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FDA proposing to harmonise standards for generic drug approval.

Scott Gottlieb, head of the FDA is advancing the idea of streamlining drug approvals via regulatory convergence to enable a single global approval for multiple markets. Considering it, this idea has a lot of attractions - it would enable pharma companies who develop generics to secure access to markets beyond their local ones. 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, historica