Global Generic Drug Affairs

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M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance

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FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements. The role of the Global Generic Drug Affairs Team is to lead, coordinate, and manage OGD’s international activities in collaboration with FDA Centers and Offices to advance the overall mission of OGD and FDA.

OGD’s International Activities and Engagements

Generic Drug Cluster Adds Member Agency

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The FDA led forum, the Generic Drug Cluster, established for the world’s leading regulatory agencies to address generic drug development globally, has added a new regulatory agency to its roster– Australia’s Therapeutic Goods Administration (TGA). This makes a total of seven regulatory agencies participating in the Cluster. The Generic Drug Cluster aims to increase scientific alignment among leading generic drug regulatory agencies by fulfilling the following objectives:

Offering a confidential forum for exchange of discussion on policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies. The regulatory agencies included in the cluster have Confidentiality Commitments and the Generic Drug Cluster does not release information regarding the topics discussed in the cluster. Additionally, no guidance information is released outside the scope of the confidentiality commitment governing the cluster.
Achieving a common understanding of each agency’s regulatory requirements for approval and current thinking on topics related to generic drug development through information sharing on approval requirements and recommendations conveyed in guidance documents.
Provision of a forum for a discussion of general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation whenever possible.
Addressing long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports.

The OGD Global Generic Drug Affairs team collaborates with strategic partners within and outside FDA to establish internationally-focused programs that promote and protect the American public health. In collaboration with industry, international regulatory agencies, the scientific community, and the public, OGD’s global affairs activities encompass harmonization on scientific and technical recommendations for generic drugs under FDA’s Center for Drug Evaluation and Research (CDER) international harmonization initiatives, regulatory strengthening and reliance, partnerships and information sharing, and setting international standards. Recent collaborations include:

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms - On January 31, 2023, FDA published a draft guidance for industry, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides recommendations for conducting bioequivalence (BE) studies during development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. Comments about this draft guidance will be considered by FDA and the ICH M13 Expert Working Group. For information on how to comment, please see the Federal Register Notice. M13 is the first ICH guideline developed on harmonizing BE standards for generic drugs following the publication of the ICH reflection paper, “Further Opportunities for Harmonisation of Standards for Generic Drugs” (November 2018). M13 has three series. M13A serves as the first in the series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. The second guideline ICH M13B will describe biowaiver considerations for additional strengths, and the third guideline ICH M13C will include data analysis for highly variable drugs, drugs with narrow therapeutic index, and complex BE study designs. This guideline will result in the harmonization of current regional guidelines/guidances, that may reduce the need for additional in vivo BE studies, and support streamlined global drug development.
Generic Drug Cluster – One-Year Progress Report – multi-country forum established to address generic drug development globally.
FDA-EMA Parallel Scientific Advice Pilot Program – expansion of the FDA’s and European Medicines Agency’s existing parallel scientific advice for new drugs and biological products.
White Paper: Comparing FDA and EMA Decisions for Market Authorization of Generic Drug Applications covering 2017–2020

Overview of Generic Drug Global Program

Information and Resources

The links to resources below are intended to explain the generic drug program in the U.S. and provide navigational tools for foreign counterparts and information that assists industry in the development of generic drugs and their submission of abbreviated new drug applications (ANDAs).