PMID: 9162429Jan 1, 1997Paper

Plasma-derived products: therapeutic biological products

Transfusion clinique et biologique : journal de la Société française de transfusion sanguine
G Folléa, J P Cazenave

Abstract

The status of proprietary medicinal product has been conferred upon plasma derived products (PDP) by the European Community in its directive issued on the 14 of June 1989. This directive requires each Member State to comply with the current regulations applicable to medicinal products related to production, control and registration of PDP. A different evolution characterized the American regulation in which PDP have been classified as biological products, submitted to a particular regulation since 1992. These different conceptions led the authors to systematically review the specificities of PDP in comparison to classical medicinal products: plasmatic raw material, production of active ingredients and manufacturing of products in the same facility, divergent production of several products from a single starting material, infection risks and variability characterizing biological products, registration and distribution. The analysis of complementary regulation issued to adapt the pharmaceutical principles to the PDP shows that it does not provide all the expected answers to the specificities of the PDP. This shows the advantages that could be expected by giving a status of biological therapeutic product to the PDP. This could abo...Continue Reading

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