Licensing

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.

How to license vaccines against new and emerging infectious diseases fast and effective?

Recent past has repeatedly taught us that influenza pandemics probably no longer constitute an immediate health threat for the global population. Other infectious diseases have caught up outnumbering pandemic influenza in number and sequence of events. WHO and other public health institutions regularly report on outbreaks mainly caused by viral infectious agents such as MERS, SARS, West Nile Flavivirus (WNV), Ebola, Chikungunya, Zika, Dengue viruses and so on. Barely any of these infectious diseases is preventable by vaccination and none of them is curable by antiviral treatment. Although regulatory authorities offer all their support to facilitate development and licensure of safe and effective vaccines against these diseases there are, with one exception, no appropriate vaccines licensed and available.