Many Australian medicine sponsors are familiar with the concept of a Qualified Person for Pharmacovigilance (QPPV), particularly if they operate internationally. However, there is often confusion around what the role means in the Australian context and how it differs from pharmacovigilance arrangements in other jurisdictions.

Australian sponsors are expected to have a QPPV as part of their pharmacovigilance system. In addition, sponsors must have a pharmacovigilance contact person residing in Australia who can be contacted by the Therapeutic Goods Administration (TGA).

While these requirements may appear straightforward, the real challenge lies in ensuring that the individuals fulfilling these roles have appropriate oversight of the Australian pharmacovigilance system and understand the unique characteristics of the Australian market.

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.”

For many sponsors, a pharmacovigilance (PV) inspection by the Therapeutic Goods Administration (TGA) can feel unpredictable. In reality, inspections are rarely random. They are typically preceded by identifiable risk factors, compliance signals, or changes within a sponsor’s operations.

Understanding these triggers is not about avoiding scrutiny, but about ensuring that your PV system is capable of withstanding it. Sponsors that recognise early warning signs are better positioned to maintain compliance and respond effectively if inspected.

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.

In pharmacovigilance, where data integrity, security, and accessibility are critical, the IT department serves as an essential partner to ensure compliance and smooth operations. IT involvement spans across several key areas, including secure data exchange, system transfers, business continuity planning, and robust system security.