Masterarbeit

Access Consortium - New Active Substance Work-Sharing Initiative

Cornelia Erhard (2020)

Summary
Language: English
The aim of this master thesis is to provide an overview on the Access Consortium itself, with focus on the New Active Substance Work-Sharing Initiative (NASWSI).
The Access Consortium is a perfect example of a well working collaboration of mid-sized highly recognized and high quality regulatory health authorities. In a first part the Access Consortium is described regarding members, organization, different working groups as well as the pathway to build a work-sharing procedure with countries which are not geographically nor politically connected.
The NASWSI is described in detail concerning the procedure itself from pre-submission through evaluation until the end of procedure including topics such as timelines, fees, communication as well as challenges this new procedure brings along. In a next chapter the so far approved medicinal products via the NASWSI are listed and discussed. A comparison is made between the NASWSI and the regulatory approval procedures in general, median regulatory approval time and regulatory approval procedures of the NASWSI approved medicinal products. One approved medicinal product Xofluza is chosen as a case study and described in detail.
Finally considerations of choosing the NASWSI from the applicant and the regulatory health authorities point of view are discussed. In the end a conclusion and a general outlook of the Access Consortium especially regarding the NASWSI is given.
Pages: 43