Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Opens Consultation on Biopharmaceutics Classification System Based Biowaivers

The aim of the guideline is to avoid duplication of research for pharmaceutical and generic products
22 Aug 2018
Bioethics, legal and economic issues

On 6 August 2018 the European Medicines Agency (EMA) launched an open consultation on a guideline for a biopharmaceutics classification system (BCS)-based biowaivers. The aim of the guideline is to avoid duplication of research for pharmaceutical (and generic) products and ensure harmonisation of differentiated regional guidelines. 

Biowaivers can be granted to (re)use data of the in vitro data as the bioequivalent of in vivo data. Consequently, duplication of research can be avoided, and thus unnecessary additional human testing. 

Medical authorities, such as the EMA, use a BCS to categorise the drug substances. The BCS is divided into four classes. However, BCS based-biowaivers are not recognised worldwide for class I and III drugs. Therefore, pharmaceutical companies have to follow different approaches in different regions. The proposed guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of differentiated regional guidelines and support streamlined global drug development. 

BCS-based biowaivers may be used for different purposes, including to demonstrate bioequivalence between products in early clinical development, or in applications for generic drug products. Therefore, a BCS-based biowaiver has become an important and cost-saving tool in approval of generic drugs. 

The consultation will be open for feedback until 6 February 2019 and can be sent to ich@ema.europa.eu.

The guideline for the BCS-based biowaivers is available here.

Last update: 22 Aug 2018

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings