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.
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The US drug regulator may now rely on a total of 22 EU member states whose inspection results can replace its own inspections.
The US Food and Drug Administration can now rely on the results of GMP inspections from 20 EU member states after confirming that five more countries have been deemed suitable for inclusion in its mutual recognition agreement with the EU.
The European Medicines Agency says it is too early to speculate on when the EU will recognize the first US Food and Drug Administration inspection under the mutual recognition agreement signed last year.