FDA asks peers to globalize generic drug development

FDA is calling on international regulatory authorities to develop harmonized guidelines on scientific and technical standards for generic drugs that would allow manufacturers to use the same data and applications to gain approval across multiple jurisdictions. The agency submitted its proposal to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

"Generic drug developers should be able to implement a single global drug development program and utilize common elements of applications to file for approval in multiple markets," FDA Commissioner Scott Gottlieb said in a blog post Thursday. "This would make it easier for developers that would otherwise only seek generic drug approval in one region to also seek approval in the United States, increasing competition in America."...