Biosimilar Guidance Document (NAFDAC)
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
The intention of this document is to provide acceptable principles for the registration of biosimilar products that are claimed to be similar to RBP of assured quality, safety, and efficacy that have been licensed based on a full registration dossier by a stringent regulatory authority. On the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.
Process Flow
Biosimilar Guidance Document (NAFDAC) Current Version
January 2022
The intention of this document is to provide acceptable principles for the registration of biosimilar products that are claimed to be similar to RBP of assured quality, safety, and efficacy that have been licensed based on a full registration dossier by a stringent regulatory authority. On the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.
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