This is an update to the letter from the France's ANSM to the MAHs dated 23rd October 2014 regarding the concerns raised by ANSM over the check-out ECG's conducted at GVK BIO's Clinical facility, Hyderabad. GVK BIO had addressed these concerns and had submitted independent Cardiology assessments of the ECGs indicating that the ECGs can belong to multiple volunteers and it's difficult to conclude that ECGs belonged to the same volunteer. We also provided evidence that all key activities such as dosing, blood sampling and processing were adequately controlled, supervised and staff were qualified to do the work. GVK BIO also strengthened its operating procedures around taking ECGs and these were accepted by the authorities.
We are disappointed that despite providing detailed clarifications, unfortunately CHMP (Committee for Medicinal products for Human use) has concluded that though the "check-out" ECGs may have no direct relevance to the quality of the testing of drugs, the fact that the same employees were involved in other critical activities, left an element of doubt on the Bio-equivalence results. Hence authorities have concluded that BE studies conducted at our Hyderabad clinic are not sufficient to support Marketing Authorisation Holders (MAHs) for the products approved. We expect the Marketing Authorisation Holders will need to repeat the studies in the next 12-15 months.
We at GVK BIO believe that the studies conducted are in accordance with the GCP guidelines while we honour the conclusion made by CHMP and are working with our clinical development customers to provide new data that meets all regulatory requirements.
If you have any questions, please feel free to reach out to us.