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.”

Pharmacovigilance (PV) is a regulatory obligation, but in practice it is often treated as a secondary function until something goes wrong. The Therapeutic Goods Administration (TGA) continues to identify recurring deficiencies across sponsors of all sizes, particularly within listed medicines and complementary products. These findings are rarely due to a lack of intent; more often, they reflect gaps in systems, oversight, and practical implementation

In pharmacovigilance, follow-ups are crucial for gathering comprehensive and accurate data on adverse events associated with pharmaceutical products. In Australia, where pharmacovigilance standards align with stringent Therapeutic Goods Administration (TGA) requirements, follow-up procedures are structured to ensure timely, detailed, and effective case assessments, particularly for special cases like pregnancy reports. This article explores how to conduct effective follow-ups in pharmacovigilance, detailing the specific requirements, techniques for data collection, and specialised guidance for handling pregnancy cases.

Organised Data Collection Systems (ODCS) are essential to pharmacovigilance, ensuring systematic, comprehensive, and reliable data collection to monitor and improve drug safety.

Event coding in PV stands out as a critical process. A systematic and standardised approach to coding adverse events and medical terms is essential for efficient signal detection, risk management and regulatory reporting.