From 48d94884b9baf0f87c9b357c0a064ced1aff69ba Mon Sep 17 00:00:00 2001
From: bruce <sunzhiye01@outlook.com>
Date: Sun, 7 Jun 2026 10:31:39 +0800
Subject: [PATCH] =?UTF-8?q?docs(regulatory):=20=E8=A1=A5=E5=85=85=E7=AC=AC?=
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MIME-Version: 1.0
Content-Type: text/plain; charset=UTF-8
Content-Transfer-Encoding: 8bit

---
 .../附件 4 体外诊断试剂注册申报资料要求及说明.doc | Bin 0 -> 58368 bytes
 ...PA注册资料法规核查与整改闭环-第二批完整闭环.md |  92 +++++++++++++++---
 2 files changed, 77 insertions(+), 15 deletions(-)
 create mode 100644 docs/0.原始材料/附件 4 体外诊断试剂注册申报资料要求及说明.doc

diff --git a/docs/0.原始材料/附件 4 体外诊断试剂注册申报资料要求及说明.doc b/docs/0.原始材料/附件 4 体外诊断试剂注册申报资料要求及说明.doc
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diff --git a/docs/5.开发计划/2.NMPA注册资料法规核查与整改闭环-第二批完整闭环.md b/docs/5.开发计划/2.NMPA注册资料法规核查与整改闭环-第二批完整闭环.md
index 8875b5e..26f2dba 100644
--- a/docs/5.开发计划/2.NMPA注册资料法规核查与整改闭环-第二批完整闭环.md
+++ b/docs/5.开发计划/2.NMPA注册资料法规核查与整改闭环-第二批完整闭环.md
@@ -7,6 +7,7 @@
 ```text
 适用条件对话选择框
 -> waiting_user 暂停恢复
+-> 附件 4 申报资料目录规则对齐
 -> 整包复核
 -> 缺失项复核
 -> mock 通知留痕
@@ -23,7 +24,7 @@
 | 阶段 | 名称 | 目标 | 验收 |
 | --- | --- | --- | --- |
 | RR2-1 | 适用条件确认 | 对话选择框确认产品类别、注册类型、临床评价路径等 | waiting_user 可暂停恢复 |
-| RR2-2 | 核查能力增强 | 扩展章节、一致性、RAG 引用和文本抽取范围 | 复杂样例可识别更多问题 |
+| RR2-2 | 附件 4 规则对齐与核查能力增强 | 按《体外诊断试剂注册申报资料要求及说明》扩展完整目录规则、章节、一致性、RAG 引用和文本抽取范围 | 能识别附件 4 一级/二级目录缺失和关键字段问题 |
 | RR2-3 | 整包复核 | 基于新的汇总批次创建新的法规核查批次 | 可追溯来源批次 |
 | RR2-4 | 缺失项复核 | 针对原 Issue 执行复核并更新状态 | 生成 review_record |
 | RR2-5 | mock 通知留痕 | 对 blocking/high/medium 写 mock 通知记录 | 报告展示通知记录 |
@@ -71,29 +72,89 @@ pytest tests/test_regulatory_condition.py tests/test_regulatory_frontend.py test
 
 ---
 
-## 四、RR2-2 核查能力增强
+## 四、RR2-2 附件 4 规则对齐与核查能力增强
+
+### 新增口径：附件 4 必须结构化入规则库
+
+第一批主链路已经可以演示，但现有 Demo YAML 只覆盖 5 类规则：产品技术要求、说明书、注册检验报告、临床评价资料、安全和性能基本原则清单。经人工确认，第一批链路可通过；但与附件《体外诊断试剂注册申报资料要求及说明》相比，规则覆盖仍不完整。第二批 RR2-2 必须将附件 4 的申报资料目录结构补入规则库，并作为完整性和章节核查的主要依据。
+
+附件来源：
+
+```text
+docs/0.原始材料/附件 4 体外诊断试剂注册申报资料要求及说明.doc
+```
+
+如附件仍为旧版 `.doc`，允许在开发阶段通过 Pandoc、LibreOffice headless、Word COM 或受控脚本转换为 `.docx`/`.txt` 中间产物；中间产物只用于规则抽取和测试夹具，不改变第一阶段文件页数统计口径。
+
+### 附件 4 目录覆盖范围
+
+第二批 Demo 规则至少覆盖以下一级和二级标题。规则应支持“章节目录”类目录项、资料文件项、条件适用项和推荐项的区分。
+
+| 一级目录 | 二级目录/资料项 |
