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US, EU Hit Inspection Deal Milestone; Batch Test Waiver Kicks In

 
• By Neena Brizmohun

After 20 years in the making, the landmark GMP inspection MRA between the US and the EU is finally fully implemented. In addition, a batch test waiver has started to apply under the deal.

EU - USA
The US-EU MRA is now fully implemented. • Source: Shutterstock

EU and US regulators have now fully implemented the mutual recognition agreement (MRA) that allows them to rely on each other’s manufacturing inspection results for medicines in their own territories, after Slovakia became the final country to be cleared to join the initiative.

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