Drug Evaluation

Follow the links to information on how drugs are evaluated for entry into the market.

Reviewed January 2008

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25 Resources Found
Results 1 to 20 displayed.
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Title:   Australian Drug Evaluation Committee resolutions
Publisher:   Australian Government Department of Health and Ageing
Description:   Recommendations for approval of new drugs or changes to registration of existing drugs from the Meetings of the Australian Drug Evaluation Committee.
Date:   Jul 2008
Title:   Australian Drug Evaluation Committee (ADEC)
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Jun 2008
Title:   Complementary Medicines Evaluation Committee (CMEC)
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Mar 2008
Title:   Medicines Evaluation Committee (MEC)
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Mar 2008
Title:   How long does it take to evaluate a prescription medicine?
Publisher:   Australian Government Department of Health and Ageing
Description:   The time taken by the TGA to evaluate an application for registration of a prescription medicine depends on a number of factors.
Date:   Feb 2008
Title:   Media release. $15.4 million for new palliative care initiatives
Publisher:   Australian Government Department of Health and Ageing
Description:   The Australian Government today announced more than $15 million in funding for two new palliative care initiatives.
Date:   Aug 2007
Title:   How prescription drugs are developed
Publisher:   Australian Prescriber
Description:   Modern drug development is a risky business both for pharmaceutical companies and patients. Many thousands of promising compounds need to be tested.
Date:   Dec 2006
Title:   ADEC Pharmaceutical Subcommittee meeting recommendations
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Nov 2006
Title:   Analytical procedure validation for complementary medicines
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Mar 2006
Title:   Consumer input in the Australian Drug Evaluation Committee (ADEC): Summary evaluation of 2002-04 pilot project
Publisher:   Consumers' Health Forum of Australia (CHF)
Description:   Summary of the evaluation of the pilot project to provide consumer submissions about prescription medicines to the Therapeutic Goods Administration.
Date:   Mar 2006
Title:   Submission to the discussion paper : workflow practices within the Drug Safety & Evaluation Branch of the Therapeutic Goods Administration
Publisher:   Consumers' Health Forum of Australia (CHF)
Description:   This submission outlines key consumer issues relating to the review of the Therapeutic Goods Administration (TGA) branch that evaluates and monitors prescription medicine applications in Australia.
Date:   Feb 2006
Title:   Regulating medicines - where do generics fit?
Publisher:   Consumers' Health Forum of Australia (CHF)
Description:   Generic medicines are monitored and regulated by the Therapeutic Goods Administration.
Date:   Jan 2006
Title:   Government information on adverse medical events
Publisher:   Consumers' Health Forum of Australia (CHF)
Description:   Review of the Therapeutic Goods Administration (TGA) website as a source of information about medicines for consumers.
Date:   Jan 2006
Title:   Transparency - in the eye of the beholder?
Publisher:   Australian Prescriber
Description:   The Editorial Executive Committee of the Australian Prescirber express their concern about the increasing difficulty of obtaining good information on new drugs.
Date:   Aug 2005
Title:   AHMAC Paediatric Pharmaceuticals Working Group interim report on assessment and registration of medicines for paediatric use
Publisher:   Consumers' Health Forum of Australia (CHF)
Description:   This submission offers a consumer perspective on some of the Paediatric Pharmaceutical Working Group's recommendations for increasing assessment and registration of medicines for use by children and it outlines ways that consumers may support implementation of various proposed strategies relating to child health.
Date:   Aug 2005
Title:   Two-way transparency
Publisher:   Australian Prescriber
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.
Date:   Aug 2005
Title:   Exporting medicines from Australia - Operational guidelines
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Sep 2004
Title:   Why are children still therapeutic orphans? (Editorial)
Publisher:   Australian Prescriber
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.
Date:   Dec 2003
Title:   Traditional Chinese medicines (Comment for consumers)
Publisher:   Australian Prescriber
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.
Date:   Dec 2003
Title:   History of the Australian Drug Evaluation Committee
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Oct 2003
Results 1 to 20 displayed.
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