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A biowaiver under the Jordan Food and Drug Administration (JFDA) guidelines is a Regulatory approval that allows a pharmaceutical manufacturer to skip in vivo bioequivalence (BE) studies in human volunteers.

Instead of testing the drug in humans to prove it performs the same as the innovator (reference) product, the JFDA allows the use of comparative in vitro dissolution testing as an alternative.

Eligibility Criteria:

Biowaiver eligibility under JFDA guidelines is based on the following key factors:

  • BCS Classification:
    In line with the ICH M9 Guideline (implemented in Jordan since April 2025), biowaivers are typically granted for:
  • Dosage Form:
    This pathway is limited to immediate-release oral solid dosage forms, such as tablets and capsules, intended for systemic action.
    1. 1. BCS Class I (high solubility, high permeability)
    2. 2. BCS Class III (high solubility, low permeability)
  • Sameness of Excipients:
    For BCS Class III drugs, the JFDA applies stricter requirements. The excipients in the generic product must be similar to those in the reference product, both in type and quantity, to ensure they do not affect drug absorption.
  • Additional Scientific Considerations:
    The JFDA considers the following aspects when reviewing a biowaiver study: linear pharmacokinetic determinants, solubility study, permeability study, and in vitro dissolution study.

Why it Matters in Jordan:

The JFDA follows a risk-based approach when evaluating biowaiver applications. By obtaining a biowaiver, manufacturers can reduce development costs and bring generic products to market faster.

However, the JFDA may not grant a biowaiver for drugs with a narrow therapeutic index (such as warfarin or digoxin), where small differences in drug levels can impact patient safety.

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