中国药品审评

概述

接口通过受理号获取详细信息，数据综合了国家药监局与药审中心等多个部门的官方数据库信息，收录了药品审评中心公布的全部受理号及其办理状态，包括国内新药注册申报、补充申请、进口等情况；同时收录了优先审评、突破性治疗等特殊审评品种，并经过系统整理，深度加工，为了解潜在竞争产品及其目前状况，预测竞品上市时间，提供决策支持。

数据结构

{
    "target_short": [
        "简化靶点"
    ],
    "atc_grade_cn": [
        "ATC大类"
    ],
  "company":"企业名称",
    "atc_class_cn": [
        "ATC亚类"
    ],
    "active_ingredient_cn": "活性成分（中）",
    "active_ingredient_en": "活性成分（英）",
    "target": [
        "靶点"
    ],
    "manufacturer": [
        "NMPA企业名称"
    ],
    "report_indication": [
        "受理号适应症"
    ],
    "approval_number": [
        "批准文号"
    ],
    "company_cde": [
        "CDE原企业名称"
    ],
    "formulation_type": "单方/复方类型",
    "sequence_status": "序列状态",
    "last_update_date": "最新状态日期",
    "review_province": "受理局省份",
    "bool_recall": "是否CDE已撤回",
    "conclusion_date": "审评结论日期",
    "enter_supplement_date": "进入补充日期",
    "enter_newcomer_date": "进入新报日期",
    "bool_conditional_approval": "附条件批准",
    "bool_clinical_urgent": "临床急需境外新药",
    "type": "一致性评价类型",
    "direct_approval_date": "直接行政审批",
    "license_clinical_date": "默示许可时间",
    "strength": "规格",
    "bool_instruction": "说明书",
    "bool_review": "审判报告",
    "bool_direct": "是否直接行政审批",
    "bool_license": "是否临床默示许可",
    "breakthrough_treatment": "是否突破性治疗品种",
    "license_indication": "临床默示许可适应症",
    "review_conclusions": "审评结论",
    "registration_classification": "注册类型",
    "province": "省份",
    "processing_status": "办理状态",
    "drug_type_guifan": "药品类型（规范）",
    "dosage_form_2": "剂型（二级）",
    "dosage_form_1": "剂型(一级）",
    "delivery_route": "给药途径",
    "application_type_parent": "受理号申请类型",
    "drug_name_standard": "药品标准名称",
    "consistency_evaluation": "是否是一致性评价",
    "special_review": "是否特殊审评品种",
    "projects": "是否重大专项品种",
    "priority_review": "是否纳入优先审评",
    "application_type": "受理号申请类型",
    "drug_type": "药品类型",
    "undertake_date": "承办日期",
    "registration_classification_child": "注册类型",
    "application_type_child": "申报内容",
    "drug_name": "药品名称",
    "acceptances_number": "受理号"
}

数据样例

{
    "target_short": ["HCV NS5B"],
    "atc_grade_cn": ["系统用抗感染药物"],
  "company": "Gilead Sciences International Ltd.",
    "atc_class_cn": ["系统用抗病毒药"],
    "active_ingredient_cn": "索磷布韦",
    "active_ingredient_en": "sofosbuvir",
    "target": ["Hepatitis C virus NS5B polymerase（HCV NS5B）"],
    "manufacturer": ["香港吉立亚科学有限公司北京代表处"],
    "report_indication": ["本品适于与其他药品联合使用，治疗成人与12至<18岁青少年的慢性丙型肝炎病毒(HCV)感染。"],
    "approval_number": ["H20170365"],
    "company_cde": ["Gilead Sciences International Ltd.", "Gilead Sciences Ireland UC"],
    "formulation_type": "单方/单组分",
    "sequence_status": "已完成审评",
    "last_update_date": "2017-09-25",
    "review_province": "国家局",
    "bool_recall": "否",
    "conclusion_date": "2017-09-20",
    "enter_supplement_date": "2017-05-26",
    "enter_newcomer_date": "2017-03-16",
    "bool_conditional_approval": "否",
    "bool_clinical_urgent": "否",
    "type": "",
    "direct_approval_date": "",
    "license_clinical_date": "",
    "strength": "400mg",
    "bool_instruction": "有",
    "bool_review": "有",
    "bool_direct": "否",
    "bool_license": "否",
    "breakthrough_treatment": "否",
    "license_indication": "",
    "review_conclusions": "批准进口",
    "registration_classification": "5类",
    "province": "国",
    "processing_status": "已发件",
    "drug_type_guifan": "化学药",
    "dosage_form_2": "片剂",
    "dosage_form_1": "片剂",
    "delivery_route": "口服",
    "application_type_parent": "进口化药申请销售",
    "drug_name_standard": "索磷布韦片",
    "consistency_evaluation": "否",
    "special_review": "否",
    "projects": "否",
    "priority_review": "正式纳入",
    "application_type": "申请上市",
    "drug_type": "化药",
    "undertake_date": "2017-03-15",
    "registration_classification_child": "5.1",
    "application_type_child": "进口",
    "drug_name": "索磷布韦片",
    "acceptances_number": "JXHS1700011"
}