As part of our work with the Department of Health and Social Care’s ATMP data subgroup, we (CGT Catapult/CERSI-AT) have developed a guide that describes and discusses each component of the non-clinical process for ATMPs to help developers navigate the UK’s non-clinical regulatory frameworks.
Advanced Therapy Medicinal Products (ATMPs) are cutting edge medicines for human use that are based on genes, tissues or cells. Unlike established therapies such as small molecule pharmaceuticals and biotechnology-derived pharmaceuticals, which have well-defined non-clinical development pathways, the non-clinical evidence generation requirements for ATMPs differ from these types of medicines. Due to their unique nature, each ATMP requires a tailored-made approach, and this resource helps to clarify and guide ATMP developers accordingly.
This guide cites the European Medicines Agency (EMA)’s non-clinical guidelines which are the accepted non-clinical guidelines for ATMP development in the UK. Where appropriate, we refer to other guidance, such as the International Council for Harmonisation (ICH) and guidance published by the Food and Drug Administration (FDA).
