Chapter 25 – Strategies on adverse event reporting: a global framework for nutraceutical industry

It is ideal for regulatory affairs professionals to have a broad understanding of various regulated products and some of the major differences in their approval/marketing and postmarket processes. The pharmaceutical industry has a very comprehensive regulatory process in place to evaluate drug safety and efficacy which precedes any of the requirements or expectations for dietary supplement products globally. Therefore, despite the considerations that must be taken into account when monitoring the safety of nutraceuticals, the experiences of the pharmaceutical industry provide an excellent framework for adapting established pharmacovigilance methods to nutraceutical vigilance. This topic will use both US and global examples of existing postmarket regulations as a reference point for the pharmacovigilance framework being discussed. The major objectives of this topic are to help the reader/students gain perspective on the current state of global pre- and postmarket safety surveillance regulations for dietary supplements and also understand the practical application of pre- and postmarket safety surveillance strategies from an industry standpoint.