An Adverse Event Is Not Always Obvious: A Practical Guide for Australian Listed Medicine Sponsors
For sponsors of listed medicines, pharmacovigilance does not begin when a report reaches the PV team. It begins when someone, somewhere in the organisation, first receives information about a possible adverse reaction.
That information might come through a customer complaint, an email to the sales team, a social media comment, a distributor or a conversation with a healthcare professional. It may not look like a conventional adverse event report, and the person receiving it may not realise that it requires further assessment.
This is where gaps in a sponsor’s pharmacovigilance system can emerge.
For Australian sponsors of listed medicines, including complementary medicines and supplements, having a process for collecting and managing safety information is essential. The challenge is ensuring that relevant information is recognised, documented and escalated, regardless of where it originates.
Common PV Mistakes Made by Supplement Companies with Products Listed on the ARTG
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.
Do You Really Need a QPPVA? Understanding Pharmacovigilance Responsibilities in Australia
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.
Event Coding in Pharmacovigilance (PV)
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.