NDRA Registration Waiver Process


National drug regulatory authorities (NDRAs) are mandated to ensure that all medicines and medical devices used in country are safe, effective, and of high quality. It is important to ensure that the drug is registered in-country through an NDRA. It may be possible to obtain an import waiver to enable importation of stringent regulatory authority approved products prior to NDRA review and approval to avoid delays in patient access to new products. This document outlines an illustrative process and requirements for national programs to request a waiver to make products accessible while national registration is underway.



1 view