as you may know, Committee for Advanced Therapies (CAT) of the European Medicinal Agency (EMA) issued recently Draft Letter related to more restrictions for cell therapies in EU. We at the International Consortium for Cell Therapy and Immunotherapy (ICCTI), including myself and both vice-presidents Prof. Klaus Ueberreiter and Prof. Virgil Schijns believe that those restrictions are rather a barrier for further progress with cell therapies in EU and are writing our comments that we plan to submit to EMA till the end of October 2014, which is the EMA deadline. The ICCTI Letter and Comments is already in a format required by CAT EMA.
I would like to ask you to join us or our partnering society STEMSO based in US (their comment is also enclosed) in writing your own letter that may be similar or the same as the ICCTI Letter to EMA in response to their CAT EMA Draft Letter which is attached. The more individuals, organizations, academia, companies, etc. related to cell therapies will object, the higher chance for less restrictions in Europe in the field of cell therapies can result.
Enclosed you can find also other relevant documents from the European Commission and from the House of Lords that express their ideas regarding cell therapies and regenerative medicine in Europe.
Please, act as soon as possible since the deadline for submission to EMA is comming soon on October 31, 2014. The ICCTI Letter and Comments is in a format required by EMA. You can submit your letter to:
- ICCTI – Letter and Comments on Reflection Paper on Classification of ATMPs 14-10-2014.doc [ 902 KB]
- STEMSO letter to CAT EMA 24-09-2014.doc [ 46,50 KB]
- Draft reflection paper 6-2014.pdf [ 319 KB]
- European Commission Report ATMP.pdf [ 90 KB]
- UK_HOUSE-OF-LORDS-regenerative-medicine-report.pdf [ 1,28 MB]