Consideration of Alternative Licensing Procedures for Vaccines for Minor Species and Minor Indications -Manufacturers' Point of View

摘要

The E.U. authorities, manufacturers and people in the field are well aware of the need for a smoother, less-demanding and more harmonised way of granting marketing authorisations for certain products. The authorities have already made some good proposals and this is a basis for discussion and moving ahead. In addition, most of the actors concerned in this process have already had some good (and bad) experiences on how the current system works (or not) in delivering timely authorisations to answer needs from the field, and this factor will also help. It must be noted that the set goal is quite ambitious. Once an agreement is reached on modified technical and regulatory requirements, it could be requested that both E.U. and national law/guidelines bemodified. Clearly this will be a very long process. Ceva's paper focuses on what could be the best use of current E.U. law for the registration of Minor Species and Minor Indications vaccines. Furthermore, based on first-hand experience, we will detail how the law could be applied in practical ways so that most of the needs are answered as soon as possible and with reasonable data package and registration procedures.