ICH releases reflection paper on standardizing generic drugs

By PharmaCompass

2019-02-14

Impressions: 137 Article

The International Council on Harmonization (ICH) released a reflection paper last week with an aim to harmonize the scientific and technical standards for generic drugs across borders.

The paper outlines recommendations to develop a series of ICH guidelines on standards for demonstrating equivalence (e.g., bioequivalence) for non-complex dosage forms and more complex dosage forms and products. To accomplish this work, the ICH has proposed to establish a generic drug discussion group to assist in assessing the feasibility of harmonization of standards for generic drugs and to prioritize work areas.

“At present, a lack of harmonized standards reduces the number of potential markets in which data and information submitted in support of a generic drug marketing application can be used by a developer to support marketing authorization in another jurisdiction,” the paper says. “This can lead to monopolies or limited sources of drugs in those markets in which approval is not sought due to the additional development burdens.”

The push for harmonization comes as the US Food and Drug Administration (FDA) recently noted a disconnect between countries in terms of which generics are available.

Harmonization may allow generic developers to use their data and meet multiple jurisdictions’ regulatory requirements for marketing authorization. Harmonization could also increase the size of the generic drug markets and attract more competition, which would mean lower costs and expanded patient access in jurisdictions in which developers otherwise may have decided not to pursue, the paper adds.

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