title: [The Innovation Office of the Paul-Ehrlich-Institut. Regulatory support during the scientific development of ATMP].
abstract: In conformity with Regulation (EC) No. 1394/2007, advanced therapy medicinal products (ATMP) are now subject to the centralized marketing authorization procedure. This also applies to most medicinal products in regenerative medicine. ATMP that have been marketed in a member state by the end of 2008 must be centrally authorized by the end of 2012 at the latest. In exceptional cases, a national authorization is acceptable. Developers of these medicinal products are usually academic institutions or small- and medium-sized enterprises (SME). They focus on scientific aspects and usually have little experience with pharmaceutical law. The Innovation Office of the Paul-Ehrlich-Institut (PEI) is designed to support developers of medicinal products in the areas between research and development, on the one hand, and regulatory requirements, on the other. Its main role is supportive advice in the regulatory field with an emphasis on ATMP. For this purpose, the Innovation Office makes use of core competences from various experts at the PEI in order to provide a quality consulting service to those companies who are seeking advice as early as possible and hand in hand with the development process. The aim is to support the developer to identify the appropriate regulatory pathway and to provide advice for each individual medicinal product at its corresponding stage of development in order to develop a high-quality ATMP manufactured on the basis of positive nonclinical results and appropriate clinical studies that meet all the necessary requirements for the application of a marketing authorization.
authors.affiliation: Leiterin des Innovationsbüros, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland. ziebe@pei.de
authors.forename: B
authors.initials: B
authors.lastname: Ziegele
authors.forename: L
authors.initials: L
authors.lastname: Dahl
authors.forename: A T
authors.initials: AT
authors.lastname: Müller
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D005858:Germany; D006077:Government Agencies / Q000331:legislation & jurisprudence*; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence*; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence; D012017:Referral and Consultation / Q000331:legislation & jurisprudence; D035703:Therapies, Investigational