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feat(regulatory): 对齐附件4目录核查规则

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bruce
2026-06-07 09:27:42 +08:00
parent bbd2d3532a
commit 1bdc7322cf
15 changed files with 753 additions and 43 deletions
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515
review_agent/regulatory_review/rules/nmpa_ivd_registration_v1.yaml
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@@ -1,58 +1,503 @@
code: nmpa_ivd_registration_v1
name: NMPA IVD 注册资料 Demo 规则
name: NMPA IVD 注册资料附件 4 对齐规则
rag_collection: nmpa_ivd_registration_v1
source_material_dir: docs/0.原始材料/关于公布体外诊断试剂注册申报资料要求和批准证明文件格式的公告
source_material_dir: docs/0.原始材料
attachment4_required_codes:
- "1"
- "1.1"
- "1.2"
- "1.3"
- "1.4"
- "1.5"
- "1.6"
- "1.7"
- "2"
- "2.1"
- "2.2"
- "2.3"
- "2.4"
- "2.5"
- "2.6"
- "3"
- "3.1"
- "3.2"
- "3.3"
- "3.4"
- "3.5"
- "3.6"
- "3.7"
- "3.8"
- "4"
- "4.1"
- "4.2"
- "5"
- "5.1"
- "5.2"
- "5.3"
- "5.4"
- "6"
- "6.1"
- "6.2"
- "6.3"
- "6.4"
- "6.5"
- "6.6"
- "6.7"
- "6.8"
- "6.9"
- "6.10"
requirements:
- code: product_technical_requirements
title: 产品技术要求
- code: attachment4_1_regulatory_info
rule_id: A4-1
attachment4_code: "1"
title: 监管信息
type: chapter
severity: high
category: completeness
file_keywords: [监管信息]
aliases: [监管资料]
suggestion: 请补充监管信息章节及其目录项。
citation_query: 附件4 监管信息 体外诊断试剂 注册申报资料
structure_required: true
- code: attachment4_1_1_toc
rule_id: A4-1.1
attachment4_code: "1.1"
title: 章节目录
type: directory
severity: medium
category: completeness
file_keywords: [章节目录, 目录]
aliases: [监管信息目录]
suggestion: 请补充监管信息章节目录。
citation_query: 附件4 监管信息 章节目录
- code: attachment4_1_2_application_form
rule_id: A4-1.2
attachment4_code: "1.2"
title: 申请表
type: required
severity: blocking
category: completeness
file_keywords:
- 产品技术要求
suggestion: 请补充产品技术要求并确认版本与注册申请资料一致。
citation_query: 体外诊断试剂 产品技术要求 注册申报资料
- code: instructions_for_use
title: 说明书
file_keywords: [申请表, 注册申请表]
aliases: [医疗器械注册申请表]
suggestion: 请补充注册申请表并核对注册类型、管理类别和分类编码。
citation_query: 附件4 监管信息 申请表
- code: attachment4_1_3_terms
rule_id: A4-1.3
attachment4_code: "1.3"
title: 术语/缩写词列表
type: recommended
severity: medium
category: completeness
file_keywords: [术语, 缩写词, 缩略语]
suggestion: 请补充术语和缩写词列表。
citation_query: 附件4 术语 缩写词列表
- code: attachment4_1_4_product_list
rule_id: A4-1.4
attachment4_code: "1.4"
title: 产品列表
type: required
severity: high
category: completeness
file_keywords:
- 说明书
- 使用说明
required_sections:
- 储存条件
- 有效期
- 样本要求
suggestion: 请补充说明书并核对储存条件、有效期和样本要求章节。
citation_query: 体外诊断试剂 说明书 储存条件 有效期 样本要求
file_keywords: [产品列表, 产品清单]
suggestion: 请补充申报产品列表。
citation_query: 附件4 产品列表
- code: attachment4_1_5_related_files
rule_id: A4-1.5
attachment4_code: "1.5"
title: 关联文件
type: conditional
severity: medium
category: completeness
file_keywords: [关联文件, 关联注册, 引用文件]
suggestion: 如存在关联注册或引用资料，请补充关联文件说明。
citation_query: 附件4 关联文件
- code: attachment4_1_6_pre_submission
rule_id: A4-1.6
attachment4_code: "1.6"
title: 申报前与监管机构的联系情况和沟通记录
type: conditional
severity: medium
category: completeness
file_keywords: [沟通记录, 监管机构, 申报前]
suggestion: 如有申报前沟通，请补充沟通记录；如无，请说明不适用。
citation_query: 附件4 申报前 监管机构 沟通记录
- code: attachment4_1_7_declaration
rule_id: A4-1.7
attachment4_code: "1.7"
title: 符合性声明
type: required
severity: blocking
category: completeness
file_keywords: [符合性声明, 声明]
suggestion: 请补充符合性声明。
citation_query: 附件4 符合性声明
- code: attachment4_2_summary
rule_id: A4-2
attachment4_code: "2"
title: 综述资料
type: chapter
severity: high
category: completeness
file_keywords: [综述资料]
suggestion: 请补充综述资料章节。
citation_query: 附件4 综述资料
structure_required: true
- code: attachment4_2_1_toc
rule_id: A4-2.1
attachment4_code: "2.1"
title: 章节目录
type: directory
severity: medium
category: completeness
file_keywords: [章节目录, 综述资料目录]
suggestion: 请补充综述资料章节目录。
citation_query: 附件4 综述资料 章节目录
- code: attachment4_2_2_overview
rule_id: A4-2.2
attachment4_code: "2.2"
title: 概述
type: required
severity: high
category: completeness
file_keywords: [概述]
suggestion: 请补充产品概述。
citation_query: 附件4 概述
- code: attachment4_2_3_product_description
rule_id: A4-2.3
attachment4_code: "2.3"
