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.
