The International Generic and Biosimilar Medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of "Bioequivalence for Modified-Release Products." This significant development, which took place at the recent ICH meeting in Vancouver, Canada, marks the introduction of a new ICH Multidisciplinary Guideline, which aims to further strengthen consensus and harmonisation among ICH members regarding bioequivalence standards for more complex dosage forms. These efforts build upon the existing harmonisation initiatives found within the upcoming M13 series of bioequivalence guidelines.

Vienna, June 14, 2023 - The COVID-19 pandemic demonstrated the critical importance of resilient global supply chains. As the CEO Advisory Committee of the International Generic and Biosimilar Medicines Association (IGBA), we underscore the essential role of the off-patent pharmaceutical sector in ensuring that patients worldwide have equitable access to quality-assured, and affordable medicines.

IGBA is pleased to share key comments and proposals on selected provisions of the Zero Draft of the Pandemic Accord