{"entity":{"id":"paul-ehrlich-institut","kind":"institution","name":"Paul-Ehrlich-Institut","aka":["PEI","Federal Institute for Vaccines and Biomedicines","Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel"],"tldr":"The German federal agency for vaccines and biomedicines, which regulates every CAR-T, gene therapy and cancer vaccine in Germany, often leads their assessment for the whole EU, and grants the hospital-exemption permissions that let a university hospital supply its own cell therapy.","summary":"Section 77(2) of the Arzneimittelgesetz gives the Paul-Ehrlich-Institut, based in Langen near Frankfurt and reporting to the Federal Ministry of Health, competence for sera, vaccines, blood preparations, tissue preparations, allergens, advanced therapy medicinal products, xenogeneic medicines and genetically engineered blood components; its own portfolio pages add monoclonal antibodies. For oncology that means the CAR-T products, oncolytic viruses, gene-modified and tumour-infiltrating cell therapies and therapeutic cancer vaccines. It authorises clinical trials of those products and says it frequently takes the rapporteur or co-rapporteur role in the EMA centralised procedure at the Committee for Advanced Therapies and the CHMP, often leading the assessment of the CAR-T products.\n\nIts most distinctive power is the hospital exemption. Section 4b AMG disapplies the marketing authorisation chapter for an advanced therapy prescribed for an individual patient, not routinely manufactured and used in a specialised healthcare facility under a doctor's responsibility, but supplying it still needs a permission from PEI, with the facilities named, the expected number of patients a year stated and a risk-management plan. PEI's published table of gene therapy medicinal products carries seventeen EU-authorised products and one national permission: HD-CAR-19 (heidagen-lecleucel), held by Universitätsklinikum Heidelberg since 23 September 2025. Four further national permissions appear in its somatic cell therapy and tissue-engineered product tables.","asOf":"2026-09-25","links":[{"label":"Paul-Ehrlich-Institut","url":"https://www.pei.de"},{"label":"The institute","url":"https://www.pei.de/EN/institute/institute-node.html"},{"label":"Gene therapy medicinal products authorised in Germany","url":"https://www.pei.de/DE/arzneimittel/atmp/gentherapeutika/gentherapeutika-node.html"},{"label":"Permissions under section 4b(3) AMG","url":"https://www.pei.de/DE/regulation/genehmigungen/atmp-4b-amg/atmp-4b-amg-node.html"},{"label":"Section 4b AMG","url":"https://www.gesetze-im-internet.de/amg_1976/__4b.html"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":[],"institutions":["ema","bfarm","heidelberg-nct","g-ba-iqwig"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-manufacturing-cell-therapy"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Langen","country":"DE","lat":50.006,"lng":8.672,"institutionType":"government","website":"https://www.pei.de","programs":["Authorisation and batch release of biomedicines","(Co-)rapporteur for ATMPs at CAT and CHMP","Clinical trial authorisation for biologicals","Hospital exemption permissions under section 4b AMG"]},"route":"/institutions/paul-ehrlich-institut/","neighbours":{"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"institution":[{"id":"bfarm","kind":"institution","name":"Bundesinstitut für Arzneimittel und Medizinprodukte","route":"/institutions/bfarm/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"g-ba-iqwig","kind":"institution","name":"Gemeinsamer Bundesausschuss / IQWiG","route":"/institutions/g-ba-iqwig/"},{"id":"heidelberg-nct","kind":"institution","name":"Heidelberg University Hospital / NCT / DKFZ","route":"/institutions/heidelberg-nct/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}