GVK BIO is respectful of the EMA decision taken in the interest of human health.
The EMA recommendation is based on the French Agency's report that concluded duplication of check-out ECG recordings of trial participants in 9 studies. The EMA, on basis of a "doubt", has extrapolated the findings to ALL studies conducted at GVK BIO's Hyderabad Clinical facility. We believe that the action is unprecedented and highly disproportional given the following :
The French Agency states that "the electrocardiograms (ECGs) inspected are not essential given the demonstration of bioequivalence, they can only track the health of the person in clinical trials." The French Agency's recommendation has been made as a 'precautionary' measure.
The French Agency also states "the observations made during the inspection of GVK BIO's clinical activities in Hyderabad should not be extrapolated to other trial-related activities at the same site (bioanalytical, pharmacokinetic and statistical activities) or to their other site in Ahmedabad, which are not directly affected by these observations"
The EMA states "Nothing/no evidence to date has established a proven risk to human health or lack of effectiveness of the products concerned"
GVK BIO is working closely with its customers to ensure an appropriate and quick resolution to these issues.