BioWorld International Correspondent
BRUSSELS, Belgium - The biotechnology working party at the European Union's Agency for the Evaluation of Medicinal Products in London has agreed on a heavy schedule as part of its 2004 work plan, finalized Dec. 21. During the monthly meetings it has planned throughout 2004 (except in August), it will aim to produce some 50 new guidance documents on detailed aspects of production and marketing of biotechnology-derived medicines.
The working party also expects to be involved in the assessment of marketing authorization applications for 24 new biotech-derived products, to give scientific advice or protocol assistance to companies in the preparation of 20 applications and to be involved in the post-marketing assessment of 24 products.
The guidance documents will include 12 on the production of biotechnological medicines, nine on vaccines, three on gene and cell therapy, two on animal spongiform encephalopathies, and four on plasma-derived medicinal products. The topics to be covered range from viral safety to the comparability of medicines containing biotechnology-derived proteins, and from the use of transgenic plants in new medicines to the manufacture and control of recombinant allergens.
The working party will be entitled to call on experts from the EU and beyond, and from industry as well as from regulatory authorities. The new EU rules on pharmaceuticals are expected to be finalized shortly - and to come into effect as early as February or March of next year.