|
Links to information about drug manufacturing standards, benchmarking and best practice, including codes of conduct, and international agreements.
Updated April 2008
Printer friendly page
| Results 1 to 20 displayed. |
|
1
2
|
| 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: |
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: |
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
|
| Results 1 to 20 displayed. |
|
1
2
|
|