Drug Standards and Best Practice

Follow the links below to find information about medicines and drug manufacturing standards, benchmarking and best practice, including codes of conduct, and international agreements.

Reviewed September 2011

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39 Resources Found

Results 1 to 20 displayed.     1  2 

Title:   Therapeutic Goods Administration (TGA)
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:   Mar 2012
Title:   Australian regulatory guidelines for complementary medicines (ARGCM)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) is reflects the current Australian requirements for the regulation of complementary medicines
Date:   Mar 2012
Title:   Office of Chemical Safety
Publisher:   Australian Government Department of Health and Ageing
Description:   The Office of Chemical Safety (OCS) is responsible for human health risk assessment policy and practice for veterinary medicines and pesticides. OCS is responsible for ensuring that Australia fulfils its obligations under international agreements relating to the regulation of chemicals and for collecting statistics about chemicals.
Date:   Jan 2012
Title:   Therapeutic Goods Committee (TGC)
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGC 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:   Dec 2011
Title:   Medicines Australia Code of Conduct: breaches
Publisher:   Australian Prescriber
Description:   The Medicines Australia Code of Conduct guides the promotion of prescription products by pharmaceutical companies.
Date:   Nov 2011
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 TGA approves for use in listed medicines
Date:   Nov 2011
Title:   Technical working groups
Publisher:   Australian Government Department of Health and Ageing
Description:   Technical Working Groups have been established 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
Date:   Jun 2011
Title:   Common technical document (CTD)
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA only accepts applications to register prescription medicines in the Common Technical Document (CTD) format
Date:   May 2011
Title:   Colourings permitted in medicines for oral use
Publisher:   Australian Government Department of Health and Ageing
Description:   List of colourings permitted in complementary, OTC and prescription medicines for oral use and provides indicative data requirements for the evaluation of new colours for inclusion in medicines for oral use
Date:   May 2011
Title:   International
Publisher:   Australian Government Department of Health and Ageing
Description:   Information about the TGA's international activities and links to international organisations involved in the regulation of therapeutic goods.
Date:   Apr 2011
Title:   OLSS international affiliations & activities
Publisher:   Australian Government Department of Health and Ageing
Description:   As an integral part of the regulatory process, TGA's Office of Laboratories and Scientific Services staff are involved in the development of standards for therapeutic goods, at both national and international levels
Date:   Apr 2011
Title:   Newsletters & articles
Publisher:   Australian Government Department of Health and Ageing
Description:   Newsletters and articles produced by the TGA
Date:   Mar 2011
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:   Mar 2011
Title:   Questions & answers relating to the additional default standards legislation
Publisher:   Australian Government Department of Health and Ageing
Description:   'Default standard' means any of the British Pharmacopoeia (BP), European Pharmacopoeia (Ph Eur), and United States Pharmacopoeia-National Formulary (USP)
Date:   Feb 2011
Title:   Medicines Australia Code of Conduct: breaches
Publisher:   Australian Prescriber
Description:   The Medicines Australia Code of Conduct guides the promotion of prescription products by pharmaceutical companies.1 Each year Medicines Australia publishes a report, from its Code of Conduct Committee, which details all the complaints that have been received about advertising and other promotional activities.
Date:   Dec 2010
Title:   Audit of medicine manufacturers
Publisher:   Australian Government Department of Health and Ageing
Description:   With certain exceptions, manufacturers of therapeutic goods in Australia are required under the Therapeutic Goods Act 1989 to hold a licence
Date:   Nov 2010
Title:   Draft Australian regulatory guidelines for GMP clearance for overseas manufacturers
Publisher:   Australian Government Department of Health and Ageing
Description:   Invitation t sponsors and manufacturers to comment on a revision of the guidance document provided by the TGA for the assessment of GMP compliance for overseas manufacturing sites
Date:   Nov 2010
Title:   Australian code of good wholesaling practice for medicines in Schedules 2, 3, 4 & 8
Publisher:   Australian Government Department of Health and Ageing
Description:   This Code of Practice is concerned with ensuring that quality is maintained during wholesaling and it sets out appropriate standards to be applied
Date:   Oct 2010
Title:   Questions & answers on the code of good manufacturing practice for medicinal products
Publisher:   Australian Government Department of Health and Ageing
Description:   Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009 determines the PIC/S Guide to Good Manufacturing Practice, 15 January 2009, PE 009-8, to be the Code of GMP, except for its Annexes 4, 5 and 14 which are not adopted by Australia
Date:   Oct 2010
Title:   Australian Code of Good Manufacturing Practice for Medicinal Products
Publisher:   Australian Government Department of Health and Ageing
Description:   On 29 July 2009, the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009 adopted the PIC/S Guide to Good Manufacturing Practice - 15 January 2009, PE 009-8, to be the Code of GMP, except for its Annexes 4, 5 and 14 which are not adopted by Australia
Date:   Jul 2010

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