FDA, MHRA and WHO Guidances Shed Further Light on Data Integrity Concerns

Guidances issued between April and July 2016 by FDA, UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and the World Health Organization (WHO) are providing a stronger foundation for the industry/regulator dialogue around the world on where the current gaps are in industry’s oversight of data integrity (DI) and how those gaps should be filled.

The efforts by the three health authorities to better define their expectations for data integrity follow in the wake of a clear uptrend in their inspection findings of significant DI lapses across the industry, which have been manifesting in US FDA warning letters, EU non-compliance statements, and WHO notices of concern.

In turn, the causes of the shortfalls, and the pathways for industry and health authorities to address them and improve data reliability, have been getting front-burner attention from various industry and regulator working groups and at the conferences and forums where GMP compliance and quality system issues are in focus.

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