US-EU Inspection Deal Hits Milestone As Batch Test Waiver Kicks In
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.
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Product pre-approval inspections, vaccines and plasma-derived products are on the discussion agenda as the US-EU mutual recognition agreement takes full effect.
There is now only one country left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.