Tokyo, Japan (June 7, 2018)

The International Generic and Biosimilar Medicines Association (IGBA) very much welcomes today’s decision of the ICH General Assembly to elect the IGBA as an Management Committee Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use  (ICH). 

After joining the ICH as a full member  of General Assembly in June 2016, the membership in the Management Committee (MC) is an important next step in IGBA-ICH relationship . Since June 2018, the IGBA will be represented in the ICH Management Committee by Nick Cappuccino and Beata Stepniewska, current IGBA representatives to the ICH General Assembly.

“To join the ICH as Management Committee ‘s Member is a historical moment for our industry and next milestone for  the generic & biosimilar industries’ engagement in the international harmonization process” commented Nick Cappuccino, the  Chair of the IGBA Science Committee. We strongly believe that, having contributed to the ICH work as an interested party during the last 20 years, we can now open a new chapter of engaging fully in the ICH activities of developing the international standards applied to the pharmaceutical industry, including generic and biosimilar manufacturers”.

“The IGBA is very much looking forward to playing a constructive role in the ICH, engaging actively in various Experts Working groups through the representation of our members across the five continents” said Beata Stepniewska, the IGBA representative to the ICH General Assembly. 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. “

Generic and Biosimilar medicines industries are now global industries well positioned to continue contributing to the harmonisation of the scientific and regulatory standards led by the ICH. Deeper integration and involvement of the IGBA in the ICH Management body will clearly contribute to development and promotion of the ICH regulatory standards among the IGBA membership in the benefit of patients’ worldwide, having an access to high quality, safe and efficacious generic and biosimilar medicines.

About IGBA

The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines from around the world. Its membership includes AAM (USA), CGPA (Canada), GBM – Southern Africa (South Africa), IPA (India), JAPM (Jordan), JGA (Japan), Medicines for Europe (Europe), and TGPA (Taiwan), while the associations from Australia (GBMA), Brazil (ProGenericos), Mexico (AMEGI), and Malaysia (MOPI) are Associate Members. The IGBA is at the forefront of preserving sustainable competition within our industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality, pro-competitive medicines. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities around the world, as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org