The FDA has published Manual of Policies and Procedures (MAPP) 5240.10, “Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products for Generic Drug Development Purposes.” The MAPP details the policies and procedures of the Office of Generic Drugs (OGD) for classifying which approved new drug products are complex products for generic drug development purposes. This includes drug-device combination products led by FDA’s Center for Drug Evaluation and Research (CDER). Prospective applicants who plan to submit an abbreviated new drug application (ANDA) referencing a complex product may be eligible for an enhanced pathway for discussions with FDA.
According to the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 commitment letter, a complex product generally includes one or more of the following five features:
- A complex active ingredient
- A complex route of delivery
- A complex dosage form or formulation
- A complex drug-device combination product
- “[C]omplexity or uncertainty concerning the approval pathway or [a] possible alternative approach [that] would benefit from early scientific engagement”
Although the criteria for classifying complex products may evolve over time based on feedback from CDER and from industry, currently, OGD generally uses the criteria and examples detailed in this MAPP to determine 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. For full details, please refer to the MAPP.
The agency is publishing this MAPP as part of the Drug Competition Action Plan, which aims to facilitate more generic competition, promote patient access, and ultimately improve health care costs.
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