Lessons from regulatory agilities during the COVID-19 pandemic: views from members of National Regulatory Authorities
To address the COVID-19 pandemic, regulatory agilities were allowed and utilized by National Regulatory Authorities (NRAs) in an unprecedented manner to accelerate the development, assessment, and approval of medicines and vaccines. Since 2021,
the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has been exploring common regulatory agilities utilized during the early phases of the pandemic alongside related experiences, challenges, and lessons learned, to explore how regulatory processes might be further enhanced in the future
in both non-emergency and emergency situations.
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. Insights were collected via interviews with members of NRAs from Brazil, Ghana, and Japan, thus gathering views from different regions. Understanding the views of NRA members on regulatory agilities can help to develop realistic approaches to strengthen both non-emergency and emergency regulatory frameworks moving forward. The insights included in this report reflect the personal views of the individuals interviewed and are not representative of the position of any specific NRA.