The National Medicines Agency – suspended the marketing of 11 presentations of six generic medicines following a decision taken at the European level. The results of a study conducted by a company located in India are problematic. Alternatives to discontinued products are available in the market, improving regulation.
In newsletterThe decision follows an arbitration procedure launched in January this year, Inform explains, “requesting the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to evaluate concerns regarding doubts over marketing authorizations (AIM). About data integrity in studies conducted by Synchron Research Services, located in India.
The panel reviewed the available data and various information provided by the MA holders and “considered that Synergy Research Services did not provide any new information that would change the existing reasons for the jury’s view”. Due to this, the sale of these products has been stopped.
In the same note he issued siteoh Intellectual It clarifies that “there is no evidence of harm or lack of efficacy of any of the drugs included in this practice.” “However, the drugs were suspended until new, more reliable studies were presented,” he says.
“Alternatives are available, so patients taking the medications identified below can contact their doctor or pharmacist for more information,” he adds.
The activity included 11 presentations of six drugs marketed for the treatment of various ailments. There is an antibiotic, an antiretroviral, one to treat arthritis symptoms, another for flu symptoms, one for type 2 diabetes and one for cholesterol.
Regarding the latter, Inform determined the “immediate collection” of certain volumes, considering that only those are covered by the European Agency’s determination.
The India-headquartered company was responsible for bioequivalence studies, which are required to assess whether a generic medicine contains the same amount of active ingredient as a specific active ingredient. According to the information available in site gives European Medicines AgencyTo reverse this suspension, laboratories responsible for commercialization must present new studies demonstrating bioequivalence.
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