[B019] 药物批准信息的接口地址是什么？

[B019] 药物批准信息的接口为 GET https://connect.zhihuiya.com/synapse/drug/approval。

[B019] 药物批准信息可以返回哪些数据？

[B019] 药物批准信息：获取药物批准信息，包括产品信息、审批信息等。完整响应结构请参见本页的响应结构与成功响应示例。

在哪里可以找到 [B019] 药物批准信息的 OpenAPI schema？

OpenAPI schema 位于 /openapi.json#/paths/~1synapse~1drug~1approval/get，也可在 /openapi.json 浏览完整规范。

[B019] 药物批准信息

Q: [B019] 药物批准信息 的接口地址是什么？

[B019] 药物批准信息 的接口为 GET https://connect.zhihuiya.com/synapse/drug/approval。

get

https://connect.zhihuiya.com/synapse/drug/approval

在体验中心中试用

获取药物批准信息，包括产品信息、审批信息等

请求参数

此 API 接口支持的参数列表

名称	类型	示例	描述
`drug_id` 必填	`string`	`68431d4745744d9e9e17a3073edd3920`	药物id，通过药物搜索接口或药物自动补全接口获取

响应结构

API 响应数据的结构说明

字段名	类型	示例	描述
`data`	`object`	-	响应数据
`ema`	`object`	`Please check the form:DrugApprovalEmaDto`	EMA
`products`	`array`	`Please check the form:ApprovalProductDto`	产品信息
`appl_no`	`string`	`125057`	FDA 申请号
`generic`	`integer<int32>`	-	仿制药, 0：否， 1：是
`strength`	`string`	`40MG/0.8ML`	规格
`appl_type`	`string`	`BLA`	申请类型
`pack_size`	`string`	`25854e08d0e9858e89ad4438028589d2`	包装规格
`biosimilar`	`integer<int32>`	-	生物类似药, 0：否， 1：是
`product_no`	`string`	`25854e08d0e9858e89ad4438028589d2`	EMA 申请号
`trade_name`	`array`	`[ { "lang": "EN", "name": "HUMIRA" } ]`	商品名
`lang`	`string`	`EN`	语言
`name`	`string`	`Ranibizumab (Genentech)`	药物、靶点、机构、适应症、国家/地区、字典、作用机制名称
`data_source`	`string`	`FDA_CDER`	数据来源
`approval_date`	`integer<int64>`	`25854e08d0e9858e89ad4438028589d2`	批准日期
`market_status`	`object`	`{ "display_name": [ { "lang": "EN", "name": "Approved" }, { "lang": "CN", "name": "批准上市" } ], "normalized_id": "42d0efa0fd1a48aea4913755067bc043" }`	市场状态
`display_name`	`array`	`[ { "lang": "EN", "name": "Autologous CAR-T" }, { "lang": "CN", "name": "自体CAR-T" } ]`	字典名称
`normalized_id`	`string`	`2fbfdb3e92d942c48cbb0adb79f23526`	字典ID
`special_review`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "Additional Monitoring" }, { "lang": "CN", "name": "额外监测" } ], "normalized_id": "30ffad249563481eb8fcfe4a7342269a" } ]`	特殊审评
`applicant_holder`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "AbbVie, Inc." } ], "organization_id": "d88590e686ad5608bbbfeb811b14d188" } ]`	申请机构
`display_name`	`array`	`[ { "lang": "EN", "name": "Roche Holding AG" }, { "lang": "CN", "name": "罗氏" } ]`	机构名称，引用“CommonName”
`organization_id`	`string`	`87bfaf037f8e60c9e25595cd98bb27e4`	机构ID
`drug_approval_id`	`string`	`25854e08d0e9858e89ad4438028589d2`	药物批准ID
`last_update_date`	`integer<int64>`	`1722384000000`	最近更新
`first_approval_date`	`integer<int64>`	`25854e08d0e9858e89ad4438028589d2`	首批日期
`product_data_source`	`array`	`[ { "lang": "EN", "name": "Orange Book" }, { "lang": "CN", "name": "橙皮书" } ]`	产品数据来源
`product_presentation`	`string`	`Blister (PVC/PE/PVDC/alu)`	包装类型
`content_concentration`	`string`	`0.8 ml (40 mg/0.8 ml)`	容量
`dosage_form_and_route`	`object`	`Please check the form:ApprovalSubmissionDto`	剂型 & 给药途径
`route`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "Subcutaneous" }, { "lang": "CN", "name": "皮下注射" } ], "normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac" } ]`	给药途径
`dosage_from`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "Injection" }, { "lang": "CN", "name": "注射剂" } ], "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ]`	Dosage Form
`original_name`	`string`	`Injection; Subcutaneous`	原始值
`submissions`	`array`	`Please check the form:ApprovalSubmissionDto`	批准信息
`disease`	`array`	`[ { "disease_id": "e6ee5660ea1d44ad8edb142046da866f", "display_name": [ { "lang": "EN", "name": "Enthesitis-Related Arthritis" }, { "lang": "CN", "name": "附着点炎相关关节炎" } ] } ]`	适应症
`disease_id`	`string`	`06a9082fe1ec4c97bea31d888b9cfdce`	适应症ID
`display_name`	`array`	`[ { "lang": "EN", "name": "Uveitic Macular Edema" }, { "lang": "CN", "name": "葡萄膜炎黄斑水肿" } ]`	适应症名称，引用“CommonName”
`regulation`	`array`	`STANDARD; Orphan`	审评分类
`action_date`	`integer<int64>`	`1698969600000`	EMA批准日期
`action_type`	`string`	`Approval`	审批结论
`approval_date`	`integer<int64>`	`1698969600000`	FDA批准日期
`market_status`	`object`	`{ "display_name": [ { "lang": "EN", "name": "Approved" }, { "lang": "CN", "name": "批准上市" } ], "normalized_id": "42d0efa0fd1a48aea4913755067bc043" }`	市场状态
`submission_no`	`integer<int64>`	`423`	文件提交号
`submission_type`	`string`	`SUPPL`	文件提交类型
`drug_approval_id`	`string`	`25854e08d0e9858e89ad4438028589d2`	药物批准ID
`original_regulation`	`string`	`STANDARD; Orphan`	审评分类原始值
`submission_classification`	`string`	`Labeling`	注册分类
`fda`	`object`	`Please check the form:DrugApprovalFdaDto`	FDA
`products`	`array`	`Please check the form:ApprovalProductDto`	产品信息
`submissions`	`array`	`Please check the form:ApprovalSubmissionDto`	批准信息
`nmpa`	`object`	`Please check the form:DrugApprovalNmpaDto`	NMPA
`products`	`array`	`Please check the form:ApprovalProductDto`	产品信息
`pmda`	`object`	`Please check the form:DrugApprovalPmdaDto`	PMDA
`products`	`array`	`Please check the form:ApprovalProductDto`	产品信息
`status` 必填	`boolean`	`false`	状态
`error_msg`	`string`	`The request parameter format is incorrect！`	错误信息
`error_code` 必填	`integer`	`0`	错误代码

