Abstract:
Ethiopia has been made huge strides to improve access to safe, quality and efficacious medicines
to the public. The Ethiopian Food, Medicine and Healthcare Administration and Control
Authority is responsible to ensure the safety, quality and effectiveness of biotherapeutic protein
products prepared by recombinant deoxyribonucleic acid technology (rDNA-derived
biotherapeutics). These products are pharmaceutical products that fall in this jurisdiction and
must be regulated as stipulated in the proclamation No. 661/2009.
