Global regulators and biopharmaceutical and vaccine industry to share experiences with managing pharmaceutical quality systems (July 2023)

On 20 July 2023, the International Coalition of Medicines Regulatory Authorities (ICMRA) is hosting a virtual workshop on the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS), which aims to facilitate the exchange of knowledge related to pharmaceutical quality amongst national regulatory authorities worldwide.


IGBA Welcomes ICH New Topic for Harmonisation: “Bioequivalence for Modified-Release Products” (June 2023)

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.

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