IGBA, the International Generic and Biosimilar medicines Association, representing global manufacturers of generic and biosimilar medicines, announced today that ANAFAM has been accepted and welcomed as a new IGBA Associate Member.
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.
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.
- IGBA CEO Advisory Committee Vienna Statement - Four Keys to More Predictable Supply Chains (June 2023)
- IGBA detailed comments and proposals on the Pandemic Accord (Zero Draft - May 2023)
- IGBA Perspectives on Pandemic Accord (Zero Draft – April 2023)
- IGBA nominated David Gaugh, AAM's Interim CEO, as the new IGBA Chair for 2023 (April 2023)