Guideline for registration of monoclonal antibodies and related products

dc.contributor.author	Ethiopian Food and Drug Authority
dc.date.accessioned	2026-02-24T08:40:24Z
dc.date.available	2026-02-24T08:40:24Z
dc.date.issued	2025
dc.identifier.uri	http://repository.iphce.org/xmlui/handle/123456789/5345
dc.description.abstract	The Ethiopia Food and Drug Authority (EFDA) is responsible for ensuring the safety, efficacy, and quality of medicines in Ethiopia, as mandated by the Food and Medicine Administration Proclamation No. 1112/2019. Article 19(1) of the proclamation states that the rigor of regulatory assessment shall commensurate with the type, nature, and potential risk of the product to human health.	en_US
dc.language.iso	en_US	en_US
dc.subject	Medical supplies	en_US
dc.title	Guideline for registration of monoclonal antibodies and related products	en_US
dc.type	Guideline	en_US