Following the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to suspend the licences for some medicines licensed in the European Union (EU) that were based on clinical trials conducted at GVK Biosciences’ site in Hyderabad, India, Dr Samantha Atkinson, Deputy Director of MHRA’s inspection, enforcement and standards (IE&S) division said:

“This is a precautionary measure. There is no evidence to suggest that these medicines are not safe and effective and people should continue to take their medicines as prescribed.”

“This recommendation will now be considered by the European Commission and it will make the final decision as to whether the suspensions should be imposed. If the recommendation is adopted by the Commission, we will work with our colleagues at the Department of Health to ensure people have access to the medicines they need.”


Posted on the UK MHRA website on 23 January 2015