feat(regulatory): 增加适用条件确认暂停恢复

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"

review_agent/regulatory_review/views.py

@@ -1,10 +1,15 @@
 from __future__ import annotations
 
+import json
+
+from django.conf import settings
 from django.http import Http404, JsonResponse
 from django.views.decorators.http import require_http_methods
 from django.contrib.auth.decorators import login_required
 
 from review_agent.models import RegulatoryReviewBatch, WorkflowNodeRun
+from review_agent.regulatory_review.events import record_event
+from review_agent.regulatory_review.workflow import start_regulatory_review_workflow
 
 
 @require_http_methods(["GET"])
@@ -43,6 +48,59 @@ def batch_status(request, batch_id: int):
     )
 
 
+@require_http_methods(["POST"])
+@login_required
+def confirm_conditions(request, batch_id: int):
+    batch = RegulatoryReviewBatch.objects.filter(pk=batch_id, user=request.user).first()
+    if not batch:
+        raise Http404("批次不存在。")
+    try:
+        payload = json.loads(request.body.decode("utf-8") or "{}")
+    except json.JSONDecodeError:
+        return JsonResponse({"error": "请求体不是有效 JSON。"}, status=400)
+    conditions = payload.get("conditions")
+    if not isinstance(conditions, dict):
+        return JsonResponse({"error": "conditions 必须是对象。"}, status=400)
+
+    batch.condition_json = {
+        **(batch.condition_json or {}),
+        "confirmed": True,
+        "confirmed_conditions": _normalize_conditions(conditions),
+    }
+    batch.status = RegulatoryReviewBatch.Status.RUNNING
+    batch.save(update_fields=["condition_json", "status"])
+    WorkflowNodeRun.objects.filter(
+        workflow_type="regulatory_review",
+        workflow_batch_id=batch.pk,
+        node_code="condition_confirm",
+    ).update(
+        status=WorkflowNodeRun.Status.SUCCESS,
+        progress=100,
+        message="适用条件已确认",
+    )
+    record_event(
+        batch,
+        "condition_confirmed",
+        {"conditions": batch.condition_json["confirmed_conditions"], "resume_from": "rule_scope"},
+    )
+    start_regulatory_review_workflow(
+        batch,
+        async_run=getattr(settings, "REGULATORY_REVIEW_ASYNC", True),
+    )
+    batch.refresh_from_db()
+    return JsonResponse(
+        {
+            "batch": {
+                "id": batch.pk,
+                "workflow_type": "regulatory_review",
+                "batch_no": batch.batch_no,
+                "status": batch.status,
+                "condition_json": batch.condition_json,
+            }
+        }
+    )
+
+
 def _format_risk_summary(risk_summary: dict) -> str:
     labels = [
         ("blocking", "阻断项"),
@@ -56,3 +114,15 @@ def _format_risk_summary(risk_summary: dict) -> str:
         for key, label in labels
         if int(risk_summary.get(key) or 0)
     )
+
+
+def _normalize_conditions(conditions: dict) -> dict[str, str]:
+    allowed = [
+        "product_category",
+        "registration_type",
+        "clinical_evaluation_path",
+        "product_name",
+        "model_spec",
+        "intended_use",
+    ]
+    return {key: str(conditions.get(key) or "").strip() for key in allowed}

review_agent/regulatory_review/workflow.py

@@ -19,6 +19,7 @@ from review_agent.models import (
 from review_agent.regulatory_review.services.completeness_check import run_completeness_check
 from review_agent.regulatory_review.services.consistency_check import run_consistency_check
 from review_agent.regulatory_review.services.export import build_assistant_summary, export_review_results
+from review_agent.regulatory_review.services.info_extract import detect_regulatory_condition_candidates
 from review_agent.regulatory_review.services.risk_assess import persist_findings
 from review_agent.regulatory_review.services.rule_loader import load_rule_file
 from review_agent.regulatory_review.services.structure_check import run_structure_check
@@ -29,6 +30,7 @@ from .events import record_event
 
 NODE_DEFINITIONS = [
     ("prepare", "准备", "prepare"),
+    ("condition_confirm", "适用条件确认", "condition_confirm"),
     ("rule_scope", "规则范围", "rule_scope"),
     ("completeness_check", "完整性核查", "completeness_check"),
     ("text_extract", "文本抽取", "text_extract"),
@@ -43,6 +45,10 @@ NODE_DEFINITIONS = [
 logger = logging.getLogger("review_agent.regulatory_review.workflow")
 
 
+class WorkflowPausedForUser(Exception):
+    pass
+
+
 def build_batch_no() -> str:
     return f"RR-{timezone.localtime().strftime('%Y%m%d%H%M%S')}-{uuid4().hex[:6]}"
 
@@ -108,7 +114,11 @@ class RegulatoryWorkflowExecutor:
 
         try:
             for node in self._nodes():
+                if node.status == WorkflowNodeRun.Status.SUCCESS:
+                    continue
                 self._run_node(node)
+        except WorkflowPausedForUser:
+            return
         except Exception as exc:
             logger.exception("Regulatory workflow failed", extra={"batch_id": self.batch.pk})
             self.batch.status = RegulatoryReviewBatch.Status.FAILED
@@ -155,6 +165,9 @@ class RegulatoryWorkflowExecutor:
         )
 
     def _execute_node(self, node_code: str) -> None:
+        if node_code == "condition_confirm":
+            self._pause_for_condition_confirmation()
+            return
         if node_code == "rule_scope":
             self.rule_set = load_rule_file()
             return
@@ -181,6 +194,34 @@ class RegulatoryWorkflowExecutor:
                 content=build_assistant_summary(self.batch, exports),
             )
 
+    def _pause_for_condition_confirmation(self) -> None:
+        if self.batch.condition_json.get("confirmed"):
+            return
+        candidates = detect_regulatory_condition_candidates(self.batch.source_summary_batch)
+        self.batch.condition_json = {
+            **(self.batch.condition_json or {}),
+            "confirmed": False,
+            "resume_from": "rule_scope",
+            "candidates": candidates,
+        }
+        self.batch.status = RegulatoryReviewBatch.Status.WAITING_USER
+        self.batch.save(update_fields=["status", "condition_json"])
+        node = WorkflowNodeRun.objects.get(
+            workflow_type="regulatory_review",
+            workflow_batch_id=self.batch.pk,
+            node_code="condition_confirm",
+        )
+        node.status = WorkflowNodeRun.Status.WAITING_USER
+        node.progress = 50
+        node.message = "请确认产品类别、注册类型、临床评价路径等适用条件"
+        node.save(update_fields=["status", "progress", "message"])
+        record_event(
+            self.batch,
+            "waiting_user",
+            {"node_code": "condition_confirm", "candidates": candidates, "resume_from": "rule_scope"},
+        )
+        raise WorkflowPausedForUser()
+
     def _rules(self) -> dict:
         if self.rule_set is None:
             self.rule_set = load_rule_file()