release: v1.8.2 ICH M15 citation alignment

docs/regulatory_basis_registry.v1.json

@@ -3,7 +3,7 @@
   "as_of": "May 2026",
   "display_note": {
     "title": "Regulatory basis note",
-    "body_line_1": "Aligned to current official source classes as of May 2026: EU AI Act (Regulation (EU) 2024/1689), FDA QMSR, FDA AI-enabled device guidance themes, and IMDRF SaMD/GMLP frameworks.",
+    "body_line_1": "Aligned to current official source classes as of June 2026: EU AI Act (Regulation (EU) 2024/1689), FDA QMSR, FDA AI-enabled device guidance themes, IMDRF SaMD/GMLP frameworks, and ICH M15 General Principles for Model-Informed Drug Development.",
     "body_line_2": "This is a traceability aid, not a compliance or clearance determination."
   },
   "sources": [
@@ -83,6 +83,32 @@
       "url": "https://www.imdrf.org/documents/good-machine-learning-practice-medical-device-development-guiding-principles",
       "used_for": ["gmlp", "lifecycle_discipline", "human_ai_team", "risk_management"],
       "notes": "Use for lifecycle-discipline and transparency-adjacent references."
+    },
+    {
+      "id": "ich_m15_midd_2026",
+      "jurisdiction": "ICH",
+      "title": "ICH M15 General Principles for Model-Informed Drug Development",
+      "status": "final_guideline",
+      "published_date": "2026-01-01",
+      "effective_date": null,
+      "url": "https://www.ich.org/page/multidisciplinary-guidelines",
+      "used_for": [
+        "midd_context_of_use",
+        "model_verification",
+        "model_validation_applicability",
+        "model_analysis_plan",
+        "model_analysis_report",
+        "code_data_submission",
+        "regulatory_framework_signal"
+      ],
+      "sections": {
+        "2.1.2": "Context of Use — role and scope of model must be explicitly described",
+        "3": "Model Evaluation — Verification, Validation, and Applicability Assessment",
+        "4.1": "Model Analysis Plan (MAP) — pre-defined documentation of intended analysis",
+        "4.2": "Model Analysis Report (MAR) — results, evaluation, and technical criteria",
+        "4.3": "Documentation for Regulatory Submissions — code, data, and scripts must be available for review"
+      },
+      "notes": "Post-hoc alignment: STEM BIO-AI rubric items were designed before M15 adoption. Alignment is confirmed but not causally derived from M15. Cite as supporting regulatory context, not as compliance determination."
     }
   ]
 }