French Drug Agency To Define Generics
The French Drug Agency is to determine what a generic drug or "copy of an original product" is, as part of the government's generic specialties legislation (Marketletter October 21).
A drug will be regarded as a "generic specialty" if it is included in a list drawn up by the Agency's director-general, says a preliminary text to be sent to the State Council. Each list, published in the Official Journal, will include drugs classified by generic grouping, carrying a specialty of reference ie the original product.
The Agency also indicates that under certain conditions, companies developing generics will be exempted from conducting bioequivalence studies.
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