US to continue international inspection cooperation, says Marks

Regulatory NewsRegulatory News | 09 September 2021 |  By 

Some of the US Food and Drug Administration’s (FDA’s) pandemic-related changes are likely here to stay, a top FDA official told Focus.
In the leadup to RAPS Convergence 2021, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke with Focus about how CBER’s pandemic pivot accelerated a trend toward global cooperation, and how the changes stand to benefit patients and industry going forward.
Business as usual came to a halt when borders closed and international travel became risky at best, and often impossible. However, FDA and other health authorities could not stop their oversight functions and needed to find a way forward, noted Marks.
“Clearly, it helped to be able to share inspection reports with trusted partners for whom we had appropriate confidentiality agreements…It also helped to able to talk with other regulators about things like safety signals.” Marks particularly called out such cooperative efforts in the vaccine authorization process, citing a “very robust global regulatory initiative” around vaccine safety.
“Moving forward, I think we’ll continue to see sharing of these inspectional reports – that was something that was underway before this, and I’m sure it will continue,” said Marks. “It is a way of streamlining what we do.”
This global collaboration on the safety of therapeutics is also here to stay, said Marks, noting the advantages of large, pooled datasets in detecting safety signals.
Marks will be headlining a CBER-focused Health Authority Forum at RAPS Convergence 2021 on Monday, 13 September at 3 pm EDT. Other sessions will feature leaders from Japan’s Pharmaceuticals and Medical Devices Agency as well as FDA’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research. Find all Convergence Health Authority Forums here.
RAPS 2021 Convergence Health Authority Forums


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