The process of completing clinical testing and obtaining regulatory approval for a new drug product require many years, substantial capital and other resources. Research and development activities are subject to significant regulation by various governmental authorities.

Curaderm and Curaderm BEC5 have attained all the necessary requirements to allow their registration by various health authorities.

Curaderm has obtained regulatory approval by the Therapeutic Goods Administration in Australia for the indications of solar keratoses and was scheduled as an S4 item prescription only.

Subsequently, regulatory approval from the Ministry of Health by the Government of the Republic of Vanuatu was obtained for the Medicine Registration of Curaderm BEC5 for the indications of non melanoma skin cancers: keratoses, keratoacanthomas, basal cell and squamous cell carcinomas.

The Curaderm BEC5 Therapeutic Goods is classified as Schedule 1 which means that the sale of Curaderm BEC5 is unrestricted and may be sold without prescription.

This rendered the TGA registration superfluous and it was decided to discontinue the registration of Curaderm with the TGA and to retain the more widely applicable registration in the Republic of Vanuatu.