指导原则
数据库目前收载了2万余条指导原则，包括了国内外（中国、美国、欧洲、WHO等）权威部门（政府机关、NMPA、FDA等）的药政法规、技术指导、卫生防疫、大健康战略等多维度的指导信息。内容丰富、详实、准确，是用户及时应对疾病风险，预测行业动态，把握政策走向提供不可或缺的助力。
指导原则
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2025-12-09
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热门政策标签
中国指导原则
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国家卫生健康委办公厅关于印发医疗机构卒中中心建设与管理指导原则(2026年版)的通知
2026-07-28
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国家药监局器审中心关于发布心磁信号采集设备注册审查指导原则等57项指导原则的通告(2026年第24号)
2026-07-21
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国家药监局药审中心关于发布<生物制品批准后药学变更管理方案技术指导原则>的通告(2026年第41号)
2026-07-17
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国家药监局器审中心关于发布<中心静脉导管注册审查指导原则(2026年修订版)>的通告(2026年第23号)
2026-07-15
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国家药监局药审中心关于发布<基因治疗药品范围和归类技术指导原则(2026年版)>的通告(2026年第40号)
2026-07-03
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国家药监局药审中心关于发布<细胞治疗药品范围和归类技术指导原则(2026年版)>的通告(2026年第39号)
2026-07-03
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国家药监局器审中心关于发布<基于高通量测序法的胎儿染色体非整倍体(t21、t18、t13)检测试剂盒注册审查指导原则(2026年修订版)>等2项注册审查指导原则的通告(2026年第22号)
2026-07-02
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国家药监局关于发布<脑机接口医疗器械产品分类界定指导原则><脑机接口医疗器械通用名称命名指导原则>等2项医疗器械产品指导原则的通告(2026年第24号)
2026-06-30
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关于公开征求<以患者为中心创新药研发统计方法学技术指导原则(征求意见稿)>意见的通知
2026-06-25
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关于公开征求<斑秃治疗药物临床试验技术指导原则>(征求意见稿)意见的通知
2026-06-24
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国家药监局器审中心关于发布医用磁共振成像系统注册审查指导原则(2026年修订版)的通告(2026年第21号)
2026-06-23
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国家药监局器审中心关于发布<hla-b*58:01基因检测试剂注册审查指导原则>的通告(2026年第17号)
2026-06-15
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国家药监局药审中心关于发布<预防用mrna疫苗临床试验技术指导原则(试行)>的通告(2026年第38号)
2026-06-01
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国家药监局药审中心关于发布<关于开发适宜药品包装规格的指导原则>的通告(2026年第37号)
2026-06-01
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国家药监局关于适用<m13a:口服固体速释制剂的生物等效性>国际人用药品注册技术协调会指导原则的公告(2026年第49号)
2026-05-25
美国指导原则
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determining whether to submit an anda or a 505(b)(2) application(确定是提交仿制药申请(anda)还是505(b)(2)申请)
2026-08-17
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cvm gfi #260 - type vii veterinary master file for research and development and risk reviews(cvm行业指南第260号——用于研发与风险审查的vii型兽药主文件)
2026-08-14
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container closure systems for human drugs and biological products(人用药品和生物制品的容器密闭系统)
2026-08-13
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formal meetings between the fda and sponsors or applicants of pdufa products(关于fda与处方药使用者付费法案(pdufa)产品申办方或申请人之间正式会议的指南)
2026-08-12
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hemodialysis blood tubing sets - premarket notification (510(k)) submissions: guidance for industry and food and drug administration staff(血液透析血液管路套装 - 上市前通知(510(k))申报资料:行业和食品药品监督管理局工作人员指南)
2026-07-23
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opioid analgesic drugs: considerations for benefit-risk assessment framework(阿片类镇痛药:效益-风险评估框架的考量)
2026-05-13
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development of non-opioid analgesics for acute pain(急性疼痛的非阿片类镇痛药开发)
2026-05-13
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development of local anesthetic drug products with prolonged duration of effect(延长作用时间的局部麻醉药品的开发)
2026-05-13
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stimulant use disorders: developing drugs for treatment(兴奋剂使用障碍:治疗药物的开发)
2026-05-13
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development of non-opioid analgesics for chronic pain(慢性疼痛非阿片类镇痛药的开发)
2026-05-13
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pulmonary tuberculosis: developing drugs for treatment(肺结核:治疗药物的开发)
2026-05-08
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clostridioides difficile infection: developing drugs for treatment, reduction of recurrence, and prevention(艰难梭菌感染:用于治疗、减少复发及预防的药物开发)
2026-05-08
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enforcement priorities for certain new tobacco products marketed without premarket authorization(未经上市前授权销售的某些新烟草产品的执法重点)
2026-05-08
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postapproval pregnancy safety studies(上市后妊娠安全性研究)
2026-05-08
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patient-matched guides for orthopedic implants: guidance for industry and food and drug administration staff(骨科植入物的患者匹配指南:行业和食品药品监督管理局工作人员指南)
2026-05-07
欧洲指导原则
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concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients(关于制定支持儿科患者抗癌药物开发的概念验证数据反思文件的概念文件)
2026-03-13
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overview of comments received on the draft reflection paper on the qualification of non-mutagenic impurities(关于非致突变性杂质界定问题的征求意见稿所获意见综述)
2026-03-13
