European project concerning the guidelines on medicinal products derived from human blood and plasma

The Biotechnology/Pharmacy Working Party (BPWP) decided in October 1989 to put on its working programme the elaboration of a guideline on medicinal products derived from human blood and plasma. This has been determined by the adoption of Directive 89/381/EEC extending the scope of the EEC pharmaceutical legislation to medicinal products derived from human plasma. Because Directive 89/381/EEC will come into force on 1 Jan. 1992, the existing products derived from plasma should be reviewed in order to harmonize them with the EEC requirements before 1 Jan. 1993. In this paper, I give an account of the main points and questions addressed by the BPWP draft in order to stimulate comments from producers and regulatory agencies.

Published by Developments in biological standardization, 1991. The guideline itself is at the source linked here.

pubmed.ncbi.nlm.nih.gov/1794627/