An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency

Abstract

Results suggest there is no clear evidence that Swissmedic was substantially different in its initial regulatory decisions or SPC recommendations compared with the EMA or FDA.

A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA

“…First, regulatory decisions depend to some extent on the timing of MMA filing. SMC tends to receive MAA later than the EMA or the FDA 12 and as consequence the body of evidence regarding safety and efficacy submitted to SMC might be slightly more comprehensive compared to earlier filings at the EMA or FDA. Although the timing might therefore play a role, a preliminary analysis of our data at least gave no indication that SMC regulatory decisions were biased by EMA or FDA decisions known to SMC at the time point that decisions were made (data not shown).…”

“…This issue was recently addressed by Dörr et al, showing that the majority of initial labeling differences resulted from writing styles or structures of the Summary of Product Characteristics (SmPC) and were actually not clinically relevant. 12 Accordingly, the effect on MAA decisions should be minor.…”

Finding the way forward: COVID-19 vaccination progress in Germany, Austria and Switzerland

“…Switzerland, on the other hand, has its own regulatory agency called Swissmedic which governs their available pharmaceutical products and has historically had longer median approval times for new products (480 days) compared to the EMA (416 days). [8] Unsurprisingly, these fundamental institutional differences led to some variation in the approval timelines for the four principal vaccines that were deployed across Europe from the companies Pfizer-BioNTech (Pfizer), Moderna, AstraZeneca and Jansen.…”

The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study

“…Regulatory authorities have sought to address these challenges by strengthening the collaboration between them as well as with industry, and by developing guidelines for antibiotics addressing areas of important need [11][12][13][14][15][16][17][18][19]. Regulatory authorities have a high concordance when approving antibiotics and have become more harmonized with respect to approval time, but differences are still seen concerning target indications and decisions to conduct priority review/accelerated assessment [20][21][22][23][24][25][26][27][28].…”