+| --- | --- |
+| 1. 监管信息 | 1.1 章节目录、1.2 申请表、1.3 术语/缩写词列表、1.4 产品列表、1.5 关联文件、1.6 申报前与监管机构的联系情况和沟通记录、1.7 符合性声明 |
+| 2. 综述资料 | 2.1 章节目录、2.2 概述、2.3 产品描述、2.4 预期用途、2.5 申报产品上市历史、2.6 其他需说明的内容 |
+| 3. 非临床资料 | 3.1 章节目录、3.2 产品风险管理资料、3.3 体外诊断试剂安全和性能基本原则清单、3.4 产品技术要求及检验报告、3.5 分析性能研究、3.6 稳定性研究、3.7 阳性判断值或参考区间研究、3.8 其他资料 |
+| 4. 临床评价资料 | 4.1 章节目录、4.2 临床评价资料 |
+| 5. 产品说明书和标签样稿 | 5.1 章节目录、5.2 产品说明书、5.3 标签样稿、5.4 其他资料 |
+| 6. 质量管理体系文件 | 6.1 综述、6.2 章节目录、6.3 生产制造信息、6.4 质量管理体系程序、6.5 管理职责程序、6.6 资源管理程序、6.7 产品实现程序、6.8 质量管理体系的测量/分析和改进程序、6.9 其他质量体系程序信息、6.10 质量管理体系核查文件 |
+
+### 规则分级默认值
+
+| 规则类型 | 默认风险 | 说明 |
+| --- | --- | --- |
+| 一级目录整体缺失 | high | 如缺少“监管信息”“综述资料”“非临床资料”等完整章节 |
+| 关键法定资料缺失 | blocking | 申请表、符合性声明、产品技术要求及检验报告等 |
+| 关键技术/评价资料缺失 | high | 产品风险管理资料、分析性能研究、稳定性研究、临床评价资料、产品说明书、标签样稿等 |
+| 条件适用资料缺失 | medium/high | 如上市历史、申报前沟通记录、其他资料；需结合 RR2-1 适用条件判断 |
+| 章节目录缺失 | medium | 各一级目录下的章节目录缺失，影响资料可追溯性 |
+
+### 与现有第一批链路的差异修正
+
+| 当前能力 | 第二批修正 |
+| --- | --- |
+| 完整性核查只按文件名和相对路径匹配 | 增加目录名、首页文本/前若干页文本、章节标题候选匹配 |
+| YAML 只覆盖 5 个 Demo 条目 | 扩展为附件 4 一级/二级目录规则，保留第一批 5 条并映射到附件 4 对应章节 |
+| 章节核查只检查说明书储存条件/有效期/样本要求 | 改为同时检查申报资料目录结构和说明书内部关键章节 |
+| RAG 可能跳过 `.doc` 材料 | 附件 4 必须可被转换或抽取，构建 RAG 前输出可读文本抽取状态 |
+| 一致性只检查产品名称、型号规格、预期用途 | 保留这三项，并增加管理类别、分类编码、注册类型、临床评价路径等候选字段 |
 
 ### 任务
 
 | 编号 | 内容 | 文件 |
 | --- | --- | --- |
-| RR2-2-001 | 扩展 YAML 规则中的必需章节和一致性字段 | `rules/nmpa_ivd_registration_v1.yaml` |
-| RR2-2-002 | 增强文本抽取，缓存章节候选和字段候选 | `services/text_extract.py` |
-| RR2-2-003 | 增强章节核查，支持别名、近似标题和证据片段 | `services/structure_check.py` |
-| RR2-2-004 | 增强一致性核查，支持多个来源值和低置信度提示项 | `services/consistency_check.py` |
-| RR2-2-005 | RAG 引用写入 `rag_result_json` 过程产物 | `services/rag_citation.py`、`storage.py` |
-| RR2-2-006 | 增加测试 | `tests/test_regulatory_structure.py`、`tests/test_regulatory_consistency.py`、`tests/test_regulatory_rag.py` |
+| RR2-2-001 | 将附件 4 `.doc` 抽取为可测试的结构化目录夹具 | `tests/fixtures/regulatory/attachment4_outline.json` 或同等 fixture |
+| RR2-2-002 | 扩展 YAML 规则，覆盖附件 4 一级/二级目录、别名、适用条件、风险等级和整改建议 | `rules/nmpa_ivd_registration_v1.yaml` |
+| RR2-2-003 | 增强规则加载校验，确保附件 4 必填目录项都有规则 ID、关键词、风险等级和 citation_query | `services/rule_loader.py` |
+| RR2-2-004 | 增强完整性核查，支持文件名、目录名、首页文本/前若干页文本、章节标题候选匹配 | `services/completeness_check.py`、`services/text_extract.py` |
