The AAPS Journal

, Volume 18, Issue 4, pp 1039–1046 | Cite as

Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches

  • J.-M. Cardot
  • A. Garcia Arieta
  • P. Paixao
  • I. Tasevska
  • B. Davit
Regulatory Note

Abstract

The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.

KEY WORDS

BCS biowaiver EMA US-FDA 

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Copyright information

© American Association of Pharmaceutical Scientists 2016

Authors and Affiliations

  • J.-M. Cardot
    • 1
  • A. Garcia Arieta
    • 2
  • P. Paixao
    • 3
  • I. Tasevska
    • 4
  • B. Davit
    • 5
  1. 1.Faculté de PharmacieUniversité d’Auvergne Laboratoire de Biopharmacie EA 4678Clermont-FerrandFrance
  2. 2.Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use MedicinesAgencia Española de Medicamentos y Productos Sanitarios (AEMPS)MadridSpain
  3. 3.INFARMED—National Authority of Medicines and Health ProductsLisbonPortugal
  4. 4.State Institute for Drug Control (SÚKL)Praha 10Czech Republic
  5. 5.Translational MedicineMerck & Co.KenilworthUSA

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