Regulatory Documents and Guidelines

An overview of key steps in developing regulatory guidelines was listed in a position paper published in Xenotransplantation in 2000 and a summary of regulatory documents for Xenotransplantation was presented in Osaka in 2013.

WHA 57^th World Health Assembly Transplantation Document (May 2004)
WHO Xenotransplantation Program (2005)
WHO Consultation on Xenotransplantation (Geneva, Switzerland - October1997)
WHO Xenotransplantation Advisory Consultation Report (Geneva, Switzerland - April 2005)
WHO Global Consultation Communique (Changsha, China - November 2008)
WHO Global Consultation Communique (Geneva, Switzerland - October 2011)
FDA Xenotransplantation Guidance: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry (CBER, 12/13/2016 )
SACX Informed consent (US DHHS June 2004)
PHS Guideline on Infectious Disease Issues in Xenotransplantation (2001)
Position Paper of the Ethics Committee of IXA (December 2002)
Cartagena Protocol on Biosafety (Montreal, 2000)
WHO Guiding Principles on Transplantation
SACX science of xeno (September 2004)
Summary of the SACX draft reports (Cooper, 2005)
FDA CVM Guidance 187 2009 (Updated 2015)
First update of the islet consensus statement (2015)

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