Regulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, October 2018)

Abstract

The aim of this document is to highlight the progress made with regard to advanced therapy products, the risks associated with such products, and the regulatory challenges they pose for Member States with a view to strengthening regulatory systems. The document is also a call to action for governments to consider the development of standards and rules for regulating these products in order to control the use of unapproved therapies and prevent risks to the population. As discussed, there are cross-cutting regulatory principles that should be implemented by any regulatory body that plans to undertake the regulation and oversight of advanced therapy products.