EMA: Updated Q&As on the Impact of the EU-US MRA
The EMA has published an updated Q&A on the impact of MRA between the EU and the US. Since last year, the US has confirmed the capability of 4 additional EU Member States for veterinary product inspections.
On 30 May 2023, following an assessment of the US FDA based on similar requirements to the one conducted for human medicines, the EU recognised the US FDA as equivalent for GMP inspections of veterinary products. At the same time the US FDA confirmed the capability of 16 EU Member States – Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Slovenia, Luxembourg, Netherlands, Poland, Portugal, and Spain. With these recognitions, the MRA became operational for veterinary products.
Between June 2023 and 7 August 2024 FDA confirmed the capability of Sweden, Latvia, Lithuania and Germany. The assessments of the remaining 7 EU Member States for inspections of manufacturers of veterinary products are on-going. In July 2024 European Commission and FDA have agreed to extend the timeline for the completion of the assessments till 31 January 2025.
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