Guidelines for Registration of Bio-therapeutic Protein Products

The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated by the proclamation No . 661/2009 to ensure the safety, quality and efficacy of medicines. Biotherapeutic protein products prepared by recombinant deoxyribonucleic acid technology (rDNA-derived biotherapeutics) are pharmaceutical products that fall in this jurisdiction that must be available in the market of Ethiopia of required safety, quality and effectiveness. Recombinant DNA-derived biotherapeutics are products of biological origin that exhibit some intrinsic variability. They are characterized by complex manufacturing processes. The quality of those products cannot be assessed solely by testing the final product alone. Hence, Specific regulatory systems should also be strengthened. This Guideline is intended to provide guidance to the applicants on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant deoxyribonucleic acid (DNA) technology (rDNA-derived biotherapeutics) and intended for use in humans. Part A of this guideline sets out guidance for the manufacture and quality control of rDNAderived biotherapeutics, including consideration of the effects of manufacturing changes and of devices used in the delivery of the product and in its stability. Part B provides guidance on nonclinical evaluation, while Part C provides guidance on clinical evaluation. The nature and extent of characterization and testing (Part A) required for a product undergoing nonclinical and clinical studies will vary according to the nature of the product and its stage of development. The legal status of investigational products varies from country to country. The need for and extent of studies (e.g. on characterization) will depend on the product under consideration. This specific guideline is prepared to capture the requirements specific to the rDNA-derived biotherapeutics products and align to the international standards (WHO) and ICH guidelines. Applicants are highly recommended to compile the dossier according to Common Technical Documents (CTD). This guideline also set the requirements for rDNA-derived biotherapeutics who qualify the under Stringent Regulatory Authority (SRA) procedure as indicated in Annex IV of this guideline.