Application for central authorisation submitted to the EMA
TETEC AG has submitted the application for central approval of a gel-based matrix-associated cartilage cell product as an Advanced Therapy Medicinal Product (ATMP) to the EMA (European Medicines Agency).
With the submission of the application for central marketing authorisation in the European Union (EU), TETEC AG has taken a major step towards the Europe-wide marketing of its cartilage therapy products. The company's management would like to thank all employees for their tireless commitment and excellent cooperation.
For several years now, preparations have been underway at TETEC AG to make the cartilage therapy products available to users and patients in the EU. In order for an ATMP to be used in the EU, studies must first be carried out, which are then submitted to the European Medicines Agency. That's why we would like to thank all our users. Without the use of these products and the proof of efficacy and safety in clinical trials and in everyday orthopaedic practice, such an approval process would not be feasible.
The European Medicine Agency will review the submitted documents and, in the event of a positive assessment, will then recommend to the European Commission that the gel-based matrix-associated TETEC product be approved in the EU for cartilage therapy.