Guideline for registration of antiseptics and disinfectants

Abstract

The Ethiopian Food and Drug Authority (EFDA) is mandated by the proclamation No. 1112/2019 to register and undertake related regulatory assessment of antiseptics & disinfectants. 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”. Article number 28(2) of the same proclamation explicitly describes that “the registration and related regulatory assessment of antiseptics and disinfectants shall be commensurate with the products potential risk to human health”. Therefore, the evaluation process to ensure safety, quality and effectiveness of antiseptics and disinfectants, categorized as low pharmaceuticals, falls in the jurisdiction that permits abbreviated assessment of applications for granting marketing authorization.