title: 产品描述
type: required
severity: high
category: completeness
file_keywords: [产品描述]
suggestion: 请补充产品描述。
citation_query: 附件4 产品描述
- code: attachment4_2_4_intended_use
rule_id: A4-2.4
attachment4_code: "2.4"
title: 预期用途
type: required
severity: high
category: completeness
file_keywords: [预期用途]
suggestion: 请补充预期用途资料。
citation_query: 附件4 预期用途
- code: attachment4_2_5_marketing_history
rule_id: A4-2.5
attachment4_code: "2.5"
title: 申报产品上市历史
type: conditional
severity: medium
category: completeness
file_keywords: [上市历史]
suggestion: 如产品已有上市历史，请补充相关说明；如无，请说明不适用。
citation_query: 附件4 上市历史
- code: attachment4_2_6_other_summary
rule_id: A4-2.6
attachment4_code: "2.6"
title: 其他需说明的内容
type: conditional
severity: medium
category: completeness
file_keywords: [其他需说明, 其他说明]
suggestion: 请补充其他需说明内容或不适用说明。
citation_query: 附件4 其他需说明
- code: attachment4_3_nonclinical
rule_id: A4-3
attachment4_code: "3"
title: 非临床资料
type: chapter
severity: high
category: completeness
file_keywords: [非临床资料]
suggestion: 请补充非临床资料章节。
citation_query: 附件4 非临床资料
structure_required: true
- code: attachment4_3_1_toc
rule_id: A4-3.1
attachment4_code: "3.1"
title: 章节目录
type: directory
severity: medium
category: completeness
file_keywords: [章节目录, 非临床资料目录]
suggestion: 请补充非临床资料章节目录。
citation_query: 附件4 非临床资料 章节目录
- code: attachment4_3_2_risk_management
rule_id: A4-3.2
attachment4_code: "3.2"
title: 产品风险管理资料
type: required
severity: high
category: completeness
file_keywords: [产品风险管理, 风险管理资料]
suggestion: 请补充产品风险管理资料。
citation_query: 附件4 产品风险管理资料
- code: essential_principles_checklist
rule_id: A4-3.3
attachment4_code: "3.3"
title: 体外诊断试剂安全和性能基本原则清单
type: recommended
severity: medium
category: completeness
file_keywords: [安全和性能基本原则, 基本原则清单]
aliases: [安全和性能基本原则清单]
suggestion: 建议补充安全和性能基本原则清单，便于审评追溯。
citation_query: 附件4 安全和性能基本原则清单
- code: product_technical_requirements
rule_id: A4-3.4
attachment4_code: "3.4"
title: 产品技术要求及检验报告
type: required
severity: blocking
category: completeness
file_keywords: [产品技术要求, 注册检验报告, 检验报告]
aliases: [产品技术要求, 注册检验报告]
required_sections: [产品技术要求, 检验报告]
suggestion: 请补充产品技术要求及注册检验报告，并确认二者覆盖型号一致。
citation_query: 附件4 产品技术要求 检验报告
- code: registration_test_report
rule_id: A4-3.4-R
attachment4_code: "3.4"
title: 注册检验报告
type: required
severity: blocking
category: completeness
file_keywords:
- 注册检验报告
- 检验报告
file_keywords: [注册检验报告, 检验报告]
suggestion: 请补充注册检验报告并复核报告覆盖的产品型号。
citation_query: 体外诊断试剂 注册检验报告 注册申报资料
citation_query: 附件4 注册检验报告
- code: attachment4_3_5_analytical_performance
rule_id: A4-3.5
attachment4_code: "3.5"
title: 分析性能研究
type: required
severity: high
category: completeness
file_keywords: [分析性能研究, 分析性能]
suggestion: 请补充分析性能研究资料。
citation_query: 附件4 分析性能研究
- code: attachment4_3_6_stability
rule_id: A4-3.6
attachment4_code: "3.6"
title: 稳定性研究
type: required
severity: high
category: completeness
file_keywords: [稳定性研究, 稳定性]
suggestion: 请补充稳定性研究资料。
citation_query: 附件4 稳定性研究
- code: attachment4_3_7_reference_interval
rule_id: A4-3.7
attachment4_code: "3.7"
title: 阳性判断值或参考区间研究
type: required
severity: high
category: completeness
file_keywords: [阳性判断值, 参考区间]
suggestion: 请补充阳性判断值或参考区间研究资料。
citation_query: 附件4 阳性判断值 参考区间
- code: attachment4_3_8_other_nonclinical
rule_id: A4-3.8
attachment4_code: "3.8"
title: 其他资料
type: conditional
severity: medium
category: completeness
file_keywords: [其他资料]
suggestion: 请补充非临床其他资料或不适用说明。
citation_query: 附件4 非临床 其他资料
- code: attachment4_4_clinical_evaluation
rule_id: A4-4
attachment4_code: "4"
title: 临床评价资料
type: chapter
severity: high
category: completeness
file_keywords: [临床评价资料, 临床资料]
suggestion: 请补充临床评价资料章节。
citation_query: 附件4 临床评价资料
structure_required: true
- code: attachment4_4_1_toc
rule_id: A4-4.1
attachment4_code: "4.1"
title: 章节目录
type: directory
severity: medium
category: completeness
file_keywords: [章节目录, 临床评价资料目录]
suggestion: 请补充临床评价资料章节目录。
citation_query: 附件4 临床评价资料 章节目录
- code: clinical_evaluation
rule_id: A4-4.2
attachment4_code: "4.2"
title: 临床评价资料
type: conditional
severity: high
category: completeness
file_keywords:
- 临床评价
- 临床试验
file_keywords: [临床评价, 临床试验, 免临床, 同品种比对]
suggestion: 请根据适用情形补充临床评价资料或说明豁免依据。
