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The International Generic Drug Regulators Programme (IGDRP) was created to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads, globalisation and complexity of scientific issues.
The availability of quality generic drugs plays an increasingly important role in helping to address rising health care costs and in promoting access to essential medicines worldwide. This, however, has led to significant pressures on medicines regulatory authorities charged with the review and approval of these products.
In addition to an increased workload associated with the growing number of generic drug applications, authorities must now also contend with more sophisticated generic drug products and complex global production and distribution chains.
Initially operating as a pilot from 2011-2014, the strong commitment of participating regulators, as well as the progress achieved during the pilot phase have demonstrated value in continuing this work. This website contains latest updates on key IGDRP initiatives.
Meaning:
The International Generic Drug Regulators Programme
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