Following advancements in pharmaceutical innovations which has led to increase in the number of new biopharmaceutical drugs, the National Agency for Food and Drug Administration and Control (NAFDAC) has unfolded plans to develop a regulatory framework to ensure best practices in the manufacturing and marketing of this category of drugs.
The Director General of NAFDAC, Dr Paul Orhii outlined this new plans of the agency in Lagos at a capacity building workshop for NAFDAC officials on the science and regulation of Biopharmaceutical/Biosimilar drugs with aim of developing stringent guidelines for the care and control of such drugs.
According to the Director General of NAFDAC, who was represented at the occasion by the agency’s Director of Inspectorate, Mrs Hauwa Keri, biopharmaceutical drugs refers to drugs that have unique qualities due to the way they are derived and manufactured as opposed to traditional generic drugs.
He explained that such drugs are protein- based and can be derived from blood and plasma, adding that they represent a diverse group of products some of which include peptides and vaccines. An example is the insulin drug used by diabetic patients.
Orhii explained that following the diverse and rapidly expanding global market in new biopharmaceutical drugs, ‘there became an urgent need for a global development of new regulatory guidelines for this unique life- saving drugs”.