Paul-Ehrlich-Institut

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.

Its 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.