An analysis of advanced therapy medicinal products regulatory landscape in ICH member countries: opportunities and challenges

Advanced therapy medicinal products (ATMPs) represent a class of cutting-edge therapeutic modalities that offer a beacon of hope for treating a range of diseases that were previously incurable. The global demand for ATMPs is increasing, yet the regulatory frameworks and requirements are not harmonized, where several countries are actively working towards establishing specific regulations for this class of innovative therapies. This study analyses some key challenges of ATMP regulations, across International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory members, and highlights opportunities for regulatory convergence and reliance approaches across multiple jurisdictions to facilitate ATMP development and registration, and ultimately access to patients.