EMA

EMA’s Article 58 procedure and WHO’s prequalification procedure – pathways to licensure worth to consider for vaccines and other medicinal products

by Michael Pfleiderer

There are challenges and opportunities for developers of vaccines and other medicinal products needed outside the EU but having a high potential of becoming essential medicinal products also within the EU. The Article 58 procedure is reserved for products that are not (or not yet) foreseen for EU markets. The EU Article 58 procedure and the WHO prequalification procedure have been revised and now provide excellent opportunities to drug manufacturers. In this article, Michael Pfleiderer provides a detailed overview on the Article 58 procedure and WHO’s prequalification procedure.