Drug Standards and Best Practice

Links to information about drug manufacturing standards, benchmarking and best practice, including codes of conduct, and international agreements.

 

Updated April 2008

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40 Resources Found
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Title:   TGA - Therapeutic Goods Administration
Publisher:   Australian Government Department of Health and Ageing
Description:   Home page of Therapeutic Goods Administration (TGA). TGA is Australia's regulatory agency for medical drugs and devices.
Date:   Aug 2008
Title:   European Union guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   Lists of European Union Guidelines relating to medicines, both those published as adopted in Australia and those published as not adopted in Australia.
Date:   Aug 2008
Title:   TGA news
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to issues of the TGA News, the official newsletter of the Therapeutic Goods Administration.
Date:   Jul 2008
Title:   Therapeutic Goods Committee (TGC)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Committee advises the Minister on standards for therapeutic goods, including labelling and packaging, and on principles to be observed in the manufacture of therapeutic goods for use in humans.
Date:   Jul 2008
Title:   Office of Chemical Safety
Publisher:   Australian Government Department of Health and Ageing
Description:   The Office of Chemical Safety provides advice on potential public health risks posed by chemicals used in the community.
Date:   Jan 2008
Title:   Common technical document (CTD)
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA currently accepts applications to register prescription medicines in both the old European Union (EU) format and the new Common Technical Document (CTD) format.
Date:   Jan 2008
Title:   International activities, agreements and information
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to information on international activities, agreements and international regulatory agencies
Date:   Jan 2008
Title:   Medicines Australia Code of Conduct: breaches
Publisher:   Australian Prescriber
Description:   Medicines Australia has a Code of Conduct to guide the promotion of prescription drugs by pharmaceutical companies in Australia. A new edition of the Code has recently been approved. Complaints are considered by the Code of Conduct Committee and the results are published in its annual report.
Date:   Dec 2007
Title:   Relationships between health professionals and industry: maintaining a delicate balance
Publisher:   Australian Prescriber
Description:   The power and influence of the pharmaceutical industry has raised concerns among health professionals and the wider community and led to calls for increased regulation. Overwhelming evidence that advertising, contact with company representatives, gift giving, sponsorship of meetings and other forms of promotion influence prescribing behaviour, has drawn particular attention to drug promotion.
Date:   Dec 2007
Title:   A guide to labelling drugs and poisons
Publisher:   Australian Government Department of Health and Ageing
Description:   This guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the harmonised requirements as they exist on 1 July 2000.
Date:   Oct 2007
Title:   Classification of Deficiencies (medicinal product manufacturers)
Publisher:   Australian Government Department of Health and Ageing
Description:   The GMP Audit and Licensing Section now classifies deficiencies (previously referred to as nonconformities) observed during GMP audits of medicinal product manufacturers as critical, major and other.
Date:   Aug 2007
Title:   Educational outreach visits: effects on professional practice and health care outcomes
Publisher:   John Wiley and Sons, Ltd. for The Cochrane Collaboration
Description:   This review found 69 studies that evaluated educational outreach visits. Educational outreach visits appear to improve the care delivered to patients. When trying to change how health care professionals prescribe medications, outreach visits consisten...
Date:   Aug 2007
Title:   Compositional guidelines
Publisher:   Australian Government Department of Health and Ageing
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.
Date:   Jul 2007
Title:   Australia-Singapore MRA on conformity assessment
Publisher:   Australian Government Department of Health and Ageing
Description:   A mutual recognition agreement (MRA) on conformity assessment between Australia and Singapore was signed in Canberra on 26 February 2001.
Date:   Jul 2006
Title:   Australia - European Free Trade Association mutual recognition agreement (EFTA-MRA)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Australia-EFTA Mutual Recognition Agreement (MRA) is an Agreement of treaty status, which has been negotiated on terms, which are almost identical to the Australia-European Community MRA on conformity assessment (EC-MRA) with some minor variations.
Date:   Jul 2006
Title:   Australia - European Community mutual recognition agreement (EC-MRA)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Mutual Recognition Agreement (MRA) on standards and conformity assessment between Australia and the European Community (EC) was signed in Canberra on 24 June 1998 and came into effect on 1 January 1999.
Date:   Jul 2006
Title:   Consolidated advisory statement requirements for medicine labels - Consultation document
Publisher:   Australian Government Department of Health and Ageing
Description:   The consultation document Consolidated Advisory Statement Requirements for Medicine Labels (CASRML) consolidates all Australian label advisory statement requirements for medicines in one place.
Date:   May 2006
Title:   TGA Office of Medicines Safety Monitoring
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescription medicines, vaccines, OTC medicines and complementary medicines.
Date:   Feb 2006
Title:   Australian regulatory guidelines for complementary medicines (ARGCM)
Publisher:   Australian Government Department of Health and Ageing
Description:   The content of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) is intended to reflect the current Australian requirements for the regulation of complementary medicines.
Date:   Nov 2005
Title:   Chemicals and public health - an information brochure on the assessment of toxicity
Publisher:   Australian Government Department of Health and Ageing
Description:   This brochure explains how public health is protected through the study of the toxicity of chemicals and their potential to cause adverse effects on humans; and how this information is used in the development of exposure standards to ensure that health risks are minimised.
Date:   Dec 2004
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