The TGA usually takes about 12 months to complete their review of a regulatory dossier. “We are progressing towards the submission of our regulatory dossier for ArTiMist® with the TGA in CY2016. This will be a significant milestone for SUDA and an important step towards large-scale access to our novel sublingual spray for children suffering with the disease in malaria-endemic countries.” In our discussions with the World Health Organisation regarding Pre-Qualification of ArTiMist®, one of their key requirements was for the product to be reviewed by one of the five major regulatory agencies across the world, which includes the TGA. Pre-Qualification by the WHO will ensure that ArTiMist® is available for the procurement of anti-malarial treatments by national and international agencies.
SELL & take, page-31
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