ICH Reorganizes as International Council for Harmonization

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 11-03-2015 13:46


The International Council for Harmonization (ICH), formerly the International Conference on Harmonization, held the inaugural meetings of its new Assembly and Management Committee on October 23, 2015.

As part of announced changes, ICH is encouraging more involvement from regulators globally to join their counterparts from Europe, Japan, the US, Canada, and Switzerland as ICH regulatory members. This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonization.

ICH said the changes give ICH a more stable operating structure through the establishment of an ICH association, a legal entity under Swiss law. The association established the new Assembly as the over-arching governing body that will be instrumental in facilitating future growth through the participation of new members.

At the end of the inaugural meeting, ICH Assembly members issued a statement: “The fundamentals of what the ICH parties are trying to achieve are not changed, but the reforms to the process and organisation were needed to adapt to changes in how medicines are developed and regulated. These changes mark an exciting moment for us to help harmonize and streamline the global drug development process for the benefit of patients around the world.”

The International Generic and Biosimilar Medicines Association (IGBA) is welcoming the changes by the ICH and the opening of the process to new members, including international industry organizations. The IGBA said it looks forward to joining the ICH Assembly and in accordance with the new process, to play a constructive role in the Management Committee.

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. Its membership includes the EGA (Europe), the CGPA (Canada), the GPhA (US), the JAPM (Jordan), the NAPM (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos) and Mexico (AMEGI) are associate members.

Source: ICH and IGBA


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