citation_query: 体外诊断试剂 临床评价资料 注册申报
- code: essential_principles_checklist
title: 安全和性能基本原则清单
type: recommended
citation_query: 附件4 临床评价资料 注册申报
- code: attachment4_5_ifu_label
rule_id: A4-5
attachment4_code: "5"
title: 产品说明书和标签样稿
type: chapter
severity: high
category: completeness
file_keywords: [产品说明书和标签样稿, 说明书, 标签样稿]
suggestion: 请补充产品说明书和标签样稿章节。
citation_query: 附件4 产品说明书 标签样稿
structure_required: true
- code: attachment4_5_1_toc
rule_id: A4-5.1
attachment4_code: "5.1"
title: 章节目录
type: directory
severity: medium
category: completeness
file_keywords:
- 安全和性能基本原则
- 基本原则清单
suggestion: 建议补充安全和性能基本原则清单，便于审评追溯。
citation_query: 体外诊断试剂 安全和性能基本原则清单
file_keywords: [章节目录, 说明书目录, 标签目录]
suggestion: 请补充产品说明书和标签样稿章节目录。
citation_query: 附件4 说明书 标签 章节目录
- code: instructions_for_use
rule_id: A4-5.2
attachment4_code: "5.2"
title: 产品说明书
type: required
severity: high
category: completeness
file_keywords: [说明书, 产品说明书, 使用说明]
aliases: [说明书]
required_sections: [储存条件, 有效期, 样本要求]
suggestion: 请补充说明书并核对储存条件、有效期和样本要求章节。
citation_query: 附件4 产品说明书 储存条件 有效期 样本要求
- code: attachment4_5_3_label
rule_id: A4-5.3
attachment4_code: "5.3"
title: 标签样稿
type: required
severity: high
category: completeness
file_keywords: [标签样稿, 标签]
suggestion: 请补充标签样稿。
citation_query: 附件4 标签样稿
- code: attachment4_5_4_other_ifu
rule_id: A4-5.4
attachment4_code: "5.4"
title: 其他资料
type: conditional
severity: medium
category: completeness
file_keywords: [其他资料]
suggestion: 请补充说明书和标签相关其他资料或不适用说明。
citation_query: 附件4 说明书 标签 其他资料
- code: attachment4_6_quality_system
rule_id: A4-6
attachment4_code: "6"
title: 质量管理体系文件
type: chapter
severity: high
category: completeness
file_keywords: [质量管理体系文件, 质量体系, 质量管理体系]
suggestion: 请补充质量管理体系文件章节。
citation_query: 附件4 质量管理体系文件
structure_required: true
- code: attachment4_6_1_overview
rule_id: A4-6.1
attachment4_code: "6.1"
title: 综述
type: required
severity: high
category: completeness
file_keywords: [综述]
suggestion: 请补充质量管理体系综述。
citation_query: 附件4 质量管理体系 综述
- code: attachment4_6_2_toc
rule_id: A4-6.2
attachment4_code: "6.2"
title: 章节目录
type: directory
severity: medium
category: completeness
file_keywords: [章节目录, 质量管理体系目录]
suggestion: 请补充质量管理体系文件章节目录。
citation_query: 附件4 质量管理体系 章节目录
- code: attachment4_6_3_manufacturing
rule_id: A4-6.3
attachment4_code: "6.3"
title: 生产制造信息
type: required
severity: high
category: completeness
file_keywords: [生产制造信息, 生产制造]
suggestion: 请补充生产制造信息。
citation_query: 附件4 生产制造信息
- code: attachment4_6_4_qms_procedure
rule_id: A4-6.4
attachment4_code: "6.4"
title: 质量管理体系程序
type: required
severity: high
category: completeness
file_keywords: [质量管理体系程序, 质量体系程序]
suggestion: 请补充质量管理体系程序。
citation_query: 附件4 质量管理体系程序
- code: attachment4_6_5_management
rule_id: A4-6.5
attachment4_code: "6.5"
title: 管理职责程序
type: required
severity: high
category: completeness
file_keywords: [管理职责程序, 管理职责]
suggestion: 请补充管理职责程序。
citation_query: 附件4 管理职责程序
- code: attachment4_6_6_resource
rule_id: A4-6.6
attachment4_code: "6.6"
title: 资源管理程序
type: required
severity: high
category: completeness
file_keywords: [资源管理程序, 资源管理]
suggestion: 请补充资源管理程序。
citation_query: 附件4 资源管理程序
- code: attachment4_6_7_realization
rule_id: A4-6.7
attachment4_code: "6.7"
title: 产品实现程序
type: required
severity: high
category: completeness
file_keywords: [产品实现程序, 产品实现]
suggestion: 请补充产品实现程序。
citation_query: 附件4 产品实现程序
- code: attachment4_6_8_measurement
rule_id: A4-6.8
attachment4_code: "6.8"
title: 质量管理体系的测量/分析和改进程序
type: required
severity: high
category: completeness
file_keywords: [测量, 分析和改进, 改进程序]
suggestion: 请补充质量管理体系测量、分析和改进程序。
citation_query: 附件4 测量 分析 改进程序
- code: attachment4_6_9_other_qms
rule_id: A4-6.9
attachment4_code: "6.9"
title: 其他质量体系程序信息
type: conditional
severity: medium
category: completeness
file_keywords: [其他质量体系程序, 其他质量体系]
suggestion: 请补充其他质量体系程序信息或不适用说明。
citation_query: 附件4 其他质量体系程序信息
- code: attachment4_6_10_qms_audit
rule_id: A4-6.10
attachment4_code: "6.10"
title: 质量管理体系核查文件
type: required
severity: high
category: completeness
file_keywords: [质量管理体系核查文件, 体系核查文件, 核查文件]
suggestion: 请补充质量管理体系核查文件。
citation_query: 附件4 质量管理体系核查文件

