Variation Compass
One post-approval change: SFDA (v6.3) and EU (Guidelines C/2025/5045) classifications from the regulators' own tables, and the US reporting category under 21 CFR 314.70 — with the clause behind each category.
Open91 items
SFDA · EU · US FDA · WHO
Regulatory knowledge, side by side.
What regulators actually require — quoted in their own words, compared across jurisdictions, with the official source one click away. A free reference for regulatory affairs and pharmacovigilance professionals working with medicines in Saudi Arabia, the GCC, the EU and the US.
- Authorities compared
- 4
- Authorities monitored
- 6
- Word-for-word excerpts
- 275
- SFDA variation items compared
- 91
Regulatory affairs
What each authority requires for a post-approval change, a stability programme or a bioequivalence study — and what has changed.
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
Regulatory radar
New and revised documents from each authority's own index, and an alert when a document quoted here changes or disappears.
Pharmacovigilance
Safety signals by active substance, local literature screening and the Saudi-Specific Annex to the risk management plan.
Safety signals
Search an active substance: every EMA PRAC signal, US FDA safety-related labeling change and MHRA Drug Safety Update article on it, in the regulator's own words — with EMA's new SmPC and leaflet wording.
Open5,814 entries
Local literature
New articles in 35 Saudi and Gulf medical and pharmacy journals, searchable by active substance — case reports and NLM adverse-effects indexing flagged.
Open5,444 articles
Saudi-Specific Annex (SSA)
When SFDA requires the Saudi-Specific Annex to a risk management plan, what goes in each section, and which RMP parts an initial application needs — in SFDA's words, with a Word template.
OpenRMP annex 9
What you get
The regulator's own words
Comparison cells quote the regulator's sentence with its section number — not a summary.
The source, one click away
Every page links the official documents, so you can check the full text before you act.
What is changing
Drafts, superseded parts and documents a regulator has withdrawn are flagged where they matter.