia.
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| Date: |
Oct 2003
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