FDA & EMA investigations show broadly aligned results

A study conducted by the US Food and Drug Administration and European Medicines Agency found that the agencies are identifying the same types of deficiencies in clinical investigations submitted in marketing authorization packages between 2009 and 2015.


The study compared GCP inspection findings for 31 marketing applications having the same trial data. It looked at deficiencies in four areas: protocol compliance, documentation, human subject protections, and conditions for the study drug.


The two regulators identified similar problems with respect to clinical investigator inspections and CRO inspections. They found protocol compliance problems at 22 of 25 clinical investigator sites, documentation deficiencies at 17 of 25 clinical investigator sites, and human subject protection violations at 11 of 19 clinical investigator sites.


The most common inspectional findings for clinical investigators were in the areas of protocol compliance and documentation.


The study's findings were summarised as follows: "GCP inspection findings from 49 common clinical investigator and sponsor/contract research firms’ inspections were equivalent.” The analysis backs up our current procedure of exchanging inspection reports and information between the two agencies for the purpose of planning GCP inspections.


The good news is our GCP courses are aligned with the GCP rules followed by both the FDA and EMA. Many clinical research companies and institutions use our courses to support and promote the ethical, efficient and cost-effective way of developing new medicine for patients.



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