Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Close this folderAccess to drugs and vaccines I
View the documentGeneric medicines: old problems and new challenges from a European perspective
View the documentAccess to quality pharmaceuticals: the Indian experience
View the documentQuality of starting materials for drugs and vaccines
View the documentFixed-combination medicines: an Australian perspective
View the documentDrugs for neglected diseases: challenges for regulators
View the documentRecommendations
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover

Fixed-combination medicines: an Australian perspective

Dr Leonie Hunt, Australia

Australia has an independent regulatory system, which covers premarket assessment, pharmacovigilance programmes, the use of standards, enforcement of GMP requirements, a register of approved goods, and clinical trials. Independent expert advisory committees have been used extensively to provide guidance for decisions. For medicine regulations, there are the Australian Guidelines for Registration of Drugs. International guidelines are adopted whenever appropriate.

Fixed-combination products are important tools in therapeutic regimes. They may have a number of potential advantages over single therapies, including greater effectiveness, improved safety profile and simpler therapy. However, there are also potential disadvantages. As the formulation is fixed, doses cannot be easily adjusted to meet the needs of individual patients. For patients who are well controlled by single therapies, fixed combinations may give unnecessary exposure to a second medicine. Furthermore, there are additional adverse events. Therefore, justification is needed for each particular fixed-combination product, and the development of such a product should address the issues of the benefit and risk of the combination. Justification should take into account effectiveness, safety and improved compliance.

Fixed combinations must be of acceptable quality and logical combination. Moreover, the effect of interactions, within or outside the combination, on the pharmacodynamics and pharmacokinetics, should be investigated. In Australia, it is generally recommended that new combinations should be used as an add-on to single therapy, unless it can be demonstrated that use of the combination drug as first-line treatment is optimal. The minimum effective dose and maximal dose response should be established for the drugs used alone and in combination. The efficacy of the combination should be compared with the effective doses of the medicines alone, other reference therapies, and placebo. Finally, animal studies should have been performed and human data are required, for the medicines administered singly and in combination, to ensure safety.

In summary, fixed-dose combinations offer potential advantages to patients but are not always appropriate or rational. Careful selection of the medicines to be used, and assessment of use of the combination, are required to maximize the benefit.

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