BioWorld International Correspondent

BRUSSELS, Belgium - The European Medicines Evaluation Agency has set out its plans on biotechnology for the next two years.

The agency's just-published work plan for 2001-02 lists a heavy workload for its biotechnology working party, ranging from the broad task of reviewing the quality aspects of marketing authorization applications for biological and biotechnological medicinal products to providing scientific advice. It also includes advising EU authorities on public health issues arising from the mad cow disease epidemic still threatening Europe, including transmissible spongiform encephalopathy, and blood product-related questions including Creutzfeldt-Jakob's Disease, viral safety and plasma derivatives used as excipients in medicinal products.

Among the detailed projects to be carried out over the next two years, the biotechnology working party is to review current guidelines on testing of biotechnology-derived medicines and to develop new ones, with attention focused on the use of transgenic animals and plants in the manufacture of biological medicines; and on the quality, preclinical and clinical aspects of gene transfer medicinal products, live-attenuated influenza vaccines, comparability of rDNA-derived medicines, immune sera of animal origin, human somatic cell therapy products and xenogenic cell therapy products.

"Looking ahead to the many new developments in medicines technology and the expected benefits of the human genome project, we will need to prepare ourselves to face the challenge of new and exciting therapies," said Thomas Lvnngren, the new executive director of the EMEA, when presenting his plans.