Variation Compass
How SFDA, the EU, the UK and the US FDA classify the same post-approval change, with the governing clause.
Open91 items
SFDA · EU · MHRA · US FDA · Health Canada · WHO
Regulatory requirements and registered medicines
Requirements quoted verbatim with section references, product registers and safety signals, each linked to the official source. For regulatory affairs and pharmacovigilance.
- Authorities compared
- 4
- Authorities monitored
- 6
- Verbatim excerpts
- 284
- SFDA variation items mapped
- 91
- Registered products
- 101,794
- Active substances and combinations
- 5,636
New approvals and listings
Week of 26 Oct 2026 · US FDA, EMA, Health Canada, MHRA and SFDA registers.
- US FDA TRANEXAMIC ACID ANDA tranexamic acid · ZYDUS LIFESCIENCES · 27 Oct 2026
- US FDA RIVAROXABAN ANDA rivaroxaban · TEVA PHARMS USA · 27 Oct 2026
- US FDA VALGANCICLOVIR HYDROCHLORIDE ANDA valganciclovir hydrochloride · ALEMBIC · 26 Oct 2026
- US FDA PROPRANOLOL HYDROCHLORIDE ANDA propranolol hydrochloride · SENORES PHARMS · 26 Oct 2026
- US FDA EPINEPHRINE ANDA epinephrine · GLAND · 26 Oct 2026
Regulatory affairs
Post-approval changes, stability, bioequivalence, document changes and product registers.
Bioequivalence & biowaivers
Study design, acceptance limits, narrow therapeutic index and highly variable drugs, biowaivers.
Open162 excerpts
Stability testing & climatic zones
Storage conditions, batches, shelf life, extrapolation and labelling statements.
Open122 excerpts
Regulatory radar
New, revised and withdrawn documents from each authority's index; changes to the documents quoted in the comparisons.
Registered medicines
Products listed by SFDA, US FDA, EMA and Health Canada per active substance, with SFDA, NADAC and NHS Drug Tariff prices, authorised indications and WHO EML status.
Pharmacovigilance
Safety signals and local literature.
Safety signals
PRAC signal assessments, US FDA safety-related labeling changes and MHRA Drug Safety Update articles by active substance, with the PRAC-recommended SmPC and PL wording.
Open5,864 entries
Local literature
Articles in 35 Saudi and Gulf journals by active substance, for local literature screening; case reports and NLM adverse-effect indexing marked.
Open5,488 articles
Conventions
Verbatim text
Excerpts are quoted as published, with the section number; they are not paraphrased.
Official source
Each excerpt links to the authority's document; the official text prevails.
Status
Drafts, superseded provisions and withdrawn documents are marked.
Updated