Abstract
Cellular therapy products are an emerging medical product class undergoing rapid scientific and clinical innovation worldwide. These products pose unique regulatory challenges both for countries with existing regulatory frameworks and for countries where regulatory frameworks for cellular therapy products are under development. The United States Food and Drug Administration (US FDA) has a history of productive working relationships with international regulatory authorities, and seeks to extend this to the cellular therapy field. The US FDA and its global regulatory counterparts are engaged in collaborations focused on the convergence of scientific and regulatory approaches, and the education of scientists, clinicians, regulators, and the public at large on the development of cellular therapies.
Highlights
The field of cellular therapies is undergoing rapid scientific and clinical innovation, and product development and clinical investigations are frequently conducted internationally
At the Regulators Forum (RF) held in November 2010 (Fukuoka, Japan) in association with the ICH, US United States Food and Drug Administration (FDA) proposed that the RF consider undertaking a preliminary assessment of potential topics of regulatory importance for cellular therapy products
The intent of these efforts is to provide a forum for discussions among international regulatory authorities on the convergence of regulatory perspectives
Summary
The field of cellular therapies is undergoing rapid scientific and clinical innovation, and product development and clinical investigations are frequently conducted internationally. At the Regulators Forum (RF) held in November 2010 (Fukuoka, Japan) in association with the ICH, US FDA proposed that the RF consider undertaking a preliminary assessment of potential topics of regulatory importance for cellular therapy products The intent of these efforts is to provide a forum for discussions among international regulatory authorities on the convergence of regulatory perspectives. Cellular Therapy Convergence Efforts by the Regulators Forum (ICH) The Regulators Forum is composed of: ICH members (US FDA, EMA, and Japan PMDA/MHLW); ICH observers (Canada, European Free Trade Association (EFTA), WHO); regional harmonization initiatives (APEC, Association of the Southeast Asian Nations (ASEAN), Southern African Development Community (SADC), Gulf Cooperation Council (GCC), Pan-American Network for Drug Regulatory Harmonization (PANDRH)); individual drug regulatory authorities from Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia, and Singapore. The final report of the workshop will be presented to APEC, ICH, and the RF
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