ICH bioequivalence guideline paves the way for generic medicine development

The International Council for Harmonization (ICH) has initiated the process for a new guideline on bioequivalence requirements for the approval of medicines, which is an important milestone for global convergence.

The EU Pharmaceutical Strategy for Europe can build on this to enable global generic medicine development which is needed for better access to medicines and security of supply.

At the 2nd Bioequivalence Workshop, Gerald Beuerle, chairman of the trade group Medicines for Europe Bioequivalence working group, emphasized the importance of maintaining the principle of extrapolation of bioequivalence study results between different populations and that the current language in the sections on fed and fasting studies and pH dependency should be clarified to avoid unnecessary additional studies. Conflicting requirements between M13A and existing guidelines and product-specific guidance should also be addressed.