Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Between recognition, reliance, and lead. Will new Facilitated Regulatory Pathways (FRPs) have the potential to promote Swissmedic to a first wave agency? ***

Linda Krempl (Abschlußjahr: 2022)

Summary
Language: English
A 2019 study of the last decade on the submission gap, i.e. the time between the date of submission to the first regulatory authority and the date of submission to the target authority, showed that industry submits its New Active Substance (NAS) applications to Swissmedic several months after the so-called "first wave" authorities FDA and EMA.
Since Swissmedic, aims to play in the first wave league, this thesis evaluates, whether facilitated regulatory pathways (FRPS) can enable Swissmedic's advancement to a first wave authority. To address this question, the two main concepts of primary and secondary FRPs are explained and demonstrated using the applied FRPs of the two first wave authorities, FDA and EMA.
While primary FRPs accelerate assessment time by prioritizing resources within a single jurisdiction and accepting pre-approval abbreviated clinical data, secondary FRPs are characterized by the concept of sharing resources and expertise between two or more national authorities through the concept of reliance and recognition.
Subsequently, the primary FRPs (Procedure with Prior Notification (PPN), Fast-Track Authorisation Procedure (FTP), Temporary Authorisation for human medicinal products (TA)) and secondary FRPs (Authorisation under Article 13 TPA, Authorisation under Access Consortium, Authorisation under Orbis, Marketing Authorisation for Global Health Products (MAGHP)) currently used by Swissmedic are described and, where available, parallels with the two first-wave authorities FDA and EMA are highlighted. Particular attention is paid to the two newly introduced secondary FRPs, the Access Consortium's New Active Substance Work-Sharing Initiative (NASWSI) and the FDA's Orbis program, in which Swissmedic has participated since 2019.
Based on the characteristics of the FRPs used by Swissmedic, Swissmedic’s NAS approval statistics from 2020 and 2021, and the results of a benchmarking study by Swissmedic and industry, it was concluded that while the primary FRPs accelerate assessment time only, the newly introduced secondary FRPs (approval under Orbis and the Access Consortium) also have a positive impact to promote Swissmedic to the first wave.
It is therefore recommended, that Swissmedic does not further improve their national primary FRPs, but enforce secondary FRPs, international collaboration programs based on recognition, reliance and lead.
Pages: 55