IGMPI India



GVK Biosciences under the scanner of European Medicines Agency

Findings related with noncompliance to GCP following an inspection by French Medicines Agency have led EMA to review GVK Biosciences pertaining to the findings raised. The marketing authorization applications of nationalized medicines which included clinical data of the studies conducted by GVK Biosciences Hyderabad will be reviewed by EMA.

Inspection by French regulatory was conducted from May 19-23rd in the clinical facility and as per the statement of a GVK company official the necessary clarifications have been submitted to the French authorities.
A meeting was held between GVK bio and European authorities where GVK Bio presented their data and explained how the processes are optimized internally but resolution to the issues raised is still awaited.