SUDA has engaged with the WHO in relation to the optimal regulatory strategy that would facilitate the inclusion of ArTiMist™ in the WHO Guidelines for the Treatment of Malaria.
The WHO Guidelines are generally adopted by national healthcare agencies in malaria-endemic countries and are used as the basis for large-scale procurement of medicines for public health use.
The WHO has recommended that SUDA firstly seek registration of ArTiMist™ with the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) under Article 58. Article 58 of Regulation (EC) No 726/2004 allows the EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the WHO, on medicinal products for human use that are intended exclusively for markets outside of the European Union
As you will see there was no mention of TGA - but FDA and EMA where the two mentioned by WHO>
To add to the fact that SUDA decided to submit a MAA via TGA and not FDA or EMA is the fact that WHO do not have any say in the approval time of the MAA - which provided SUDA had followed the correct process, responded to questions within the allotted time and paid the prescribed fees then the approval or otherwise should not take more than 12 months - from all I have read on the approval process if the company submitting the MAA follow the guidelines and make the payment on time there is no way that TGA can hold up the process - in other words any delays can only be caused by the submitting company
SUD Price at posting:
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