For many supplement companies, pharmacovigilance is not the first regulatory priority that comes to mind.

The focus is often on getting a product listed on the Australian Register of Therapeutic Goods (ARTG), maintaining manufacturing compliance, managing claims, and ensuring that labels meet regulatory requirements. Once the product is on the market, however, sponsors continue to have important responsibilities for monitoring and managing product safety.

This is where smaller supplement companies can sometimes find themselves exposed.

A product being a listed medicine does not mean that pharmacovigilance can be treated as a formality. Sponsors remain responsible for having appropriate systems in place to identify, assess, document, and report adverse events associated with their products.

Pharmaceutical companies often rely on various external vendors to support activities such as adverse event reporting, safety data processing, and regulatory intelligence. This responsibility extends beyond traditional vendors to include entities such as social media influencers and market research organisations (MROs) that may receive and process safety information. Ensuring that these vendors meet rigorous standards for quality, compliance, and data integrity is essential for maintaining the safety and efficacy of medicinal products.