The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb.
The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets simultaneously.
Because global standards for basic components of generic drug development are not in place, companies with limited resources are sometimes forced to apply for approval in a limited number of markets, the FDA noted.
“In some markets, a generic drug developer may not seek approval for a generic drug at all. These decisions can limit competition, increase prices, and increase the risk of shortages,” Gottlieb said in prepared remarks.
“We want to advance the international harmonization of scientific and technical standards for generic drug development,” he explained. “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. And it would also make it easier for developers that would otherwise only seek generic drug approval in the U.S. market to gain access to other markets.”
The FDA reportedly proposed that ICH create guidelines on standards for demonstrating equivalence for non-complex dosage forms and more complex dosage forms and drugs products.
“These activities include pursuing opportunities like a harmonized bioequivalence study design that could be expanded to include additional study arms to accommodate more than one reference product for bridging purposes,” Gottlieb said.
The ICH Assembly will be invited to endorse the agency’s proposal at a meeting in November, according to the FDA.