How far can Generics manufacturers rely on the Originators
trial data in the ASEAN region?
Introduction
Data exclusivity is generally understood to mean generic drug
makers may not rely on data submitted by the originator to obtain
approval for the same drug. In other words, manufacturers will have
to submit their own trial data for marketing authorization, even if
there is already a prior approval for the same drug and
indication.
In a sense, the originator clinical trial data held by the drug
agency is not freely available to third parties. However, the
obligation to keep trial data confidential should not be confused
with the concept of data exclusivity.
In the absence of data exclusivity, the generic drug
manufacturer will be free to request that the drug agency rely on
the originator data to grant approval for the same drug. Such can
be done without the generic maker having access to the data since
it is the drug agency that is asked to refer to such
