IGBA Elected to Management Committee of ICH

This week, the International Generic and Biosimilar Medicines Association (IGBA) was elected as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The ICH works to achieve “greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner,” according to their mission statement.

The Management Committee of the ICH is a distinguished group of ICH members that help to oversee the operational aspects of ICH on behalf of all members, including administrative and financial matters, in addition to the oversight of working groups.

IGBA joined the ICH in June 2016 as a General Assembly member. With its newly elected role, the IGBA will be represented at Management Committee meetings by 2 current IGBA representatives.

“To join the ICH as Management Committee’s Member is a historical moment for our industry and next milestone for the generic and biosimilar industries’ engagement in the international harmonization process,” said Nick Cappuccino, chair of the IGBA science committee and one of IGBA’s representatives to the ICH General Assembly, in a statement.

The IGBA believes that, by being more deeply involved with the ICH Management Body, it can drive deeper integration of ICH regulatory standards among its own membership. This working partnership will in turn, it says, benefit patients worldwide and provide them with access to high quality, safe, and effective generic and biosimilar medicines.

“The positive decision of the ICH to elect the IGBA as a Management Committee Member reflects the recognition of values and expertise which the generic and biosimilar pharmaceutical industries can bring to the scientific discussion at the ICH,” said Beata Stepniewska, the second IGBA representative to the ICH General Assembly.