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 Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.