Regulatory agilities applied to vaccines during the COVID-19 pandemic and recommendations for the future
During the COVID-19 pandemic, National Regulatory Authorities (NRAs) and the biopharmaceutical industry applied a variety of regulatory agilities to accelerate the development, evaluation, authorization, and supply of COVID-19 vaccines. These agilities were a key factor in enabling rapid patient access to vaccines.
Experience from the pandemic and the use of regulatory agilities offers valuable insights on how regulatory systems may be adapted to further support innovation and timely patient access to vaccines at all times, not just during emergencies.
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.
Related news and resources
How we are contributing to global pharmaceutical standards
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 more
Lessons from regulatory agilities during the COVID-19 pandemic: views from members of National Regulatory Authorities
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.
Read more
Industry perspectives on implementation of Quality Overall Summary-Product Dossier (QOS-PD) and Quality Information Summary (QIS) for innovative medicinal products
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.
Read more