The Assembly adopted three new topics for harmonisation at the Vancouver meeting, with the starting timeframe to be determined in a subsequent step:

  • “General Considerations for Patient Preference Studies” – a new ICH Efficacy Guideline which will provide considerations for a systematic approach to designing, conducting, analyzing and presenting Patient Preference Studies
  • “Nonclinical Safety Studies for Oligonucleotide-based Therapeutics” – new ICH Safety Guideline which will clarify regulatory expectations on nonclinical safety evaluation of various Oligonucleotide-based treatment options
  • “Bioequivalence for Modified-Release Products” – a new ICH Multidisciplinary Guideline which represents an important next step for harmonisation of bioequivalence standards for more complex dosage forms

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.