+| RR2-2-005 | 增强文本抽取，缓存章节候选、字段候选、首页文本和抽取状态 | `services/text_extract.py`、`storage.py` |
+| RR2-2-006 | 增强章节核查，支持附件 4 目录层级、别名、近似标题和证据片段 | `services/structure_check.py` |
+| RR2-2-007 | 增强一致性核查，支持产品名称、型号规格、预期用途、管理类别、分类编码、注册类型、临床评价路径等来源值 | `services/consistency_check.py` |
+| RR2-2-008 | RAG 引用写入 `rag_result_json` 过程产物，并记录附件 4 文本抽取/索引状态 | `services/rag_citation.py`、`storage.py` |
+| RR2-2-009 | 增加附件 4 对齐测试 | `tests/test_regulatory_rule_loader.py`、`tests/test_regulatory_completeness.py`、`tests/test_regulatory_structure.py`、`tests/test_regulatory_consistency.py`、`tests/test_regulatory_rag.py` |
+
+### 验收样例
+
+| 样例条件 | 预期 |
+| --- | --- |
+| 文件包缺少“监管信息/申请表” | 生成 blocking 或 high 问题，并引用附件 4 监管信息要求 |
+| 文件包缺少“产品风险管理资料” | 生成 high 问题，category 为 completeness |
+| 文件包缺少“分析性能研究”或“稳定性研究” | 生成 high 问题，给出补充研究资料建议 |
+| 文件包有产品技术要求但无检验报告 | 生成 blocking 问题，规则映射到 3.4 |
+| 文件包有产品说明书但无标签样稿 | 生成 high 问题，规则映射到 5.3 |
+| 文件包缺少质量管理体系文件 | 生成 high 问题，规则映射到第 6 章 |
+| 附件 4 `.doc` 未能抽取 | RAG 构建命令失败或明确报告附件 4 抽取失败，不允许静默跳过该核心材料 |
 
 ### 验证命令
 
 ```bash
-pytest tests/test_regulatory_structure.py tests/test_regulatory_consistency.py tests/test_regulatory_rag.py
+pytest tests/test_regulatory_rule_loader.py tests/test_regulatory_completeness.py tests/test_regulatory_structure.py tests/test_regulatory_consistency.py tests/test_regulatory_rag.py
 ```
 
 ### Codex 执行提示
 
 ```text
-请增强章节核查、一致性核查和 RAG 过程产物。证据必须包含文件路径、命中片段、字段名或规则 ID，便于人工复核。
+请先将附件 4《体外诊断试剂注册申报资料要求及说明》结构化为规则覆盖清单，再增强 YAML、完整性核查、章节核查、一致性核查和 RAG 过程产物。第二批必须覆盖附件 4 的 1-6 章一级目录和主要二级目录；证据必须包含文件路径、命中片段、字段名或规则 ID，便于人工复核。附件 4 作为核心法规材料，不允许在 RAG 构建中静默跳过。
 ```
 
 ---
@@ -229,14 +290,15 @@ pytest
 第一批主链路已经完成并通过全量测试。
 
 目标：
-补齐法规核查完整整改闭环，包括适用条件对话选择框、waiting_user 暂停恢复、整包复核、缺失项复核、mock 通知留痕、增强章节/一致性核查和前端交互。
+补齐法规核查完整整改闭环，包括适用条件对话选择框、waiting_user 暂停恢复、附件 4 申报资料目录规则对齐、整包复核、缺失项复核、mock 通知留痕、增强章节/一致性核查和前端交互。
 
 执行规则：
 1. 从第一批完成后的稳定分支创建 codex/YYYYMMDD-NMPA法规核查完整闭环 分支。
 2. 按 RR2-1 到 RR2-6 顺序执行。
 3. 每阶段完成后运行对应验证命令。
-4. 不接真实飞书 CLI/API。
-5. 不做规则管理前端。
-6. 不做自动填写目标文件。
-7. 最后运行 python manage.py check 和 pytest 全量验收。
+4. RR2-2 必须覆盖附件 4 的 1-6 章一级目录和主要二级目录，不能只保留第一批 5 条 Demo 规则。
+5. 不接真实飞书 CLI/API。
+6. 不做规则管理前端。
+7. 不做自动填写目标文件。
+8. 最后运行 python manage.py check 和 pytest 全量验收。
 ```