我们可以看到有过FDA现场核查或远程监管评估(RRAs)的国内GCP机构越来越多,通过EMA核查的GCP机构还不常见。 2023年,浙江省肿瘤医院共接受三次浙江省药品检查管理局日常监督检查、五次国家药品监督管理局食品药品审核查验中心现场核查、两个项目FDA核查、两个项目EMA核查,均顺利通过,实现了临床研究数量和质量的双提升。 ...
Good Clinical Practice Inspectors Working Group 2010 Adopted by the GCP IWG on 20 June 2012 The publication of this report has been delayed due to the migration of inspection data to our new database and the creation of our reporting tool to retrieve the statistics included in this report.
The EU legal framework requires that the sponsor of a clinical trial and the investigator ensure that the clinical trial is conducted in accordance to the protocol and with the principles of GCP. Furthermore, the legislation also defines the process of GCP inspection by a competent authority and ...
常见的GCP违背的例子包括:合同状态(statusof contracts),任务分工(distribution of delegated tasks),适用标准(standards tobe followed),稽查和视察相关(audits and inspections),严重违背相关(serious breaches),方案依从性(compliance with the protocol),输出(output)和豁免(exemptions). 合同状态(status of contracts) ...
The EU legal framework requires that the sponsor of a clinical trial and the investigator ensure that the clinical trial is conducted in accordance to the protocol and with the principles of GCP. Furthermore, the legislation also defines the process of GCP inspection by a competent authority and...
•Legislative developments: tomonitor new legislation, to assess and advise on potential impact on GMP, GDP,inspections or inspection-related activities. Particular attention will begiven to: • 立法开展:监测新法,评估其对GMP、GDP、检查或检查相关活动...
GCP IWG/CTFG Reflection paper on risk based quality management OECD Draft Recommendation on risk based approach endorsed – work on final text in progress FDA Draft guidance on monitoring EU GCP IWG / CHMP draft "Points to consider on GCP inspection findings and the benefit-risk balance" EU ...
Reflection Paper on advice to Applicants/Sponsors/CROs of Bioequivalence Studies 222 EMEA/INS/GCP/468975/2007关于生物等效性研究中申请者/赞助商/合作研究机构的建议的反馈文件, EMEA/INS/GCP/468975/2007 Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug...
(EMA/INS/GCP/532137/2010). Page 3/22 Non-clinical (pharmaco-toxicological) studies submitted in a marketing authorisation application shall be carried out in conformity with the provisions related to Good Laboratory Practice, Directive 2004/10/EC on the harmonisation of laws, regulations and ...
关于外用制剂关键质量属性的控制,本号已推出 指南4 和USP<3>;本文推出 EMA 关于 “外用制剂质量和等效性”指南,其中涉及的内容包括:外用制剂质量(描述与组成、产品开发、控制策略、稳定性)、等效性、批准后变更、IVRT、IVPT、角质层取样(胶带剥离)等 。言归正传,下文正式介绍 EMA 指南:Draft guideline on ...