The ANSM is initiating a suspension procedure, as of December 18, of 25 drugs marketed in France.
An inspection by the ANSM of a site of the company GVK Bio, which carries out clinical trials including bioequivalence trials in India, has revealed irregularities in documents associated with these trials on which the MA (marketing authorisation) of several drugs is based.
The ANSM has decided, as a precautionary measure, to suspend the MAs of 25 marketed generic drugs.
The European authorities have been seized by France and, pending their final decision, Germany, Belgium and Luxembourg have also decided to suspend the marketing authorisations of the medicines concerned.
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