成功响应示例

成功调用 API 的响应示例

JSON

{
  "data": {
    "ema": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ],
      "submissions": [
        {
          "disease": [
            {
              "disease_id": "06a9082fe1ec4c97bea31d888b9cfdce",
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ]
            }
          ],
          "regulation": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "action_date": 1698969600000,
          "action_type": "Approval",
          "approval_date": 1698969600000,
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "submission_no": 423,
          "submission_type": "SUPPL",
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "original_regulation": "STANDARD; Orphan",
          "submission_classification": "Labeling"
        }
      ]
    },
    "fda": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ],
      "submissions": [
        {
          "disease": [
            {
              "disease_id": "06a9082fe1ec4c97bea31d888b9cfdce",
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ]
            }
          ],
          "regulation": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "action_date": 1698969600000,
          "action_type": "Approval",
          "approval_date": 1698969600000,
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "submission_no": 423,
          "submission_type": "SUPPL",
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "original_regulation": "STANDARD; Orphan",
          "submission_classification": "Labeling"
        }
      ]
    },
    "nmpa": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ]
    },
    "pmda": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ]
    }
  },
  "status": true,
  "error_code": 0
}

错误码

此接口可能返回的错误码列表

业务错误码

错误码	描述
`68300004`	请求参数异常!
`68300005`	查询Api失败!
`68300006`	解析基本存取错误!
`68300007`	存在错误的请求!
`68300008`	服务中断异常，请稍后再试!
`68300010`	文件不符合上传规范!

平台错误码

错误码	描述
`67200001`	API整体限流错误!
`67200002`	用户调用请求限流限制错误!
`67200003`	申请token的key和secret不正确或者状态错误!
`67200004`	无权限或该接口的套餐已超过系统设置的上限!
`67200005`	账户余额不足，调用失败!
`67200006`	客户端已过期，调用失败!
`67200007`	超过调用额度，调用失败!

HTTP 状态码

状态码	描述
`0`	请求成功
`401`	Unauthorized
`403`	Forbidden
`404`	Not Found

性能指标

此接口的预期性能特征

正常响应时间

5000 ms

最大响应时间

10000 ms