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【更新提示】药政信息摘要2017.01
出自识林
2017-01-29
FDA小企业专题:FDA在仿制药使用者付费法案第二期中解决的小企业问题(01.29)
FDA SBIA: FDA Addresses Small Business Concerns in GDUFA II
孤儿药上市后指定程序 (01.27)
EMA Post-orphan medicinal product designation procedures
CFDA 药物临床试验的一般考虑指导原则(01.20)
CFDA 总局关于公布国家药品编码本位码数据的公告 (01.20)
FDA指南草案:证明与参照药品可互换性的考虑(01.18)
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
FDA指南草案:证明与参照药品可互换性的考虑(01.17)
Considerations in Demonstrating Interchangeability With a Reference Product DRAFT
FDA指南草案:符合FDA标签要求的医药产品沟通(01.17)
Medical Product Communications That Are Consistent With the FDA-Required Labeling Q&A
FDA定稿指南:药品滥用潜力的评估(01.17)
Assessment of Abuse Potential of Drugs
FDA小企业指南:医疗用气体容器密闭系统法规问答(01.17)
Medical Gas Container-Closure Rule Questions and Answers
企业参比制剂备案情况的信息公开(2016年5月20日至11月4日备案信息)(01.13)
FDA指南草案: 以ANDA形式递交的药品-器械组合产品的比对分析和相关比对使用人为因素研究(01.13)
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
FDA指南草案: ANDA提交中的参照的已获批药品(01.13)
Referencing Approved Drug Products in ANDA Submissions
FDA修订版1定稿指南:基于FD&C法案第503A节的使用待包装药物进行配药指南(01.13)
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
FDA修订版1定稿指南:基于FD&C法案第503B节的使用待包装药物进行配药指南(01.13)
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
FDA指南草案:关于180天专营期的问答(01.12)
180-Day Exclusivity Questions and Answers
FDA定稿指南:药房和外包设施重新包装特定人用药品指南(01.12)
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
FDA定稿指南:生物制品非专利名命名(01.12)
Nonproprietary Naming of Biological Products
FDA指南草案:生物制品在已获批生物制品许可申请(BLA)范围外的混合、稀释或重新包装(01.12)
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
FDA指南草案:临床研究中多个终点指导原则(01.12)
Nonproprietary Naming of Biological Products
FDA指南草案:阿司匹林非处方药物的标签关于心血管相关方面的推荐表述(01.11)
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery
FDA定稿指南:含对乙酰氨基酚非处方药的推荐警告和关于严重皮肤反应的标签声明(01.11)
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions
国医改办发〔2016〕4号 — 关于在公立医疗机构药品采购中推行 “两票制”的实施意见(试行)(01.11)
CFDA中成药通用名称命名技术指导原则(征求意见稿)(01.11)
CDE 已上市化学药品生产工艺变更研究技术指导原则(征求意见稿)(01.11)
基于风险的防止生产中的交叉污染和“共用设施中生产的不同药品使用风险识别设置基于健康的接触限度”—实施问答 (01.09)
Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’
CFDA 发布医疗器械生产企业质量控制与成品放行指南(01.04)
CFDA 《药品上市许可持有人制度试点方案》政策解读(三)(01.03)
国际GMP检查报告和措施:
【FDA警告信】宁波知心鸟保洁用品有限公司 (01.07)
EudraGMDP NCR不合规报告:巴西 ANTIBIOTICOS DO BRASIL LTDA (01.29)
EudraGMDP NCR不合规报告:西班牙 EURO FAR ALERGI, S. L. (01.29)
【FDA警告信】英国 Porton Biopharma Limited (01.25)
CFDA 药品飞行检查 山西旺龙药业集团有限公司(01.20)
【FDA警告信】苏州医药技术有限公司(01.18)
【FDA警告信】美国Horizon Pharmaceuticals(01.18)
【FDA警告信】日本Sato Yakuhin Kogyo Co., Ltd.(01.18)
EudraGMDP NCR不合规报告:丹麦 EuroPharma.DK ApS(01.07)
CFDA 药品飞行检查 安国市祁澳中药饮片有限公司(01.06)
CFDA 药品飞行检查 上海庆安药业集团宿州制药有限公司(01.06)
CFDA 药品飞行检查 湖北潜江制药股份有限公司(01.06)
【FDA 483】印度 Divi's Laboratories(01.02)
【FDA警告信】印度 Wockhardt(01.02)