OBJECTIVES:  The EU Regulation no. 1394/2007 of the European Parliament on ATMP was adopted in 2007 – and with some procedural exemption implemented in full consequence up to 2012. All medicinal products based on gene therapy, somatic-cell therapy or tissue engineering launched in Germany since 2007 are by definition drugs – and should therefore fall since 2011 under the AMNOG process. The objective of this study is to assess how ATMP products have been evaluated by the German Federal Joint committee (Gemeinsamer Bundesausschuss – G-BA). METHODS:  All ATMP products launched in Germany have been analyzed to understand: (1) how many ATMP products went through a regular drug evaluation process defined by the §35a SGBV (AMNOG)? (2) In how many cases has the G-BA decided to use a different way of assessment (e.g. prior or during AMNOG times)? RESULTS:   In June 2016, 15 ATMP products in Germany have received either a valid centralized marketing authorization for the EU(7) or a national authorization pursuant to the special provisions of section 4bAMG (8 products). Two somatic cell therapy medicinal products are tumor vaccines and excluded. Of the remaining 13 products, 6 products have not been classified as drugs – and the evaluation is not completed: the reimbursement status of these products is unclear. One product (ChondroCelect) is covered under §135SGBV regulation since 1999 – and still on temporary status. Three products (Provenge, Glybera, Strimvelis) are covered within the AMNOG process. One assessment (Strimvelis) has only started June 2016. Two (one Orphan: Glyera), received a non-quantifiable benefit rating. Three products (MACI, Holoclar, C-Cure) are covered by §135/§137cSGB