Inspection Data Reveals US/EU Mutual Recognition Agreement's Impact On China and India
The agreement reached in the early days of the Trump administration has been putting China and India drug manufacturing in the crosshairs of the world’s leading pharmaceutical inspectorates.
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Frances Zipp, president and CEO of Lachman Consultant Services, Inc, in an interview with Scrip, emphasizes the importance of the ‘cultural element’ and top management engagement in addressing compliance issues, including those pertaining to data integrity, at Indian firms.
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.
As US FDA sets its FY 2018 inspection priorities, it is considering whether there are recent or upcoming inspections by inspectorates in eight European countries recognized under a US/EU mutual recognition agreement that it could rely on instead, agency official says. Over time, FDA could rely more on EU inspection priorities.