feat(regulatory): 增加适用条件确认暂停恢复

2026-06-07 09:19:31 +08:00
parent bd805203f1
commit bbd2d3532a
12 changed files with 535 additions and 1 deletions
--- a/review_agent/regulatory_review/services/info_extract.py
+++ b/review_agent/regulatory_review/services/info_extract.py
@@ -0,0 +1,81 @@
+from __future__ import annotations
+
+from review_agent.models import FileSummaryBatch
+
+
+OPTION_FIELDS = {
+    "product_category": ["体外诊断试剂", "医疗器械", "其他"],
+    "registration_type": ["首次注册", "变更注册", "延续注册"],
+    "clinical_evaluation_path": ["临床试验", "免临床", "同品种比对", "待确认"],
+}
+
+
+def detect_regulatory_condition_candidates(summary_batch: FileSummaryBatch) -> dict[str, dict[str, object]]:
+    """Infers review-scope conditions from the summary batch and file names."""
+
+    corpus_parts = [summary_batch.product_name or ""]
+    for item in summary_batch.items.order_by("file_index"):
+        corpus_parts.extend([item.directory_level, item.file_name, item.relative_path])
+    corpus = "\n".join(part for part in corpus_parts if part)
+
+    return {
+        "product_category": {
+            "label": "产品类别",
+            "input_type": "select",
+            "options": OPTION_FIELDS["product_category"],
+            "suggested": _detect_product_category(corpus),
+        },
+        "registration_type": {
+            "label": "注册类型",
+            "input_type": "select",
+            "options": OPTION_FIELDS["registration_type"],
+            "suggested": _detect_registration_type(corpus),
+        },
+        "clinical_evaluation_path": {
+            "label": "临床评价路径",
+            "input_type": "select",
+            "options": OPTION_FIELDS["clinical_evaluation_path"],
+            "suggested": _detect_clinical_path(corpus),
+        },
+        "product_name": {
+            "label": "产品名称",
+            "input_type": "text",
+            "suggested": summary_batch.product_name or "",
+        },
+        "model_spec": {
+            "label": "型号规格",
+            "input_type": "text",
+            "suggested": "",
+        },
+        "intended_use": {
+            "label": "预期用途",
+            "input_type": "text",
+            "suggested": "",
+        },
+    }
+
+
+def _detect_product_category(corpus: str) -> str:
+    if any(keyword in corpus for keyword in ["体外诊断", "检测试剂", "试剂盒", "IVD"]):
+        return "体外诊断试剂"
+    if "医疗器械" in corpus:
+        return "医疗器械"
+    return "其他"
+
+
+def _detect_registration_type(corpus: str) -> str:
+    if "延续" in corpus:
+        return "延续注册"
+    if "变更" in corpus:
+        return "变更注册"
+    return "首次注册"
+
+
+def _detect_clinical_path(corpus: str) -> str:
+    if "免临床" in corpus or "免于临床" in corpus:
+        return "免临床"
+    if "同品种" in corpus or "同类" in corpus:
+        return "同品种比对"
+    if "临床试验" in corpus:
+        return "临床试验"
+    return "待确认"