27 June 2018

The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.

The M9 draft Guideline provides recommendations to support the biopharmaceutics classification of medicinal products and provides recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of current regional guidelines/guidance and support streamlined global drug development.

The ICH M9 draft Guideline can be downloaded on the Multidisciplinary page on the ICH website.

You may provide comments on the ICH M9 Draft guideline by e-mailing the ICH Secretariat. More details under the Public Consultation page.

Please note that stakeholders from ICH Regions are encouraged to submit their comments to their respective Regulatory Authorities.