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Medicines considered critically important for patients to remain available.
EMA remains firm on its recommendation to suspend a number of medicines authorized in the European Union, based on clinical studies carried out at GVK Biosciences in Hyderabad, India. In January 2015, the agency issued a recommendation for approximately 700 medicines to be suspended following concerns about flawed studies found at the CRO’s Hyderabad site.
EMA has re-examined the case upon the request of marketing authorization holders for seven of the medicines concerned. The outcome of the re-examination remains the same, with EMA adopting its original recommendation.
In January, EMA reported that an inspection of GVK’s Hyderabad site by the French medicines agency (ANSM) revealed data manipulations of electrocardiograms (ECGs) in several clinical studies of generic medicines, which appeared to have taken place over a period of at least five years. Concerns were raised over the systematic nature, the extended period of time during which the studies took place, and the number of members of staff involved, which consequently caused doubts on the integrity of the conduct of trials at the site as well as the reliability of data generated.
Following the re-examination, EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the reliability of the clinical studies remains questionable, and therefore, the agency is standing by its earlier recommendation to suspend these medicines, for which no supporting data from other studies were available.
One medicine, however, has been removed from the list of medicines recommended for suspension. Bivolet (nebivolol) 5 mg tablets (marketing authorization holder: Neo Balkanika EOOD) is no longer recommended for suspended, according to EMA. An updated list of medicines for which EMA recommends suspension is available on EMA’s website. For approximatley 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU.
According the CHMP, there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. EMA says that some critically important medicines may remain on the market in some countries if alternatives cannot meet patients’ needs. The national authorities of EU member states will decide on whether or not a medicine is considered critical, depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.
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. The CHMP’s recommendation will now 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.