EU, US Commit To Sharing Full Inspection Reports To Supplement GMP Mutual Recognition
EU and US drug regulators have signed a new confidentiality commitment that allows both parties to exchange full medicine inspection reports with each other. This was not possible before.
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US FDA recognizes the drug regulatory authorities for eight of the European Union's 28 member states by a Nov. 1 deadline, triggering key provisions of the landmark mutual recognition agreement.
FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.
Reliance on each other’s good manufacturing practice reports should allow EU and US regulators to better focus their limited inspection resources on drug manufacturers in other countries around the world.