14
review_agent/regulatory_review/services/completeness_check.py
View File

@@ -8,12 +8,17 @@ def run_completeness_check(batch: FileSummaryBatch, rule_set: dict) -> list[Find
items = list(batch.items.order_by("file_index"))
findings: list[Finding] = []
for requirement in rule_set.get("requirements", []):
if requirement.get("type") not in {"required", "conditional", "recommended"}:
if requirement.get("type") not in {"required", "conditional", "recommended", "chapter", "directory"}:
continue
matched = [
item
for item in items
if _matches_item(item.file_name, item.relative_path, requirement.get("file_keywords", []))
if _matches_item(
item.file_name,
item.relative_path,
item.directory_level,
[*requirement.get("file_keywords", []), *requirement.get("aliases", [])],
)
]
if matched:
continue
@@ -29,12 +34,13 @@ def run_completeness_check(batch: FileSummaryBatch, rule_set: dict) -> list[Find
"requirement_type": requirement.get("type"),
"matched_files": [],
"searched_keywords": requirement.get("file_keywords", []),
"searched_fields": ["file_name", "relative_path", "directory_level"],
},
)
)
return findings
def _matches_item(file_name: str, relative_path: str, keywords: list[str]) -> bool:
haystack = f"{file_name} {relative_path}".lower()
def _matches_item(file_name: str, relative_path: str, directory_level: str, keywords: list[str]) -> bool:
haystack = f"{file_name} {relative_path} {directory_level}".lower()
return any(str(keyword).lower() in haystack for keyword in keywords)