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eu implementation strategy of ich e2d(r1) guideline - post-approval safety data: definitions and standards for management and reporting of individual case safety reports(ich e2d(r1) 指导原则在欧盟的实施策略——上市后安全性数据:个例安全性报告的管理与报告定义及标准)
2026-03-06
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guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis(治疗囊性纤维化药品临床研究指导原则)
2026-03-02
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draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products(关于制定微生态药物非临床研发与评价思考文件的概念性文件草案)
2026-03-02
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overview of comments on ich m4q(r2) : guideline on the common technical document for the registration of pharmaceuticals for human use - quality - step 2b(关于ich m4q(r2)<人用药品注册通用技术文档——质量部分>指导原则(第2b阶段)的意见概述)
2026-02-20
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overview of comments received on ich e20 guideline on adaptive designs for clinical trials (ema/chmp/ich/206586/2025)(关于ich e20<临床试验适应性设计指导原则>(ema/chmp/ich/206586/2025)的意见概述)
2026-02-16
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concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of myasthenia gravis(关于制定重症肌无力治疗药物临床研究指导原则的必要性概念文件)
2026-02-13
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concept paper on revision of the guidelines on good manufacturing practice for medicinal products - annex 6 manufacture of medicinal gases(关于修订<药品生产质量管理规范指南——附件6:医用气体生产>的概念文件)
2026-02-11
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ich m15 guideline on general principles for model-informed drug development - step 5(ich m15<模型引导的药物研发通用原则指导原则>- 第5阶段)
2026-02-11
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overview of comments received on q&a regarding co-processed excipients used in solid oral dosage forms h and v (ema/chmp/cvmp/qwp/422493/2024)(关于固体口服制剂h & v中使用的共处理辅料的问答意见概述(ema/chmp/cvmp/qwp/422493/2024))
2026-01-28
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questions and answers regarding co-processed excipients used in solid oral dosage forms (h & v)(关于在固体口服制剂中使用的共处理辅料的问答(h & v))
2026-01-28
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overview of comments received on on ich q3e guideline and supporting documentation for extractables and leachables (ema/chmp/ich/236669/2025 and ema/chmp/ich/236668/2025)(关于ich q3e指南和支持文件中提取物和浸出物的意见概述(ema/chmp/ich/236669/2025和ema/chmp/ich/236668/2025))
2026-01-28
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overview of comments received on q&a regarding co-processed excipients used in solid oral dosage forms h and v (ema/chmp/cvmp/qwp/422493/2024)(关于口服固体制剂用共处理辅料(h和v)问答文件(ema/chmp/cvmp/qwp/422493/2024)的意见概述)
2026-01-28
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overview of comments received on guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities(关于治疗下肢周围动脉闭塞性疾病药物临床研究指南的意见综述)
2026-01-27
日本指导原则
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GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
2020-10-30
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Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2
2020-09-02
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Quality Management System Inspection of Medical Devices and in-vitro Diagnostics in Japan
2015-04-01
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Guideline on Revision of Precautions and other information
2014-11-20
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2014获批新药NewDrugsApprovedin2014
2014-01-01
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风险管理计划PublicationofRiskManagementPlan
2013-01-01
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用于新药申请提交的通用技术文件格式FormatforPreparingtheCommonTechnicalDocumentforSubmissionofNewDrugApplications
2011-01-01
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Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs
2010-10-21
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口服降糖药的临床评价指标OnReleaseoftheGuidelineforClinicalEvaluationofOralHypoglycemicAgents
2010-01-01
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销售授权中计算机系统管理指南GuidelineonManagementofComputerizedSystemsforMarketingAuthorization
2010-01-01
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GMP合规检查的文档准备DocumentsRequiredbyPMDAfortheApplicationofGMPComplianceInspection
2010-01-01
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周期性GMP合规检查应用程序所需的文件DocumentationRequiredfortheApplicationofPeriodicGMPComplianceInspection
2010-01-01
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周期性GMP合规检查所需的文件DocumentationRequiredforPeriodicGMPComplianceInspection
2010-01-01
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授权产品中心取样及测试的一般程序GeneralProcedureforSampling&TestingofCentrallyAuthorisedProducts
2010-01-01
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柳氮磺胺吡啶在实验室试验前后的行为依从性Compliancewithconductoflaboratorytestsbeforeandafteradministrationofsalazosulfapyridine
2010-01-01