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Last updated: 8 March, 2010

Mission statement
Towards a Global Standard for Donation, Procurement, Testing, and Distribution of HSC and Related Cellular Therapies Position Paper (revised 27 May 2008)
   
Surveys
Import & Export Requirements word icon
This import- and export survey was originally started in 2003. In 2009 WMDA began updating the data and  you are invited to participate here.
The data already collected by this survey is available on the WMDA website under 'Regulatory'. 
EU Directive 2004/23/EC requirements for products sources from third countries. word icon
The EU Directive 2004/23/EC (article 9) says: Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive.

AHCTA (www.ahcta.org) supports the creation of an international registry of tissue and cell establishments in order to facilitate this international movement of tissues and cells..

The Collection center - cord blood bank document is a first step in supporting this international registry. We ask that you can send this document to the collection centres and cord blood banks you are working with or fill in by yourself. We will put the information in an international registry database, so that you can easily retrieve the information.
Slides  
AHCTA meeting, Goteborg, Sweden, 31 2009
Overview and Standards Comparison (Derwood Pamphilon, JACIE)

EU Commission-Competent Authorities Meeting, 30th May 2008, Brussels
Import-export issues for HPC (Ineke Slaper-Cortenbach, JACIE)

PDF

   
ISCT Annual Meeting, Sydney, June 27, 2007
AHCTA Special Session at the ISCT meeting  
Introduction
EU regulations for import and export of cellular therapy products
US Regulations for Import and Export of Cell Therapy Products
   
FACT-JACIE-TGA workshop  
Implementing Standards Across International Borders (Linda Kelley, FACT).
Implementing Standards Across International Borders: The European experience(Ineke Slaper, JACIE)
Australian experience in using international standards for cell therapies