Biowaiver

Regulatory Affairs and Compliance

Biowaivers for Fixed-Dose Combination (FDC) Drug Products
ByPharma Lesson April 4, 2025April 4, 2025 Reading Time: 2 minutes

Fixed-dose combination (FDC) drug products present unique challenges in biowaiver assessments, as they involve multiple active pharmaceutical ingredients (APIs) with different physicochemical properties and release characteristics. Regulatory guidelines (USFDA, EMA, WHO) provide biowaiver provisions, but their applicability depends on several factors, such as API solubility, permeability, formulation type, and release mechanisms. Key Considerations for Biowaivers…

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Formulation

SUPAC Guidance on Qualitative Changes in Excipients
ByPharma Lesson March 14, 2025March 14, 2025 Reading Time: 2 minutes

SUPAC Guidance on Qualitative Changes The USFDA SUPAC (Scale-Up and Post-Approval Changes) guidance categorizes formulation changes based on their impact on product performance. A qualitative change refers to the replacement or removal of an excipient, classified as a Level 3 change, which is considered major and requires regulatory approval. Key Regulatory Requirements for Level 3…

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Biowaiver

Biowaiver for Topical Dosage Forms
ByPharma Lesson February 22, 2025February 22, 2025 Reading Time: 2 minutes

A Biowaiver for a topical dosage form refers to regulatory approval for marketing a generic topical product without conducting in vivo bioequivalence (BE) studies. Instead, equivalence is demonstrated using in vitro methods and other scientific justifications. Key Considerations for Biowaiver of Topical Dosage Forms Regulatory agencies such as USFDA, EMA, and WHO provide guidelines for…

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Biowaiver

Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies
ByPharma Lesson February 21, 2025February 21, 2025 Reading Time: 2 minutes

When BE is demonstrated for one strength of a drug product, regulatory agencies allow a biowaiver for additional strengths under certain conditions. The key criteria vary across USFDA, EMA, WHO, MHRA, TGA, and CDSCO but are largely aligned on fundamental principles. USFDA Biowaiver Criteria Biowaiver is allowed for additional strengths if: EMA Biowaiver Criteria Follows…

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Biowaiver

Biowaiver for BCS Class 1 Drugs
ByPharma Lesson February 21, 2025February 21, 2025 Reading Time: 2 minutes

A biowaiver allows a generic drug to be approved without an in vivo (BE) study based on in vitro dissolution data. This is particularly applicable BCS Class 1 drugs, which have high solubility and high permeability. Biowaiver Justification for BCS Class 1 Drugs To obtain a biowaiver for a BCS Class 1 drug, the following…

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