How new drugs, biologics, biosimilars, generics, over-the-counter medicines, vaccines, cell and gene therapies, combination products, medical devices, diagnostics and medical software get approved: the steps, requirements, official time targets, fees and reliance routes of each pathway.
Open the interactive pathway explorer with flowcharts, timelines, the reliance network, the world map and approvals charts.
Markets with pages
20
24 markets covered
Reviewed pathways
435
Routes, programs, designations
Approvals in the data
738,866
Official regulator data
Last verified
October 3, 2026
Most recent content check
Each page lists every reviewed route of the market
Two markets side by side, route by route
A regulatory pathway is the legal route a medicine or medical device takes to be allowed on a market: who reviews it, what data must be filed, the steps and official time targets, and the fees. Most markets have several routes, for example a full application for a new medicine, a shorter route for generics, faster programs for serious diseases and reliance routes that use another regulator's approval.
Every local route is mapped to a shared list of 28 pathway types, such as full application for a new active substance, generic, biosimilar, conditional approval, priority review, reliance, premarket notification and conformity assessment for devices. Routes of the same type appear side by side on the comparison pages.
No. Time targets come from laws, regulations and published performance goals. Actual review times are shown separately, only for markets whose official approvals data gives both the start date and the decision date.
Each pathway shows the date it was last checked against the official rules; the most recent check was on October 3, 2026. Official guidance and law pages are monitored for changes, and changed pages are reviewed again.
Every local route is mapped to one of these types
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.