In general, biological products are distinguished from other drugs by being derived from living organisms (ranging from normal or genetically modified microorganisms to fluids and tissues derived from various animal and human sources) and frequently have a complex molecular structure.
Biological products manufactured by these methods include allergens, antigens, vaccines, hormones, cytokines, enzymes, human whole blood and plasma derivatives, immune sera, immunoglobulins (including monoclonal antibodies), products of fermentation (including products derived from rDNA) and diagnostic agents for in vitro use. (Reference: World Health Organization).
To ensure consistency in the quality, safety, and efficacy of medicinal products derived from complex biological materials, emphasis must be placed on their standardized production and quality control testing.
One of the strategic objectives of PAHO Medicines and Health Technologies Project is to offer support to the national regulatory authorities that allows the member countries to develop, implement, and strengthen activities related to regulation of medicines, including vaccines and other biologicals
More information at Essential Medicines and Biologicals Webpage
Regulation of biotechnological products Regional Meetings
Reunión de Autoridades Nacionales Reguladoras de Productos Biológicos en Latino América y el Caribe “Productos Biológicos / Biotecnológicos”. República Dominicana 12 y 13 de junio de 2008. [Only in Spanish]
Pan American Network on Drug Regulatory Harmonization (PANDRH).
Essential Medicines and Biologicals
Regional Office for the Americas of the World Health Organization