而欧盟GVP Module VIII里面没有相关论述,因此在做药物申报注册时需要根据申报对象的不同制定不同的研发策略。 如果您的企业需要做中美双报,则务必额外关注这一点。 活动规则 本活动截止日期:2021年12月2日即日起,参与GVP每日解读答题活动每答对一题→可积1分每1积分→等值于5枚太美学习币每月第三个周二都将公布...
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...
Guideline on Good Pharmacovigilance Practices (GVP). Module VIII - Post-authorisation safety studies. [consultado el 6 de mayo de 2013] Disponible en http://www.ema.europa.eu/ema/index.jsp? curl = pages/regulation/document_listing/document_listing_000345.jsp....
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 ...
Module VIII Revision 1 and its Addendum Revision 1 as well as in Annex II – Template for the PSUR Cover Page Revision 1 were published on 25 April 2013. On 7 June 2013, the draft revision 1 of Module VI on the management and reporting of adverse reactions was released for public ...
药物戒备方案的研究应根据相应的立法进展设计和实施,并在GVP模块VIII中提出建议。只有在研究纳入药物戒备方案并且主管部门已经要求提交方案时,研究方案才可以纳入RMP更新评估。在RMP附件3 - C局部〔或电子链接或eCTD档案其他局部中包含的协议的参考文献〕中应提供审查和批准的药物戒备方案研究协议。其他3类研究议定书也...
药物警戒计划的研究应根据相应的立法进行设计和实施,并在GVP模块VIII中提出建议。只有在研究纳入药物警戒计划并且主管部门已经要求提交方案时,研究方案才可以纳入RMP更新评估。在RMP附件3 - C部分(或电子链接或eCTD档案其他部分中包含的协议的参考文献)中应提供审查和批准的药物警戒计划研究协议。其他3类研究议定书也...