ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A
ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived compounds (small molecule), or proteins or peptides expressed by cellular systems (large molecule). It is not surprising that there are regulations and guidance specifically for ATMPs such as EudraLex Volume 4, Part IV (EMA) and PIC/S Annex 2A. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines.