Drug Evaluation

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

Reviewed March 2009

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22 Resources Found
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Title:   Composition of Ginkgo Biloba products
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA has recently conducted testing on twenty-two (22) batches of medicines, covering twenty (20) products, and a number of associated Ginkgo extract raw materials.
Date:   Oct 2009
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:   Jul 2009
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 2009
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:   Jul 2009
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:   Jul 2009
Title:   TGA Office of Laboratories and Scientific Services
Publisher:   Australian Government Department of Health and Ageing
Description:   Information on the role, organisation, and activities of the TGA Office of Laboratories and Scientific Services.
Date:   Jun 2009
Title:   Surrogate outcome markers in research and clinical practice
Publisher:   Australian Prescriber
Description:   There are some valid surrogate markers of disease progression which can be reliably used to monitor chronic conditions, and as treatment goals. However, the clinical utility of many surrogates is open to question and their validity is largely untested.
Date:   Apr 2009
Title:   Controlling complementary medicine claims
Publisher:   Australian Prescriber
Description:   Despite the widespread and increasing use of complementary medicines, few of these products have been evaluated for efficacy or therapeutic equivalence.
Date:   Dec 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:   Oct 2008
Title:   Media statement - Scheduling of zolpidem (Stilnox)
Publisher:   Australian Government Department of Health and Ageing
Description:   The National Drugs and Poisons Schedule Committee (NDPSC) considered the scheduling of zolpidem (contained in the medicine Stilnox) at its February 2008 meeting, held this week, because of concerns relating to reports of potential abuse of this substance.
Date:   Feb 2008
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:   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:   Transparency - in the eye of the beholder?
Publisher:   Australian Prescriber
Description:   The Editorial Executive Committee of the Australian Prescriber express their concern about the increasing difficulty of obtaining good information on new drugs.
Date:   Aug 2005
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
Title:   The secrecy of drug regulatory information (Editorial)
Publisher:   Australian Prescriber
Description:   Can some reconciliation be achieved between the potential public benefit available from the release of currently confidential drug regulatory information, and the understandable commercial and possibly individual wish for continued secrecy of this information?
Date:   Aug 2002
Title:   Treatment of multiple sclerosis with newer immune-modulating drugs
Publisher:   Australian Prescriber
Description:   Multiple sclerosis can be a severely disabling disease. Recently introduced immunomodulatory drugs (interferon beta or glatiramer acetate) should be considered for the treatment of patients in the earlier stages of the disease, if they have a relapsing-remitting course.
Date:   Feb 2002
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