… Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in … Regulatory Authorities … the industry-scale production of these therapies for supporting clinical development and commercialisation. This …
… This means that they are not submitted to the standard regulatory pathway as other ATMPs, i.e. the mandatory … ). Actors, including the European Commission, the EMA, and National medicines agencies are aware of the issues … from hospital exemption national pathways should be used to support marketing authorisation applications of non-exempted …
… a single application to the European Medicines Agency (EMA) and its scientific assessment by the Committee for … Almost half of them benefited from expediting pathways or regulatory support schemes for (innovative) medicines to be …
… or metabolic actions of the manipulated cells. An EMA-approved example is using properties of MSCs … but results from these studies provide information for regulatory agencies to determine whether the product should … . There are also early support regulatory schemes from national competent …