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.
