FDA launches global Generic Drug Cluster

Regulatory NewsRegulatory News | 14 June 2021 |  By 

In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug Administration is standing up a Generic Drug Cluster.
Described as “the first forum established for the world’s leading regulatory agencies to address generic drug development globally,” the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety of approaches. FDA announced the launch of the new body in a 14 June tweet from its FDA Drug Information Twitter account.
A primary goal of the Generic Drug Cluster will be to help international regulators reach a common understanding of requirements for generic approvals, and to share their current thinking on related topics as set forth in guidance documents promulgated by the individual regulatory bodies.
Also, the new body will be a “confidential forum for exchange of discussion on policies in development,” wrote FDA. The agency envisions that the scope of confidential discussions will include drafts of industry guidance, as well as the scientific underpinnings for generics policy.
The forum’s work will also include looking at both general scientific review issues and those that pertain to individual products or classes of products. When possible, forum members will seek alignment in scientific approaches taken.
Finally, the forum will serve as “a global safety net for generic drugs,” tracking and acting on long-term safety issues by sharing otherwise confidential safety reports among member regulatory bodies.
Today’s announcement comes after Sarah Ibrahim, FDA’s associate director of Global Generic Drug Affairs, gave an overview of global efforts to increase engagement and harmonization around matters related to generic drug development in a May 2021 presentation.
In the presentation, Ibrahim referenced the recent International Council on Harmonisation (ICH) Reflection Paper that proposed developing a series of standards for demonstrating bioequivalence for both non-complex and complex dosage forms of generic medicines. (RELATED: ICH seeks to harmonize generic drug standards, Regulatory Focus 06 February 2019)
A global generics approach that fosters increased harmonization would lessen the regulatory burden on generics developers while increasing choices and simultaneously strengthening safety and efficacy guardrails for patients in participating countries, Ibrahim pointed out.
In terms of complex generics development, even a “well-resourced and skilled” regulator such as FDA still “sees the benefit of cooperation and collaboration with regulatory authorities to avoid effort duplication and improve decision-making, while encouraging generic competition for complex products,” said Ibrahim. She acknowledged that socioeconomic, cultural and political differences among member countries, as well as differing regulatory approaches and policies, present potential hurdles to regulator alignment.
Still, she said, “Our opportunity for harmonization is now. And moving towards common standards for global development for generics can improve access to generic products, with substantial healthcare savings.”


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