Australia, submission requirement

This essay reviews the submission requirements for the four markets of greatest interest to American companies Canada, Australia, Japan, and the European Union (EU). Finally, the latest update on the International Conference on Flarmonization (ICFI) and attempts at harmonization is included. 

The type of submission considered by DSEB to be appropriate for a PI update depends on the regulatory and clinical history of the drug in Australia and overseas, with special reference to the United Kingdom, United States, Sweden, Canada and the Netherlands. Submissions based on company sponsored clinical trials are usually required for drugs marketed for less than 5 years, whereas any of the three types of submission can be used for drugs marketed for more than 10 years. Drugs marketed between 5 and 10 years will be considered on a case by case basis, but it is generally expected that either a conventional or hybrid submission will be submitted. 

Currently, AHEC is working with HRECs around Australia to develop a nationally accepted clinical trial application format that will be acceptable to all HRECs. This will significantly benefit sponsors of clinical trials who currently have to prepare applications in different formats to meet individual HREC requirements, which delays submission of applications in Australia and adds to the workload. 

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