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Guidelines for registration of biotherapeutic protein products prepared by recombinant DNA technology

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dc.contributor.author Ethiopian Food and Drug Authority
dc.date.accessioned 2023-12-27T06:27:07Z
dc.date.available 2023-12-27T06:27:07Z
dc.date.issued 2018
dc.identifier.uri http://repository.iphce.org/xmlui/handle/123456789/2658
dc.description.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. en_US
dc.language.iso English en_US
dc.subject Health information technology & information management en_US
dc.title Guidelines for registration of biotherapeutic protein products prepared by recombinant DNA technology en_US
dc.type Guideline en_US


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