title: [The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].
abstract: Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.
authors.affiliation: Abteilung Medizinische Biotechnologie, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland.
authors.forename: A
authors.initials: A
authors.lastname: Berger
authors.forename: S
authors.initials: S
authors.lastname: Schüle
authors.forename: E
authors.initials: E
authors.lastname: Flory
mesh_terms: D026683:Advisory Committees; D002568:Certification / Q000592:standards*; D003257:Consumer Product Safety / Q000592:standards*; D005062:European Union; D015316:Genetic Therapy / Q000592:standards*; D006801:Humans; D008389:Marketing of Health Services / Q000592:standards; D009313:National Health Programs; D011356:Product Labeling / Q000592:standards*; D011786:Quality Control; D033581:Stem Cell Transplantation / Q000592:standards*; D035703:Therapies, Investigational / Q000592:standards*; D023822:Tissue Engineering / Q000592:standards*