Regenerative Medicine is a trendsetter in biotechnology with high medical need. The goal is to renew or replace diseased tissues with autologous or allogenic cells as well as human stem cells or xenogenic cells. The endogenous regeneration can also be induced by the application of agents and biomaterials. The results of Regenerative Medicine are innovative therapies during which stem cells, cells, tissues, regenerative agents and biomaterials are applied – in many cases also in combinations.

From a scientific, technical and ethical point of view cell- and tissue-based Regenerative Medicine products exhibit common features. Thus, they grouped under “Advanced Therapy Medicinal Products”. They clearly differ from conventional medicinal products and medical devices. However, health protection for patients must be guaranteed – just like for any other drug.

With a new general European regulation (Reg. 1394/2007/EC) the EU-Commission has implemented specific regulatory and technical requirements for the marketing of ATMPs. Now, these products will be developed and authorised as specific medicinal products with separate requirements under the umbrella of the pharmaceutical law (in Germany: German Medicines Law, AMG). Nevertheless, there are a number of exceptions for these products. Therefore, it is of utmost importance to clearly classify the end product for the successful development of a cell- and tissue-based medicinal product.

In Europe the reimbursement of ATMP differs strongly from state to state. To date, there is no transparency concerning the reimbursement by the public health insurances in Germany. Hence, it is advisable to clarify reimbursement issues at the very start of the development of ATMPs.