Comments
The European Medicines Agency (EMA) has started a review in connection with findings of alleged non-compliance with good clinical practice (GCP) at a facility owned by GVK Biosciences, a city-based Contract Research Organisation.
The European body’s action follows an inspection by the French medicines agency (ANSM) which raised concerns over study data used by GVK Bio to support the marketing authorisation applications of generic medicines.
“The review will cover nationally authorised medicines whose marketing authorisation applications included clinical data from studies conducted by GVK Biosciences Pvt Ltd, Hyderabad.
The review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission, under Article 31 of Directive 2001/83/EC,” a European drug regulator statement said.
When contacted GVK, a company official said that from May 19-23, a regulatory inspector from ANSM inspected their Hyderabad Clinical facility and the company has submitted necessary clarifications to the French authorities.
“Further, we were invited by the European authorities, GVK BIO met the European authorities in-person last week, presented the data and demonstrated how we have optimised our processes internally.
“We are in the resolution stage and hope to close the matter to their satisfaction at the earliest. We are expecting the closure (of the matter) by October 26,” the official said.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.