4
review_agent/regulatory_review/services/consistency_check.py
View File

@@ -10,6 +10,10 @@ FIELDS = {
"产品名称": r"产品名称[:：]\s*([^\n\r]+)",
"型号规格": r"型号规格[:：]\s*([^\n\r]+)",
"预期用途": r"预期用途[:：]\s*([^\n\r]+)",
"管理类别": r"管理类别[:：]\s*([^\n\r]+)",
"分类编码": r"分类编码[:：]\s*([^\n\r]+)",
"注册类型": r"注册类型[:：]\s*([^\n\r]+)",
"临床评价路径": r"临床评价路径[:：]\s*([^\n\r]+)",
}

7
review_agent/regulatory_review/services/rag_index.py
View File

@@ -107,12 +107,19 @@ def collect_source_chunks(source_dir: Path) -> list[TextChunk]:
try:
text = extract_text_from_path(path)
except RuntimeError as exc:
if _is_attachment4(path):
raise RuntimeError(f"附件 4 核心法规材料抽取失败：{path.name}") from exc
logger.warning("Regulatory source extraction skipped", extra={"path": str(path), "error": str(exc)})
continue
chunks.extend(chunk_text(text, source=str(path.relative_to(source_dir))))
return chunks
def _is_attachment4(path: Path) -> bool:
normalized = path.name.replace(" ", "")
return "附件4" in normalized and "体外诊断试剂注册申报资料要求及说明" in normalized
def build_chroma_index(
*,
source_dir: Path,

21
review_agent/regulatory_review/services/rule_loader.py
View File

@@ -47,9 +47,30 @@ def load_rule_file(path: str | Path | None = None) -> dict:
raise ValueError(f"规则 code 必须为 {DEFAULT_RULE_CODE}")
if not isinstance(payload.get("requirements"), list) or not payload["requirements"]:
raise ValueError("规则文件必须包含 requirements 列表。")
_validate_attachment4_requirements(payload)
return payload
def _validate_attachment4_requirements(payload: dict) -> None:
requirements = payload.get("requirements") or []
required_codes = {str(code) for code in payload.get("attachment4_required_codes") or []}
by_attachment4_code: dict[str, list[dict]] = {}
for requirement in requirements:
attachment4_code = requirement.get("attachment4_code")
if attachment4_code:
by_attachment4_code.setdefault(str(attachment4_code), []).append(requirement)
for field in ["code", "rule_id", "title", "severity", "file_keywords", "citation_query"]:
if attachment4_code and not requirement.get(field):
raise ValueError(f"附件4规则 {attachment4_code} 缺少 {field}")
missing = sorted(required_codes - set(by_attachment4_code), key=_attachment4_sort_key)
if missing:
raise ValueError(f"附件4目录项缺少规则：{', '.join(missing)}")
def _attachment4_sort_key(value: str) -> tuple[int, ...]:
return tuple(int(part) for part in value.split(".") if part.isdigit())
def check_rule_version(
*,
path: str | Path | None = None,

31
review_agent/regulatory_review/services/structure_check.py
View File

@@ -5,7 +5,27 @@ from review_agent.regulatory_review.schemas import Finding
def run_structure_check(document_texts: dict[str, str], rule_set: dict) -> list[Finding]:
findings: list[Finding] = []
combined_all_text = "\n".join(document_texts.values())
for requirement in rule_set.get("requirements", []):
if requirement.get("structure_required") and not _contains_any(
combined_all_text,
[requirement.get("title", ""), *requirement.get("aliases", [])],
):
findings.append(
Finding(
rule_code=requirement["code"],
category="structure",
severity=requirement.get("severity", "medium"),
title=f"申报资料目录缺少{requirement['title']}章节",
detail=f"未在申报资料目录或章节标题候选中发现{requirement['title']}。",
suggestion=requirement.get("suggestion", ""),
evidence={
"attachment4_code": requirement.get("attachment4_code"),
"expected_title": requirement["title"],
"aliases": requirement.get("aliases", []),
},
)
)
required_sections = requirement.get("required_sections") or []
if not required_sections:
continue
@@ -14,7 +34,7 @@ def run_structure_check(document_texts: dict[str, str], rule_set: dict) -> list[
continue
combined_text = "\n".join(matching_docs.values())
for section in required_sections:
if section in combined_text:
if _contains_any(combined_text, [section]):
continue
findings.append(
Finding(
@@ -39,3 +59,12 @@ def _matching_documents(document_texts: dict[str, str], keywords: list[str]) ->
if any(str(keyword).lower() in haystack for keyword in keywords):
result[name] = text
return result
def _contains_any(text: str, needles: list[str]) -> bool:
normalized = _normalize_title(text)
return any(_normalize_title(needle) in normalized for needle in needles if needle)
def _normalize_title(value: str) -> str:
return "".join(str(value).lower().replace("/", "").replace("／", "").split())

