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EU & FDA to Share Inspection Outcomes

A major cooperation milestone has been reached between the European Commission & the US FDA.

November 2017 sees a mutual recognition agreement drafted, enabling the recognition of inspections of manufacturing sites for human medicines conducted in their respective territories. This cooperation will aim to improve the use of available resources to safeguard quality and safety of medicines.

The agreement enables both the EU authorities and the FDA to make better use of their inspection resources and focus on sites of higher risk where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured.

European Medicines Agency

 

 

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