Last update: 11 March 2014
The regulatory body for approval of medicines in Nigeria is the National Agency for Food and Drugs Administration and Control (NAFDAC). The agency, through its Regulatory and Registration Directorate, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Nigeria.
Medicinal products cannot be manufactured, imported, exported, advertised, sold or distributed in Nigeria until they have been registered in accordance with the provisions of Decree 19 of 1993 as amended by Food, Drugs and Related Products (Registration) Decree No. 20 of 1999.
NAFDAC issued a guideline regarding the regulation of biosimilar products in December 2012. The NAFDAC guideline is an overarching guideline covering general considerations for biosimilar approval, such as selection of the reference drug, labelling requirements and fees.
NAFDAC has the following guidelines regarding biosimilars:
1. Overarching Guideline
This guideline covers all biosimilar products:
Guidelines for the registration of biosimilars in Nigeria
Date: December 2012
The guideline defines a biosimilar as a product that demonstrates similarity in terms of quality, safety and efficacy to a named reference biotherapeutic product licensed in Nigeria and/or by a stringent regulatory authority.
It should be noted that ‘biosimilars’ approved in Nigeria might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
EU guidelines for biosimilars
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