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US Yes To Two More Countries Under EU Inspections Deal

Executive Summary

The US drug regulator may now rely on a total of 22 EU member states whose inspection results can replace its own inspections.

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Two More Member States Join US-EU Inspections Deal

The number of European countries whose drug manufacturing site inspections the US regulator can rely on in place of its own inspections has grown.

EMA Reports Sharp Reduction In EU GMP Inspections Last Year

EU health authorities inspected fewer drug manufacturing facilities under Europe’s centralized procedure in 2017 thanks to last year’s US/EU mutual recognition agreement, according to a 2017 annual report from the European Medicines Agency. They also found fewer GMP problems at the facilities they did inspect.

New EU Filings

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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