Many sponsors assume that products classified as “low risk” require minimal pharmacovigilance oversight. In Australia, this assumption is particularly common among sponsors of listed medicines, complementary products, and over-the-counter consumer healthcare products.

However, regulatory classification does not eliminate safety risk. In fact, some of the most visible regulatory issues in recent years have involved products traditionally perceived as low risk, particularly sunscreens and listed medicines.

The challenge for sponsors is understanding that “low risk” in a regulatory context does not mean “low scrutiny,” “low exposure,” or “low reputational impact.”

Not all sunscreens are created equal, and ensuring their safety and efficacy falls under the purview of the Therapeutic Goods Administration (TGA).