Guideline for registration of low-risk medicines

Abstract

The Ethiopian Food and Drug Authority (EFDA) is mandated by the Proclamation No. 1112/2019 to ensure safety, efficacy and quality as well as rational use of medicines. Article 19 sub-article 1 of the proclamation decrees that “the rigor of regulatory assessment of medicines shall be commensurate with the products type, nature and potential risk to human health”. Accordingly, the evaluation process to ensure safety, efficacy and quality of low risk medicines needs minimum exertion for effective utilization of limited resource and to ease the accessibility of the products for consumers. Products that are relatively safe and of proven efficacy; such as some over the counter (OTC) medicines, products fulfilling criteria for risk categorization of medicines set in this guideline are pharmaceutical products that fall in the jurisdiction that permits abbreviated assessment as they are generally considered as low risk products.