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Inspection Readiness: What's Next?

Written by Daniela Tatangelo | Oct 10, 2023 6:00:00 AM

ABSTRACT 

The impact of globalization and the COVID-19 pandemic on pharmaceutical inspections and audits cannot be overstated. These two elements alone have accelerated a monumental shift in the industry's regulatory framework, leading to more international cooperation and reliance on foreign competent authorities. The Mutual Recognition Agreement (MRA), a culmination of a push toward closer cooperation, played a key role during the pandemic, fostering collaboration between nations at such a critical time. The 2023 EMA programming document forecasts the next five years to be characterized by close ties within the scope of the MRA to promote inspection information exchange, as well as hybrid inspections and more collaborative programs by ICMRA as pilots are underway. This article examines the effects.