Variation Compass
Post-approval changes: the SFDA and EU classifications from their own tables (IA / IAIN / IB / II), and the US category under 21 CFR 314.70 and FDA guidance (AR / CBE-0 / CBE-30 / PAS).
Open91 items
Compare · in the regulators' own words
Compare regulators
One topic at a time: what SFDA, the EU, the US FDA and WHO actually say — quoted word for word, section by section, side by side.
Bioequivalence & biowaivers
What each regulator requires to prove a generic is bioequivalent — design, subjects, acceptance limits, narrow-therapeutic-index and highly variable drugs, additional-strength and BCS biowaivers — in its own words, side by side.
Open153 excerpts
Stability testing & climatic zones
What each regulator requires for stability data — storage conditions, batches, months, shelf-life extrapolation and label statements — in its own words, side by side.
Open122 excerpts