The evolving global pharmaceutical regulatory environment and the increasing interest of new countries in joining the ICH highlights the importance of maintaining consistent interpretation and implementation of ICH guidelines among industry and regulatory authorities worldwide. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), along with other ICH Members and Observers, has an important role...
Read moreThis position paper outlines some key regulatory agilities implemented in areas such as research and development, regulatory evaluations, authorizations, and post-approval changes (PACs) and labelling. Key learnings and recommendations to enhance regulatory frameworks in the future are also included.
Read moreThis report aims to explore the perspective of members of NRAs on the use of regulatory agilities which emerged during the COVID-19 pandemic and describe lessons learnt from this experience.
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