IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18


Inside this issue


Portugal joins EU-US MRA for inspections

Portugal has become the 15th EU member state that the US Food and Drug Administration (FDA) recognises as being able to replace its own inspections, reports the European Medicines Agency (EMA).

The decision last month comes after an FDA assessment under the banner of the mutual recognition agreement (MRA) between EU and the US to recognise inspections of manufacturing sites for human medicines conducted in their respective territories.

Plans for the MRA to be operational in all EU member states by 15 July 2019 are “on track”, says the EMA.




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