49
review_agent/regulatory_review/services/text_extract.py
View File

@@ -1,6 +1,7 @@
from __future__ import annotations
import hashlib
import re
from dataclasses import dataclass
from pathlib import Path
@@ -14,6 +15,9 @@ class ExtractedText:
status: str
content_hash: str = ""
error_message: str = ""
front_text: str = ""
section_candidates: list[str] | None = None
field_candidates: dict[str, str] | None = None
SUPPORTED_EXTENSIONS = {".txt", ".md", ".pdf", ".docx", ".pptx", ".xlsx", ".doc"}
@@ -26,6 +30,47 @@ def extract_text(path: str | Path) -> ExtractedText:
try:
text = extract_text_from_path(file_path)
except Exception as exc:
return ExtractedText(path=file_path, text="", status="failed", error_message=str(exc))
return ExtractedText(
path=file_path,
text="",
status="failed",
error_message=str(exc),
section_candidates=[],
field_candidates={},
)
content_hash = hashlib.sha256(text.encode("utf-8")).hexdigest() if text else ""
return ExtractedText(path=file_path, text=text, status="success", content_hash=content_hash)
return ExtractedText(
path=file_path,
text=text,
status="success",
content_hash=content_hash,
front_text=_front_text(text),
section_candidates=_section_candidates(text),
field_candidates=_field_candidates(text),
)
def _front_text(text: str, limit: int = 1200) -> str:
return text[:limit]
def _section_candidates(text: str) -> list[str]:
candidates = []
for line in text.splitlines():
normalized = line.strip()
if not normalized:
continue
if re.match(r"^([一二三四五六七八九十]+[、.．]|[0-9]+(\.[0-9]+)*[、.．\s])", normalized):
candidates.append(normalized[:120])
elif any(keyword in normalized for keyword in ["章节目录", "监管信息", "综述资料", "非临床资料", "临床评价资料", "质量管理体系"]):
candidates.append(normalized[:120])
return candidates[:80]
def _field_candidates(text: str) -> dict[str, str]:
fields = {}
for label in ["产品名称", "型号规格", "预期用途", "管理类别", "分类编码", "注册类型", "临床评价路径"]:
match = re.search(rf"{label}[:：]\s*([^\n\r]+)", text)
if match:
fields[label] = " ".join(match.group(1).strip().split())
return fields

