A proposed new standard that defines the criteria for inclusion and exclusion of drugs in the list used as reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil’s national regulatory agency, Anvisa, on June 14. A key provision of this proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the drug in order to conduct the bioequivalence testing needed for the registration of a generic version of the reference product. Generic companies now run into problems obtaining such drugs that are restricted to hospital use or are distributed only in specific programs.
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