It seems that interest is growing for starting Phase 1 trials in Australia due in part to the comparative ease of regulatory submission, the scientific confidence in the results and the lower costs. There is quite a bit of regulatory history in Australia that might contribute to a combination of adherence to good clinical practices and favorable regulatory procedures.
Australia started regulating pharmaceutical products in 1969 after some patients in a Melbourne Hospital were treated with Thalidomide for actinic prurigo, prurigo nodularis, lupus erythematosus and Behçet's syndrome. The adverse effects of Thalidomide on patients prompted authorities to make regulations to monitor toxicity of such medicines. This experience contributed to the genesis of pharmaceutical regulations in Australia.
Australia set up a regulatory agency called Therapeutic Goods Administration (TGA) to check the quality and safety of the medicines that were marketed in Australia even before it harmonized its regulations with that of the International GMP. The TGA monitors the quality and safety of the therapeutic products in two ways: by issuing a license when the product passed the first testing and through laboratory tests by taking samples off the shelf to study unfavorable or harmful reactions to medications. The TGA’s framework is based on the European model and they periodically benchmark themselves against other developed nations. In the last few years the TGA and the National Health and Medical Research Council (NHMRC) jointly established a Review of the Australian Arrangements for Clinical Trials & Access to Unapproved Therapeutic Goods.
It appears that the total cost of conducting clinical trials is in Australia is lower than in the US for several reasons. One reason is that preparing a regulatory application to start a trial in Australia is akin to filing a Clinical Trial Application in Europe. This is less involved than filing an IND in the US. Generally, the same amount of non-clinical, safety and CMC efforts are the same, but writing up the application for Australia takes less effort than preparing a US IND. Another reason is that clinical trials can be performed more economically due to the exchange rate of the U.S. dollar and the Euro that favors Australia, plus the cost of medical procedures and investigator fees are lower. This may explain why some companies in the US are contemplating conducting early stage clinical trials in Australia.
Regulatory Affairs at PharmaDirections
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