Thursday, 10 January 2019

FDA aims to harmonize the global scientific and technical standards for generic drugs


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.



See: https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm623665.htm

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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