EMA Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (浙江太美医疗科技股份有限公司高级医学专员 黄希瑶)
药物警戒实践指南GVP-module-5-risk-management-systems-rev-2_en.pdf,28 March 2017 EMA/838713/2011 Rev 2* Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2) Date for coming into effect of first version 2 July 201
对产品安全性的严格审查是一项持续的活动,反映在定期安全更新报告(PSUR)提交的数据中(参见GVP模块VII),其中RMP的提交可能或不需要。此外,还有两个特定的重要事件,即在完全首次上市许可申请后获得批准的产品,建议上市许可持有者应考虑是否需要审查安全问题清单以及计划和正在进行的药物警戒和风险最小化活动: -?(第一次...
Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.Product- or population-specific considerations The chapters on product- or population-specific considerations are currently under ...
Also, revision 1 of Module VII on periodic safety update reports was provided in its final version following public consultation launched on 25 April 2013. This revision included updates for consistency with the recently finalised ICH-E2C(R2) guideline and on the operations in the EU. Today, ...
V.B.5.3. RMP part II, module SII “Non-clinical part of the safety specification” ... 13 V.B.5.4. RMP part II, module SIII “Clinical trial exposure” ... 14 V.B.5.5. RMP part II, module SIV “Populations not studied in clinical trials” ... 14 V.B.5.6. RMP part II...
22 June 2012 EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration with Member States and 19 January 2012 submitted to ERMS FG Draft agreed by ERMS FG 24 January 2012 Draft...
2021年3月9日欧盟体系药物戒备协议修订草案2修订草案监视组织〔EU-POG〕 2021年3月23日执行主任通过的第二次修订草案作为最终决定 2021年3月28日修订2生效日期* 2021年3月31日注:申请首次上市授权申请的RMP和申请GVP Module V Rev 1的D121申请将被承受为期6个月,其他所有RMP申请〔包括在加速评估下的初始申请的...