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Home » EU, Japan Expand Mutual Recognition Agreement
EU, Japan Expand Mutual Recognition Agreement
July 24, 2018
The European Union and Japan are expanding the range of medicines for which they will mutually recognize GMP inspections.
The scope of a 2004 mutual recognition agreement on inspections will be expanded to cover sterile drugs, APIs for any drug covered in the agreement, along with certain biologics including immunologicals and vaccines.
Japan also recognized as equivalent all EU competent authorities for human medicines inspection.
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