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Links to information about medicines and drug manufacturing standards, benchmarking and best practice, including codes of conduct, and international agreements.
Updated May 2009
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| Title: |
Manufacturing principles - new/amended requirements
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Adoption of the January 2009 PIC/S GMP Guide For Medicines as a Manufacturing Principle - new or amended GMP requirements
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| Date: |
Sep 2009
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| Title: |
Updated manufacturing principles for medicinal products
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
On 29 July 2009 the TGA National Manager determined new principles to be observed for manufacturers of medicinal products (including active pharmaceutical ingredients and sunscreen products) under Section 36(1) of the Therapeutic Goods Act 1989.
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| Date: |
Jul 2009
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| Title: |
TGA - Therapeutic Goods Administration
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Home page of Therapeutic Goods Administration (TGA). TGA is Australia's regulatory agency for medical drugs and devices.
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| Date: |
Jul 2009
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| Title: |
European Union guidelines
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Lists of European Union Guidelines relating to medicines, both those published as adopted in Australia and those published as not adopted in Australia.
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| Date: |
Jul 2009
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| Title: |
Questions and answers relating to the additional default standards legislation
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 amends the Therapeutic Goods Act 1989 (the Act) in relation to standards applying to medicines and other therapeutic goods that are not medical devices.
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| Date: |
Jun 2009
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| Title: |
Office of Chemical Safety and Environmental Health (OCSEH)
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Office of Chemical Safety and Environmental Health (OCSEH), part of the Office of Health Protection within the Australian Government Department of Health and Ageing, is responsible for human health risk assessment policy and practice for veterinary medicines, pesticides and other environmental chemicals.
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| Date: |
Jun 2009
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| Title: |
Technical working groups
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Technical Working Groups (TWG) have been established by the TGA's Office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise from industry and the regulator to address the grey areas or vagaries of the cGMP as it relates to manufacturing.
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| Date: |
May 2009
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| Title: |
TGA news
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
Links to issues of the TGA News, the official newsletter of the Therapeutic Goods Administration.
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| Date: |
Apr 2009
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| Title: |
Therapeutic Goods Committee (TGC)
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Mar 2009
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| Title: |
Common technical document (CTD)
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Jan 2009
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| Title: |
Tamper-evident packaging
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
The Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Edition 1, June 2003) has been developed under the direction of the Industry Government Crisis Management Committee (IGCMC), through its Subcommittee on Tamper-Evident Packaging.
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| Date: |
Dec 2008
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| Title: |
Relationships between health professionals and industry: maintaining a delicate balance
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| Publisher: |
Australian Prescriber
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| 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.
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| Date: |
Dec 2007
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| Title: |
Medicines Australia Code of Conduct: breaches
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| Publisher: |
Australian Prescriber
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| 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.
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| Date: |
Dec 2007
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| Title: |
A guide to labelling drugs and poisons
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Oct 2007
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| Title: |
Classification of Deficiencies (medicinal product manufacturers)
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Aug 2007
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| Title: |
Educational outreach visits: effects on professional practice and health care outcomes
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| Publisher: |
John Wiley and Sons, Ltd. for The Cochrane Collaboration
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| Description: |
There have been many ways developed to improve how health care professionals care for their patients. One way to improve how health care professionals practice is to provide educational outreach visits. Trained people visit clinicians where they practic...
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| Date: |
Aug 2007
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| Title: |
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: |
Jul 2007
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| Title: |
Australia-Singapore MRA on conformity assessment
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| Publisher: |
Australian Government Department of Health and Ageing
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| Description: |
A mutual recognition agreement (MRA) on conformity assessment between Australia and Singapore was signed in Canberra on 26 February 2001.
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| Date: |
Jul 2006
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| Title: |
Australia - European Free Trade Association mutual recognition agreement (EFTA-MRA)
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| Publisher: |
Australian Government Department of Health and Ageing
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| 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.
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| Date: |
Jul 2006
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