Swissmedic

Switzerland's agency for therapeutic products.

National agencySwitzerlandBern, SwitzerlandEst. 2002Website

iUmbrella term for any formal request sent to companies — an RFI, RFP or RFQ.Save Claim this listingOpen roomCompare Report

OverviewRegulatory scopePrograms & pathwaysGuidance & approvalsAgency structure

Approval programs & pathways

2 programs · 2 pathways

Expedited / special pathways

Fast TrackRolling ReviewOrphan DrugConditional Approval

Fast TrackExpedited

Fast-track authorisation for serious diseases.

Eligibility · Serious disease + benefit

Orphan DrugOrphan

Orphan-drug status incentives.

Eligibility · Rare disease

Submission pathways · illustrative timelines & fees

CTA1 mo

Biologics · Agency fee

Clinical trial authorisation in Switzerland.

MAA13 mo

Small molecules · Agency fee

Marketing authorisation application.

Swissmedic

Swissmedic

National agency · Switzerland

Live record · illustrative seed data · scores deterministic, rules-based — not AI.