FDA proposes harmonization of global standards for generic drugs

By PharmaCompass

2018-10-25

Impressions: 117 Article

Last week, the FDA said it is putting forth a proposal to the International Council on Harmonization (ICH) to better harmonize scientific and technical standards for generic drugs.

The FDA proposal seeks to allow generic drug developers to implement a single global drug development program, which will allow for simultaneous approvals in multiple markets.

“The ultimate goal of this global harmonization of scientific and technical requirements would be the attainment of a single global generic drug development program that can support simultaneous regulatory filings across multiple markets. Harmonization of these requirements is foundational to achieving a future goal of enabling global approval for high quality generic drugs,” FDA commissioner Scott Gottlieb said in a statement.

More specifically, FDA is proposing that ICH develop a series of guidelines on standards for demonstrating bioequivalence for both non-complex and complex dosage forms, and drug products. FDA expects that ICH will review FDA’s proposal and that the ICH Assembly will endorse the proposal at its next meeting in November 2018.

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