Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the regulatory requirements to avoid delays in the evaluation of applications. This document should be used in conjunction with SAHPRA’s notification templates for nitrosamine risk evaluation or confirmatory testing and outcome of risk for nitrosamine investigation, available from SAHPRA’s website.

2022 Jun