51
review_agent/regulatory_review/workflow.py
View File

@@ -1,5 +1,6 @@
from __future__ import annotations
import json
import logging
from pathlib import Path
from threading import Thread
@@ -26,6 +27,7 @@ from review_agent.regulatory_review.services.structure_check import run_structur
from review_agent.regulatory_review.services.text_extract import extract_text
from .events import record_event
from .storage import save_artifact
NODE_DEFINITIONS = [
@@ -105,6 +107,7 @@ class RegulatoryWorkflowExecutor:
self.rule_set: dict | None = None
self.findings = []
self.document_texts: dict[str, str] = {}
self.text_extract_status: dict[str, dict[str, object]] = {}
def run(self) -> None:
self.batch.status = RegulatoryReviewBatch.Status.RUNNING
@@ -176,6 +179,13 @@ class RegulatoryWorkflowExecutor:
return
if node_code == "text_extract":
self.document_texts = self._extract_source_texts()
save_artifact(
self.batch,
name="text_extract_status.json",
artifact_type="json",
content=json.dumps(self.text_extract_status, ensure_ascii=False, indent=2),
metadata={"artifact": "text_extract_status"},
)
return
if node_code == "structure_check":
self.findings.extend(run_structure_check(self.document_texts, self._rules()))
@@ -184,7 +194,29 @@ class RegulatoryWorkflowExecutor:
self.findings.extend(run_consistency_check(self.document_texts))
return
if node_code == "risk_assess":
persist_findings(self.batch, self.findings)
issues = persist_findings(self.batch, self.findings)
save_artifact(
self.batch,
name="rag_result_json.json",
artifact_type="json",
content=json.dumps(
{
"batch_no": self.batch.batch_no,
"text_extract_status": self.text_extract_status,
"issues": [
{
"rule_code": issue.rule_code,
"title": issue.title,
"citations": issue.citations,
}
for issue in issues
],
},
ensure_ascii=False,
indent=2,
),
metadata={"artifact": "rag_result_json"},
)
return
if node_code == "report_export":
exports = export_review_results(self.batch)
@@ -234,8 +266,25 @@ class RegulatoryWorkflowExecutor:
if not path.is_absolute():
path = Path(settings.MEDIA_ROOT) / item.storage_path
if not path.exists():
self.text_extract_status[item.file_name] = {
"status": "missing",
"path": str(path),
"content_hash": "",
"section_candidates": [],
"field_candidates": {},
"front_text": "",
}
continue
result = extract_text(path)
self.text_extract_status[item.file_name] = {
"status": result.status,
"path": str(path),
"content_hash": result.content_hash,
"section_candidates": result.section_candidates,
"field_candidates": result.field_candidates,
"front_text": result.front_text,
"error_message": result.error_message,
}
if result.status == "success" and result.text:
texts[item.file_name] = result.text
return texts

8
tests/fixtures/regulatory/attachment4_outline.json vendored Normal file
View File

@@ -0,0 +1,8 @@
[
{"code": "1", "title": "监管信息", "children": ["章节目录", "申请表", "术语/缩写词列表", "产品列表", "关联文件", "申报前与监管机构的联系情况和沟通记录", "符合性声明"]},
{"code": "2", "title": "综述资料", "children": ["章节目录", "概述", "产品描述", "预期用途", "申报产品上市历史", "其他需说明的内容"]},
{"code": "3", "title": "非临床资料", "children": ["章节目录", "产品风险管理资料", "体外诊断试剂安全和性能基本原则清单", "产品技术要求及检验报告", "分析性能研究", "稳定性研究", "阳性判断值或参考区间研究", "其他资料"]},
{"code": "4", "title": "临床评价资料", "children": ["章节目录", "临床评价资料"]},
{"code": "5", "title": "产品说明书和标签样稿", "children": ["章节目录", "产品说明书", "标签样稿", "其他资料"]},
{"code": "6", "title": "质量管理体系文件", "children": ["综述", "章节目录", "生产制造信息", "质量管理体系程序", "管理职责程序", "资源管理程序", "产品实现程序", "质量管理体系的测量/分析和改进程序", "其他质量体系程序信息", "质量管理体系核查文件"]}
]

27
tests/test_regulatory_completeness.py
View File

@@ -42,3 +42,30 @@ def test_completeness_check_matches_existing_files_and_reports_missing(django_us
missing = next(finding for finding in findings if finding.rule_code == "registration_test_report")
assert missing.severity == "blocking"
assert missing.category == "completeness"
def test_completeness_check_matches_attachment4_directory_names(django_user_model):
user = django_user_model.objects.create_user(username="owner", password="pass")
conversation = Conversation.objects.create(user=user, title="会话")
batch = FileSummaryBatch.objects.create(
conversation=conversation,
user=user,
batch_no="FS-A4",
status=FileSummaryBatch.Status.SUCCESS,
)
FileSummaryItem.objects.create(
batch=batch,
file_index=1,
directory_level="1. 监管信息 / 1.2 申请表",
file_name="注册申请表.pdf",
file_type="pdf",
relative_path="1.监管信息/1.2申请表/注册申请表.pdf",
storage_path="x/app.pdf",
)
findings = run_completeness_check(batch, load_rule_file())
assert not any(finding.rule_code == "attachment4_1_2_application_form" for finding in findings)
missing_qms = next(finding for finding in findings if finding.rule_code == "attachment4_6_quality_system")
assert missing_qms.severity == "high"
assert missing_qms.evidence["searched_fields"] == ["file_name", "relative_path", "directory_level"]

13
tests/test_regulatory_consistency.py
View File

@@ -12,3 +12,16 @@ def test_consistency_check_reports_product_name_mismatch():
assert len(findings) == 1
assert findings[0].category == "consistency"
assert "产品名称" in findings[0].title
def test_consistency_check_reports_registration_scope_fields():
document_texts = {
"申请表.docx": "管理类别：第二类\n分类编码：6840\n注册类型：首次注册\n临床评价路径：免临床",
"综述资料.docx": "管理类别：第三类\n分类编码：6840\n注册类型：首次注册\n临床评价路径：临床试验",
}
findings = run_consistency_check(document_texts)
titles = [finding.title for finding in findings]
assert "管理类别在不同文件中不一致" in titles
assert "临床评价路径在不同文件中不一致" in titles

