IFPMA关于处理上市后变更的观点

beiwei5du · 发表于 2017-10-17 17:55:32

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本帖最后由 beiwei5du 于 2017-10-17 17:56 编辑

IFPMA position paper on the handling of post-approval changes to marketing authorizations（2016.11）
希望讨论！

beiwei5du · 发表于 2017-10-17 19:01:09

IFPMA的几点建议汇总
1、Consistent, risk-based, tiered variations systems for quality changes that include regulatory mechanisms and tools and use of an effective pharmaceutical quality system to facilitate product lifecycle management and a reduction in the post approval change burden for NRAs and industry;
2、Expedited approval of certain variations that are of significant benefit to patients, e.g. to prevent/alleviate drug shortages or improve safety;
3、 Clear and transparent regulatory assessment timelines and adherence by NRAs;
4、 Transparency, consistency and predictability in regulatory outcomes and decision making;
5、The development of closer harmonization and specialization of NRAs, where possible, leading to reliance and potential mutual recognition; and
6、Enhanced use of electronic means for timely access to updated product safety information.

套路 · 发表于 2018-1-4 13:56:23

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大龙12 · 发表于 2020-7-23 18:15:11

套路发表于 2018-1-4 13:56
谢谢楼主大公无私分享！

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感谢分享！！

小金库 · 发表于 2022-7-14 22:02:12

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