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The decision came as a result of an inspection that raised concerns on how GVK carried out those studies at the Hyderabad site on behalf of marketing authorization holders.
EMA has recommended the suspension of a number of medicines, authorized in the EU, based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The decision came as a result of an inspection that raised concerns on how GVK carried out those studies at the Hyderabad site on behalf of marketing authorization holders. The list of medicines recommended for suspension can be found here.
EMA’s Committee for Medicinal Products for Human Use (CHMP) evaluated more than 1000 pharmaceutical forms and strengths studied at the GVK site in response to a request by the European Commission. More than 300 products were found to have sufficient supporting data from other sources and will remain on the EU market. For medicines that lacked data from other studies, the CHMP has recommended their suspension. Medicines considered to be critically important to patients, such as those with no alternative treatments, will remain available. There is no evidence of harm or lack of effectiveness associated with the studies conducted by GVK.
The inspection of GVK by the French medicines agency (ANSM) revealed data manipulations of electrocardiograms (ECGs) in some studies of generic medicines. It appeared that these manipulations took place for at least five years causing doubts on the reliability and integrity of data generated at that site.
EMA and national authorities work closely with international partners to ensure that studies underpinning marketing authorizations in the EU are carried out to the highest standards and that the companies involved comply fully with all aspects of good clinical practice (GCP). The CHMP’s recommendation will be sent to the European Commission for a legally binding decision. This decision will apply to all member states irrespective of whether or not they have taken interim measures to suspend medicines.