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.
Downloads
Related news and resources
IFPMA-INTERFARMA-FIFARMA statement on the Rio de Janeiro Declaration of the G20 Health Ministers
The innovative pharmaceutical industry, represented by IFPMA, INTERFARMA and FIFARMA reiterates its commitment to the G20 health priorities, reaffirmed in the Rio de Janeiro Declaration.
Read moreWHO EMRO RC71: Regional flagship initiative 1: Expanding equitable access to medical products
On 14 October 2024 in Doha, Qatar, IFPMA delivered a statement at the 71st session of the WHO EMRO Regional Committee on the Regional flagship initiative 1: Expanding equitable access to medical products.
Read moreThe Value of Reference Agency Assessment Reports in Enabling Regulatory Reliance
Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was reviewed by the reference NRA, provides a rationale for decision making and promotes confidence and trust. The Centre for Innovation in Regulatory Science (CIRS) has published...
Read more