This can be considered a real milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers (we reported) and should strengthen the EU-US relationship.
The new confidentiality commitment formally recognises that FDA's EU counterparts have the authority and demonstrated the ability to protect the relevant information. The sharing of full inspection reports is now possible, allowing regulators to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk.
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