European Regulatory Environment of RNA-Based Vaccines
The article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. In the EU, no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that the majority of mRNA-based vaccines have to be centrally approved. In addition to an overview on the current clinical use of mRNA vaccines in various therapeutic areas, a detailed discussion of the current regulatory situation is provided and regulatory perspectives are discussed.
Hinz T, Kallen K, Britten CM, Flamion B, Granzer U, Hoos A, Huber C, Khleif S, Kreiter S, Rammensee HG, Sahin U, Singh-Jasuja H, Türeci Ö15, Kalinke U. The European Regulatory Environment of RNA-Based Vaccines. Methods in Molecular Biology. 2017. Volume 1499. pp 203-222