Guideline for registration of oral care and skin care products with therapeutic claims

Abstract

The Ethiopian Food and Drug Authority (EFDA) is mandated by the proclamation No.1112/2019 to ensure the safety, efficacy and quality as well as rational use of medicines. Article 19 (1) of the proclamation decrees that “the rigor of regulatory assessment of medicines and medical devices shall be commensurate with the products type, nature and potential risk to human health”. The evaluation process to ensure safety, efficacy and quality of skin care and oral care products with therapeutic claim, which are preventive in nature, needs a relatively minimum exertion to ease the accessibility of the products for consumers use. Marketing authorization applications for skincare and oral care products with therapeutic claim are one of the category of pharmaceuticals that fall in the jurisdiction that permits shortened assessment as they are generally considered as the least risky therapeutic products that needs marketing authorization for marketing in Ethiopia.