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Radar · SFDA · EMA · US FDA · MHRA · ICH · WHO

Regulatory radar

What changed — taken from each authority's own index and files, not from news coverage. Updated 10 Oct 2026 · showing items from 10 Jul 2026.

6alerts
68EMA
20US FDA
6ICH
34MHRA
8SFDA
1WHO
27 of 28quoted documents still online
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Alerts

Week of 5 Oct 2026 26

Week of 28 Sep 2026 10

Week of 21 Sep 2026 7

Week of 14 Sep 2026 13

Week of 7 Sep 2026 9

Week of 31 Aug 2026 15

Week of 24 Aug 2026 2

Week of 17 Aug 2026 8

Week of 10 Aug 2026 6

Week of 3 Aug 2026 2

Week of 27 Jul 2026 12

Week of 20 Jul 2026 3

Week of 13 Jul 2026 27

Week of 6 Jul 2026 1

Documents quoted on this site

Every document behind the Variation Compass and the comparison pages is checked for changes at each update.

DocumentStatusUsed on
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
Stability conditions for WHO Member States by Region ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
ICH M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
ICH M9 Biopharmaceutics Classification System-based Biowaivers ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
ICH Q1A(R2) Stability Testing of New Drug Substances and Products ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
ICH Q1E Evaluation of Stability Data ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
EU Variations Guidelines C/2025/5045 Online (10 Oct 2026) Variation Compass
21 CFR 314.70 — Supplements and other changes to an approved NDA ✓ Unchanged (10 Oct 2026) Variation Compass
21 CFR Part 320 — Bioavailability and Bioequivalence Requirements ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms Online (10 Oct 2026) Bioequivalence & biowaivers
EMA Guideline on the investigation of bioequivalence Online (10 Oct 2026) Bioequivalence & biowaivers
Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products Online (10 Oct 2026) Stability testing & climatic zones
Guideline on Declaration of Storage Conditions: A: in the Product Information of Medicinal Products, B: for Active Substances Online (10 Oct 2026) Stability testing & climatic zones
M9 Biopharmaceutics Classification System-Based Biowaivers — Guidance for Industry ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
Statistical Approaches to Establishing Bioequivalence — Guidance for Industry ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms — Guidance for Industry ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA — Guidance for Industry ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
Q1A(R2) Stability Testing of New Drug Substances and Products ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
Q1E Evaluation of Stability Data ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
FDA — Changes to an Approved NDA or ANDA (Rev. 1, 2004) ✓ Unchanged (10 Oct 2026) Variation Compass
FDA — CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (2014) ✓ Unchanged (10 Oct 2026) Variation Compass
ANDAs: Stability Testing of Drug Substances and Products ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
ANDAs: Stability Testing of Drug Substances and Products — Questions and Answers ✓ Unchanged (10 Oct 2026) Stability testing & climatic zones
The GCC Guidelines for Stability Testing of Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs) No longer online Stability testing & climatic zones
SFDA Guidelines for Bioequivalence (v3.1) ✓ Unchanged (10 Oct 2026) Bioequivalence & biowaivers
SFDA Guidelines for Variation Requirements v6.3 (DS-G-006) ✓ Unchanged (10 Oct 2026) Variation Compass
SFDA Guideline on Good Pharmacovigilance Practices (GVP) v4.0 (DS-G-008) Online (10 Oct 2026) Saudi-Specific Annex (SSA)

The radar reads each regulator's public index: SFDA drug-sector listings (Arabic and English), EMA's daily document export (guidelines, templates, safety communications), the US FDA guidance index for CDER/CBER, GOV.UK for the MHRA, ICH news and press releases, and WHO publications on pharmaceutical norms and standards. Dates are the regulator's own. Some SFDA listings are incomplete while SFDA moves its website, so an item missing from SFDA is never reported as removed. Medicines only: MHRA medical-device items and EMA veterinary items are not listed.