FDA has
submitted a proposal to ICH recommending the development of internationally
harmonized guidelines on scientific and technical standards for generic drugs.
ICH
is the global venue for harmonization of standards for pharmaceutical products,
including both new drugs and generic drugs. Although many existing ICH
guidelines are
applicable
to generic drugs, historically ICH has focused on standards for new drugs. As a
result, there are areas specific to generic drugs where harmonized guidance is
lacking.
FDA
envisages that harmonization of scientific and technical standards can
potentially bring important benefits. These include allowing developers to use
data they develop in support of a generic drug in one region to support
approval in other regions.
Plus
increasing consistency in the quality of generic medicines globally by
implementing common standards that simultaneously meet the requirements of multiple
regulatory authorities; and, increasing the effectiveness of regulatory oversight
(and reducing costs) by providing regulators more opportunities for information
sharing with counterparts in sister agencies.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