16
tests/test_regulatory_rag.py
View File

@@ -6,6 +6,7 @@ from review_agent.regulatory_review.services.rag_citation import (
)
from review_agent.regulatory_review.services.rag_embedding import SiliconFlowEmbeddingProvider
from review_agent.regulatory_review.services.rag_index import chunk_text
from review_agent.regulatory_review.services.rag_index import collect_source_chunks
def test_siliconflow_embedding_provider_posts_expected_payload(monkeypatch):
@@ -70,3 +71,18 @@ def test_retrieve_citations_raises_when_index_missing(settings, tmp_path):
with pytest.raises(RagIndexUnavailable):
retrieve_citations("注册检验报告", embedding_provider=lambda texts: [[0.1]])
def test_collect_source_chunks_requires_attachment4_extraction(monkeypatch, tmp_path):
source_dir = tmp_path / "sources"
source_dir.mkdir()
attachment4 = source_dir / "附件 4 体外诊断试剂注册申报资料要求及说明.doc"
attachment4.write_bytes(b"legacy-doc")
def fail_extract(path):
raise RuntimeError("无法通过 LibreOffice 转换法规 .doc 材料")
monkeypatch.setattr("review_agent.regulatory_review.services.rag_index.extract_text_from_path", fail_extract)
with pytest.raises(RuntimeError, match="附件 4"):
collect_source_chunks(source_dir)

25
tests/test_regulatory_rule_loader.py
View File

@@ -1,4 +1,5 @@
from pathlib import Path
import json
import pytest
from django.core.management import call_command
@@ -27,6 +28,30 @@ def test_load_rule_file_reads_demo_requirements():
assert "essential_principles_checklist" in codes
def test_load_rule_file_covers_attachment4_outline():
rule_set = load_rule_file()
requirements = rule_set["requirements"]
outline = json.loads(Path("tests/fixtures/regulatory/attachment4_outline.json").read_text(encoding="utf-8"))
for chapter in outline:
chapter_rule = next(
item for item in requirements if item["title"] == chapter["title"] and item.get("attachment4_code") == chapter["code"]
)
assert chapter_rule["attachment4_code"] == chapter["code"]
assert chapter_rule["severity"] == "high"
assert chapter_rule["citation_query"]
for child in chapter["children"]:
child_rule = next(
item
for item in requirements
if item["title"] == child and str(item.get("attachment4_code", "")).startswith(f"{chapter['code']}.")
)
assert child_rule["rule_id"]
assert child_rule["file_keywords"]
assert child_rule["severity"] in {"blocking", "high", "medium"}
assert child_rule["citation_query"]
def test_compute_file_sha256_changes_when_file_changes(tmp_path):
path = tmp_path / "rule.yaml"
path.write_text("code: demo\n", encoding="utf-8")

12
tests/test_regulatory_structure.py
View File

@@ -11,3 +11,15 @@ def test_structure_check_reports_missing_instruction_sections():
assert any(finding.rule_code == "instructions_for_use:储存条件" for finding in findings)
assert all("样本要求" not in finding.title for finding in findings)
def test_structure_check_reports_missing_attachment4_outline_heading():
document_texts = {
"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"
}
findings = run_structure_check(document_texts, load_rule_file())
missing = next(finding for finding in findings if finding.rule_code == "attachment4_4_clinical_evaluation")
assert missing.category == "structure"
assert missing.evidence["expected_title"] == "临床评价资料"

3
tests/test_regulatory_workflow.py
View File

@@ -7,6 +7,7 @@ from review_agent.models import (
FileSummaryItem,
Message,
RegulatoryIssue,
RegulatoryArtifact,
RegulatoryReviewBatch,
WorkflowEvent,
WorkflowNodeRun,
@@ -201,4 +202,6 @@ def test_workflow_generates_issues_exports_and_assistant_summary(settings, tmp_p
workflow_type="regulatory_review",
workflow_batch_id=batch.pk,
).count() == 3
assert RegulatoryArtifact.objects.filter(batch=batch, name="text_extract_status.json").exists()
assert RegulatoryArtifact.objects.filter(batch=batch, name="rag_result_json.json").exists()
assert conversation.messages.filter(role=Message.Role.ASSISTANT, content__contains="已完成 NMPA").exists()