This 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.
This 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.
In view of a growing complexity of product lifecycle management, industry puts forward perspectives to support the harmonization of regulatory requirements. These are intended to facilitate efficient regulatory review and approval to support timely implementation of changes and product improvements, leading to more resilient supply chains.