Generics Industry Seeks Greater Participation in the ICH

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 11-11-2014 14:01


Representatives from the generic-drug industry are seeking greater participation in harmonization efforts by gaining membership in the Executive Board of the International Conference on Harmonization (ICH). The International Generic Pharmaceutical Alliance (IGPA), an international network of generic-drug associations, issued a statement through the European Generic medicines Association (EGA) on its meeting with the Steering Committee of the ICH to lay out its interest for greater participation in the ICH. The ICH is meeting this week in Lisbon, Portugal.

IGPA Committee Representative David Gaugh provided an update. “The International Generic Pharmaceutical Alliance (IGPA) met yesterday [November 9, 2014] with the Steering Committee of the International Conference on Harmonization (ICH) to present details on the IGPA request to gain ICH Executive Board membership," he said in an EGA statement. "IGPA member associations represent companies making more than half of prescriptions worldwide. IGPA also represents companies that have moved into developing and manufacturing biosimilar medicines. Having participated in ICH since 1997, we have the utmost respect for ICH and what it has accomplished. What we seek now is a seat on the ICH Executive Board (formerly the Steering Committee). The Executive Board will perform the executive function for ICH. The ICH executive function has historically been performed by global regulators and brand pharmaceutical industry representatives without the beneficial input that the generic industry can provide. Even administrative decisions can significantly impact the outcome of a proceeding. We believe the generic industry should be a full part of those discussions and decisions. If IGPA is permitted to join the ICH Executive Board, it would fully participate in all decisions relating to ICH management and harmonization of global drug quality, safety, and efficacy standards. We would like to be full participants so that we can help ICH  represent public health in the 21st century."

In addition to the EGA, the IGPA consists of the Canadian Generic Pharmaceutical Association, the US Generic Pharmaceutical Association, the Jordanian Association of Pharmaceutical Manufacturers, the Japan Generic Medicines Association, and South Africa's National Association of Pharmaceutical Manufacturers. In addition, generic medicines associations from Australia, Brazil, Mexico, and Taiwan are associate members.

Source: European Generic medicines Association


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