Towards a Global Standard for Donation, Procurement, Testing, and Distribution of HSC and Related Cellular Therapies Position Paper (revised 27 May 2008)
|Essential Elements - Cells & Tissues for Administration|
This document is intended for use as a resource for new or developing programs. It does not contain the full requirements of standards but seeks to provide clear examples of compliance and additional detail to support basic quality system Elements.
Comparison of Cellular Therapy Standards
Note: These crosswalks were prepared for the purpose of providing basic information on organizational activities for global comparison and gap analysis. They ares NOT intended to be used as a reference or source document and are not endorsed by any of the participating organizations. All standards are undergoing revision at the time of web posting. Efforts will be made to update the information as soon as possible. Users are directed to each organization’s standards and accreditation policies for reference and the crosswalk should not take the place of a thorough line-by-line review of the Standards.
|1 Donor standards||13-12-2013||...|
|2 Scope & Definitions||13-12-2013||...|
|3 Regulation & Inspection||13-09-2010||...|
|4 Quality Management standards||15-07-2011||...|
|5 Cell Collection standards||14-10-2011||...|
|6 Labelling & Coding||07-06-2010||...|
|7 Cell Processing||15-07-2011||...|
|Import & Export Requirements||...|
|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.|
|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 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 Data Form document is a first step in supporting this international registry. We ask that you can send this document to the collection centres you are working with or fill it in yourself. WMDA will put the information in an international registry database, so that you can easily retrieve the information.
|WBMT - 2nd Workshop, Salvador -Bahia, Brazil|
|EBMT Congress, 2011, Paris|
|Harmonising Standards in SCT: An Update on AHCTA Initiatives||06-04-2011||...|
|Tandem Meetings, February 20, 2011|
|Harmonising Standards in SCT: An Update on AHCTA Initiatives||20-02-2011||...|
|AHCTA meeting, Goteborg, Sweden, 31 March 2009|
|Overview and Standards Comparison (Derwood Pamphilon, JACIE)||31-03-2009||...|
|EU Commission-Competent Authorities Meeting, 30th May 2008, Brussels|
|Import-export issues for HPC (Ineke Slaper-Cortenbach, JACIE)||30-05-2008|
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|ISCT Annual Meeting, Sydney, June 27, 2007|
|AHCTA Special Session at the ISCT meeting || |
|EU regulations for import and export of cellular therapy products||27-07-2007||...|
|US Regulations for Import and Export of Cell Therapy Products||27-07-2007||...|
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|FACT-JACIE-TGA workshop || |
|Implementing Standards Across International Borders (Linda Kelley, FACT).||27-07-2007||...|
|Implementing Standards Across International Borders: The European experience(Ineke Slaper, JACIE)||27-07-2007||...|
|Australian experience in using international standards for cell therapies||27-07-2007||...|