Confirmation, etc. of the status of pre-approval GMP compliance inspection for new drugs
2017-09-19
/
其他
日本
现行有效
/
日本医疗器械审评审批机构(PMDA)
最新政策法规资讯
-
摩熵医药2026-06-17
-
摩熵医药2026-06-09
-
赛柏蓝2026-06-01
-
深蓝观2026-05-22
-
赛柏蓝2026-04-24
-
摩熵医械2026-01-28
-
摩熵医械2026-01-13
-
摩熵医械2025-12-19
-
赛柏蓝2025-12-12
-
摩熵医械2025-11-28
热门政策标签
医药市场洞察中心
医药市场销售数据分析 · 智能洞察 · 竞争格局监测
-
医药市场销售数据分析 · 医院、实体药店、网上药店
-
市场竞争格局分析(靶点、药品类型、ATC大类)
市场动态
市场报告
政策法规
-
2026-08-31
-
2026-08-30
-
摩熵咨询 35 45
-
摩熵咨询 28 45
-
颁布机构：国家市场监督管理总局 2026-08-10
-
颁布机构：国家市场监督管理总局 2026-05-29
最新其他政策
-
关于公开征求《全身型重症肌无力治疗药物临床试验技术指导原则（征求意见稿）》意见的通知
2026-08-28
-
关于做好全国第四批中成药采购联盟等批次中选结果执行工作的通知
2026-08-27
-
做好国家组织冠脉支架集中带量采购第二轮接续采购结果执行工作
2026-08-27
-
进一步优化药品和医用耗材集中带量采购管理工作
2026-08-26
-
关于做好长期护理保险支付管理工作的指导意见
2026-08-26
-
关于规范整合口腔等4类医疗服务价格项目的通知
2026-08-26
-
关于规范医疗机构特殊医学用途配方食品使用的指导意见
2026-08-26
-
非处方药转换保和颗粒、妇炎净片、五子衍宗颗粒和散痛舒分散片（含2个规格）的公示
2026-08-26
-
“医保病理云索引”编码规范
2026-08-25
-
关于进一步做好全区药品经营审批管理有关工作的通知
2026-08-25
-
关于公开发布第六批智能监管“两库”规则和知识点的公告
2026-08-25
-
关于印发“十五五”时期三级医院对口帮扶县级医院工作方案的通知
2026-08-25
-
非处方药转换调经活血胶囊、复方金钱草清热颗粒和排毒养颜片的公示
2026-08-25
-
做好“国家组织冠脉支架集中带量采购”第二轮接续采购中选结果执行有关工作
2026-08-24
-
进一步深化“六个拓展” 做实家庭医生签约服务若干措施
2026-08-24
全球药物研发中心
全球研发数据与行业前沿情报
研发动态
相关报告
政策法规
-
2026-08-30
-
2026-08-30
-
2026-08-30
-
摩熵咨询 20 8
-
摩熵咨询 34 36
-
摩熵咨询 20 5
-
颁布机构：四川省经济和信息化厅、中共四川省委军民融合发展委员会办公室、四川省教育厅、四川省科学技术厅、四川省人力资源和社会保障厅、四川省卫生健康委员会、四川省医疗保障局、四川省中医药管理局、四川省药品监督管理局 2026-08-04
-
颁布机构：国家医保局 2026-07-31
-
颁布机构：国家药品审评中心（CDE） 2026-07-24
同部门最新其他政策
-
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
2020-10-30
-
Procedures for Developing Post-marketing Study Plan
2019-01-23
-
Confirmation, etc. of the status of pre-approval GMP compliance inspection for new drugs
2017-09-19
-
Submission Documents for Application of Drug Compliance Inspection
2017-09-15
-
New Application Procedure for GMP Certification between the European Union and Japan
2013-07-17
-
Press Release: Exemption of the EU's regulatory control applicable to APIs exported from Japan to the European Union
2013-06-06
-
Q & A
2010-10-21
-
New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law
2009-11-04
-
Issuance of Certificates for Medical Devices for Export
2005-10-03
-
Explanation of Application for Accreditation of Foreign Manufacturers
2005-04-01
-
Category of Accreditation of Foreign Manufacturers
2005-04-01
-
Master File System for Drug Substances, etc.
2005-02-10
-
Q&A on the Master File (MF) System, Part I
2005-02-10
-
Q&A on the Master File (MF) System, Part II
2005-02-10
同地域最新其他政策
-
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
2020-10-30
-
Procedures for Developing Post-marketing Study Plan
2019-01-23
-
Confirmation, etc. of the status of pre-approval GMP compliance inspection for new drugs
2017-09-19
-
Submission Documents for Application of Drug Compliance Inspection
2017-09-15
-
New Application Procedure for GMP Certification between the European Union and Japan
2013-07-17
-
Press Release: Exemption of the EU's regulatory control applicable to APIs exported from Japan to the European Union
2013-06-06
-
Q & A
2010-10-21
-
New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law
2009-11-04
-
Issuance of Certificates for Medical Devices for Export
2005-10-03
-
Explanation of Application for Accreditation of Foreign Manufacturers
2005-04-01
-
Category of Accreditation of Foreign Manufacturers
2005-04-01
-
Master File System for Drug Substances, etc.
2005-02-10
-
Q&A on the Master File (MF) System, Part I
2005-02-10
-
Q&A on the Master File (MF) System, Part II
2005-02-10