EMA recommends suspending medicines over flawed studies
A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.
Upon the request of the European Commission (E.C.), EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site. For over 300 of them, sufficient supporting data from other sources were available; these will therefore remain on the market in the E.U. as EMA is satisfied with the available data.
For medicines that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.
The decision on whether a medicine is critical for patients lies with the national authorities of E.U. member states depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.
The inspection of GVK that led to the CHMP’s recommendation was carried out by the French medicines agency (ANSM). The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines. These manipulations appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site.
EMA and national authorities work closely with international partners to ensure that studies underpinning marketing authorizations in the E.U. 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 E.C. 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.