feat(regulatory): 对齐附件4目录核查规则
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@@ -11,3 +11,15 @@ def test_structure_check_reports_missing_instruction_sections():
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assert any(finding.rule_code == "instructions_for_use:储存条件" for finding in findings)
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assert all("样本要求" not in finding.title for finding in findings)
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def test_structure_check_reports_missing_attachment4_outline_heading():
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document_texts = {
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"申报资料目录.txt": "1. 监管信息\n1.2 申请表\n2. 综述资料\n3. 非临床资料\n"
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}
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findings = run_structure_check(document_texts, load_rule_file())
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missing = next(finding for finding in findings if finding.rule_code == "attachment4_4_clinical_evaluation")
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assert missing.category == "structure"
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assert missing.evidence["expected_title"] == "临床评价资料"
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