Global Bioequivalence Harmonisation Initiative (GBHI)

Since decades, bioequivalence is considered one of the key questions in new and generic drug product development and registration worldwide. At the same time, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country and continent to continent, although the scientific basis for it is globally the same. This aspect, and the on-going discussion on the suitability of reference products purchased from a specific country and their applicability for submissions in other countries or regions, create the necessity to conduct several only slightly different bioequivalence studies to get the same product authorised in various markets.

In order to contribute to improving the situation and acknowledging the benefit of previous conferences addressing certain aspects of controversies in BE assessment, EUFEPS (the European Federation for Pharmaceutical Sciences), with its Network on Bioavailability and Biopharmaceutics (BABP) in the lead, have agreed to set up a conference starting the Global Bioequivalence Harmonisation Initiative (GBHI). Accordingly, specific topics should be listed for scientific discussion, the intention being to identify common ground and arrive at a harmonised view among all parties involved.

The conference held in March 2015 in Amsterdam was a great success with more than 140 participants from academia, industry and ragulatories. A summary is going to be published soon.

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