FDA issues MAPP on complex product classification for generic development

The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are complex products for generic drug development purposes.

MAPP 5240.10, published on 13 April 2022, provides definitions and examples of complex drugs and drug-device combination products, as well as the responsibilities and procedures for the OGD’s Complex Drug Working Group. The MAPP is part of FDA’s larger Drug Competition Action Plan, which has improving the efficiency of generic drug development as one of its core aims.

Developers who plan to submit an abbreviated new drug application (ANDA) that references a complex product may be eligible for an enhanced pathway for discussions with the FDA. In 2020, FDA finalized guidance for industry on formal meetings about complex generic products, with details about meeting types and how to request meetings at each stage of the development and submission process (RELATED: FDA finalizes guidances on complex generics meetings, drug development tools, Regulatory Focus 25 November 2020).

As outlined in the GDUFA (Generic Drug User Fee Amendments) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022, complex products generally have one of the following elements:

a complex active ingredient
a complex route of delivery
a complex dosage form or formulation
a complex drug-device combination product
complexity/uncertainty that would benefit from early scientific engagement

The MAPP includes definitions of each of these elements and examples of approved complex products. The category on complexity/uncertainty that would benefit from early engagement includes any products where “complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.” For example, abuse-deterrent formulations of opioid drug products are part of this category. For these products, the agency recommends extensive physiochemical tests to determine if a proposed generic products meets the standard for “non-inferior abuse-deterrence.” Since early scientific engagement with the FDA is critical to the development of these products, abuse-deterrent products are classified as complex drug products.

FDA noted that the criteria for classifying complex products may evolve based on feedback from FDA’s Center for Drug Evaluation and Research and from industry, but OGD will use the MAPP criteria and examples when determining if a product is complex. “OGD will generally over-classify, rather than under-classify, complex products to ensure that generic applicants are sufficiently supported in their efforts to develop generic products,” FDA wrote.

Congress is currently considering the next reauthorization of GDUFA for 2023-2027, which could include some enhancements for developers of complex generics. The current GDUFA III goals letter, spells out points in the development and submission process when developers of complex generics would be able to seek meetings with FDA. The goals letter also states that FDA would publish quarterly metrics on the number of submissions of original ANDAs for complex generic products.

MAPP 5240.10

FDA issues MAPP on complex product classification for generic development

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