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
Close this folderRegulatory challenges: health sector reform and drug regulatory capacity
View the documentStrengthening regulatory capacity during reform
View the documentThe creation of a trans-Tasman therapeutic products regulatory agency: a case study in cooperation
View the documentThe South African experience
View the documentDrug registration and importation control in Tunisia
View the documentHealth reform and drug regulation in Venezuela
View the documentEconomic regulation of pharmaceuticals in Brazil
View the documentRecommendations
Open this folder and view contentsAccess to drugs and vaccines I
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
 

The creation of a trans-Tasman therapeutic products regulatory agency: a case study in cooperation

Dr Stewart Jessamine, New Zealand, and Mr Graham Peachey, Australia

The creation of a joint trans-Tasman agency is intended to ensure that both Australia and New Zealand are able to manage the regulation of an expanding range of increasingly complex products, and to enhance the influence of each country in regional and global regulatory activities. It will also facilitate trans-Tasman trade.

Various models were considered for the collaboration, and it was concluded that a true joint agency, performing the full range of regulatory activities, was the preferred one. Discussions have been wide-ranging, covering issues of sovereignty, control of advertising of pharmaceuticals, and cost recovery. The governance principles have essentially been agreed by the regulatory authorities, but have yet to receive formal government endorsement.

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