Requirements for the registration of human CBMPs for the European market

The European Medicines Agency (EMA) regulates the basic requirements for the registration of human CBMPs for the European market. In its “Guideline on human cell-based medicinal products” (EMEA/CHMP/410869/2006), EMA describes CBMPs as heterogeneous and considers that product-specific case-by-case testing strategies are needed, rather than conventional non-clinical pharmacology and toxicology studies. It further recommends early presentation of these individual, risk-based strategies for preclinical evaluation to the drug registration authorities for discussion. With our long-standing expertise in preclinical testing of new drugs, including safety-relevant studies according to GLP, we are in a position to adequately support our clients in all contexts of preclinical testing of heterogeneous cell-based therapies. This includes initial consulting to set up an appropriate testing strategy and early interaction with the competent authorities to ensure regulatory compliance of the developed strategy. The complex assays and studies are then validated and performed according to the relevant quality standards.