TESTING REQUIREMENTS: T Pallidum (n=25)

1. TESTING REQUIREMENTS: T Pallidum (n=25) MORE STRINGENT REQUIREMENTS: 0 Member States EC REQUIREMENTS : 20 Member States + 1 EFTA countries LOWER REQUIREMENTS: 3 Member State + 1 EFTA Country

2. TESTING REQUIREMENTS: Other requirements CMV. HTLV I-II. PVB19 HTLV I-II CMV. Toxoplasma. EBV. CMV. EBV.

3. FUTURE INITIATIVES • EU Guidelines Coding system for tissues and cells • EU Guidelines for inspections and training of inspectors • EU Guidelines for Quality Systems • IT support for the technical requirements • EU mechanism import /export for tissues and cells

4. Future initiatives on SoHO • EU Guidelines Coding system for tissues and cells • CEN Workshop agreement (April) • Exchange of views CA meeting May • Adoption end 2008

5. EU Guidelines Coding system for tissues and cells

6. Inspections Number of countries that conducted inspections already: 12

7. Future initiatives • EU Guidelines for inspections and training of inspectors • EUSTITE Open consultation Final Guide of Inspection (until 4th April) • http://www.eustite.org • Presentation CA meeting May

8. Future initiatives • EU Guidelines for Quality Systems • Call for tender : ALCIMED

9. SAE/SAR

10. Future initiatives • Serious adverse event/reaction reporting (2008) • First reporting to the Commission: 30 June 2008, concerning information collected during the complete year 2007 (from 1st September to 31st of December) • EUSTITE presentation on CA meeting May • Blood Common approach

11. Future initiatives • EU mechanism import /export for tissues and cells • Exchange of views CA meeting May 2008 • ISCT Round table: FDA dialogue

12. The public health programme • Proposal for a new programme on health (2008-2013)

13. Blood Standard operating procedures for collection and processing Standards for inspections Optimal use Tissues and cells Standards and training for inspections Quality system for tissue banking Standards for hematopoietic stem cells Coding and classification of pre-implantation genetic diagnosis PROJECTS FUNDED IN 2003-2006 Organs • Training programme on organ donation • Living donation

14. HUMAN SUBSTANCES. PRIORITIES 2008 (I) • Specific questions related to blood, tissues, cells and organs remain on the promotion of voluntary unpaid donations, inspections, electronic exchange of data and optimal use. • For the implementation of the tissues andcells directives traceability, coding and reporting systems for adverse events should be established at community level. • There is a need to support projects that help in managing import and export, registers and reporting obligations of the directives. Stem cells, reproductive cells and new human derivatives are special cases that will require specific attention. • On organs, improving quality and safety, increasing organ availability and making transplantation systems more efficient and accessible will require further work following the Commission Communication on organ donation and transplantation.

15. HUMAN SUBSTANCES. PRIORITIES 2007 (II) In 2008, the following projects will be prioritised: • — Evaluation of post transplant results on organ transplantation: Promote common definitions of terms and methodology to evaluate the results of transplantation. Promote register or network of registers to follow-up on organ recipients, monitor their health and evaluate results. [Financing mechanism: Call for proposals] • — Analysis and comparison of the validation and certification of testing methods and testing laboratories in the EU and third countries for the biological markers specified in the blood and tissues and cells Directives. Implications on import and exports of blood, blood components, tissues and cells from and in the third countries [Financing mechanism: Call for tender] • — Ad hoc cooperation with the Council of Europe on specific matters related to human substances (blood, tissues, cells, organs). [Financial mechanism: Direct grant agreement with CoE]

16. Thank you