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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). 

Technical Cooperation

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

Regional meeting on regulation of biotechnological products – First meeting of the biological/biotechnological products PANDRH working group in Punta Cana, Dominican Republic. 15– 17, June 2010

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). 

Working Group on Biological/biotechnological products 

Working Group on Vaccines

Reated topics

Essential Medicines and Biologicals

Evaluation of Essential Medicines, Vaccines, and Biologicals in Support of the Strategic Fund

Regional Network of National Vaccine Quality Control Laboratories (RRLNCCV)

Blood Services

Laboratory Services

 

Last Updated on Thursday, 18 August 2011 06:02

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