| 查看: 196 | 回复: 0 | |||
| 当前主题已经存档。 | |||
[交流]
GMP文件常见缩写
|
|||
|
ABPI Association of the British Pharmaceutical Industry ADR Adverse Drug Reaction AE Adverse Event AIM Active Ingredient Manufacturer ANDA Abbreviated New Drug Application ANOVA Analysis of Variance ASM: Active Substance Manufacturer ATC Anatomical Therapeutic Chemical ATX Animal Test Exemption Certificate BAN British Approved Name BIRA British Institute of Regulatory Affairs BNF British National Formulary BP British Pharmacopoeia C of A Certificate of Analysis C of S Certificate of Suitability CENTRE FOR DRUG EVALUATION (CDE) Centre for Pharmaceutical Administration (CPA) CMS Concerned Member State CMS每个成员国 COS Certificate of Suitability CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organisation CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical Document CTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Branch (DRB), Product Evaluation & Registration Division, CPA EDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会 EEA 欧洲经济地区 EGMA European Generics Medicine Association ELA Established Licence Application EMEA European Medicines Evaluation Agency EMEA （European Agency for the Evaluation of Medicinal Products） 欧洲联盟药品评价机构 EP European Pharmacopoeia EPAR European Public Assessment Reports ESRA European Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会 FDA FDA Food and Drug Administration final evaluation report (FER) free sale certificates (FSCs) GCP Good Clinical Practice GCP药品临床研究管理规范 GLP Good Laboratory Practice GLP 药品临床前安全性研究质量管理规范 GMP Good Manufacturing Practice GMP 药品生产质量管理规范 GSP药品销售管理规范 Health Sciences Authority (HSA) HSA’s Medicines Advisory Committee (MAC) IB Investigators Brochure ICH International Conference for Harmonisation IDMC Independent Data-Monitoring Committee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Name International Conference on Harmonisation (ICH) IPC In Process Control IRB Institutional Review Board LICENCE HOLDER MA Marketing Authorisation MAA Marketing Authorisation Application MAA上市申请 MAH Marketing Authorisation Holder MAH 销售许可持有者 MCA Medicines Control Agency MHW Ministry of Health and Welfare (Japan) MR Mutual Recognition MRA 美国与欧盟的互认协议 MRAs (Mutual Recognition Agreements) 互相認證同意 MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Substance NCE New Chemical Entity NDA New Drug Application new chemical entities (NCEs) new drug applications (NDAs) NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over The Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia PIL Patient Information Leaflet PL Product Licence POM Prescription Only Medicine PRODUCT OWNER PSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS相互认可另一成员国 RSD Relative Standard Deviation Rx Prescription Only SAE Serious Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP （STANDARD OPERATION PROCEDURE） 标准运作程序 SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC) Therapeutic Goods Administration (TGA) USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Products Committee |
回复此楼» 猜你喜欢
高温加热及反应瓶材质选型
已经有1人回复
-
【交流】钆塞酸二钠：肝胆 MRI 对比剂，纯度与杂质管控的探讨
已经有0人回复
-
药理学论文润色/翻译怎么收费?
已经有297人回复
-
【交流】换季有感｜夫西地酸杂质一条有意思的连锁降解反应链
已经有0人回复
-
求助
已经有0人回复
-
[质量控制 交流] 硼替佐米质控难点，和普通多肽 API 差异分享
已经有0人回复
-
利奈唑胺质控｜强制降解试验心得
已经有0人回复
-
富马酸比索洛尔杂质机理与制备难点探讨
已经有0人回复
-
【分享】福多司坦杂质降解反应｜QC 检验交流
已经有0人回复
-
【交流】地塞米松磷酸钠的几个化学反应以及有关物质质控心得
已经有0人回复
-
【质量控制交流】维生素 C 杂质研究分享，脱氢抗坏血酸质控要点
已经有0人回复
