The tightly regulated roles of pharmacovigilance and regulatory affairs are understood to have their own separate specialized functions. Nevertheless, to achieve their shared objective of protecting public health, it is crucial that they collaborate effectively. When pharmacovigilance (PV) teams identify safety signals from global sources or health authorities (HA), they inform the regulatory affairs (RA) department, as updates to product information documents and safety details provided to healthcare professionals and patients may be required.
Collaboration between regulatory and PV teams should begin prior to registration and continue throughout the product’s lifecycle. One such example is the Risk Management Plan (RMP) that details how the company will monitor safety and address potential risks during routine post-registration use. When safety updates influence the RMP or associated materials, PV professionals should be consulted to ensure these documents, and any associated risk minimization materials, are properly reviewed and revised. PV professionals are responsible for assessing the extent to which the risk minimization is successful and, if necessary, refining or changing the measures. For their part, RA professionals are responsible for ensuring that updates to the RMP are in line with regulatory requirements. Therefore, seamless cooperation between regulatory and PV teams is essential to achieve optimal outcomes.
In Australia, the Therapeutic Goods Administration (TGA) recognizes that most RMPs are created for use in the European Union and United States. Therefore, the TGA seeks to understand whether the company intends to implement similar PV activities locally[1]. To achieve this, the Australian Specific Annex (ASA) to the RMP is included alongside the EU RMP or US RMP as part of the submission documents (Module 1.8.2). Typically, regulatory professionals collaborate with PV experts to ensure that the ASA aligns with Australian requirements[2]. The TGA evaluates both the RMP and ASA, and any inquiries are addressed by the sponsor (whether local or global), regulatory, and PV teams.
As the product enters the market and additional safety data emerges through real-world use, the EU RMP may be updated, necessitating corresponding updates to the ASA. These revisions are conducted collaboratively between the regulatory and PV teams. Additionally, the TGA mandates that sponsors establish a local PV contact and system to continuously monitor the safety of the medicine and identify any safety signals at the national level1. These signals, often detected through adverse event reporting, may prompt changes to the company’s core safety data. Such changes are then reflected in the local product information text, and regulatory professionals submit an application to the TGA to implement these updates. The collaboration between the PV and regulatory teams for safety related updates to the local product information ensures that healthcare professionals and patients have access to the most up-to-date safety information.
The PV responsibilities also encompass post-marketing surveillance studies, which assess the long-term safety profiles of medications and offer crucial insights into their real-world application.
This synergistic collaboration between regulatory affairs and PV ensures that potential risks are identified, analyzed, and mitigated throughout a medication’s lifecycle, from pre-approval stages to post-marketing surveillance.
RA and PV are essential pillars of the pharmaceutical industry, each playing unique yet interconnected roles in guaranteeing the safety and efficacy of medications. While RA is dedicated to the pre-approval stages, ensuring regulatory compliance throughout drug development and submission processes, PV focuses on the post-approval phase, monitoring and managing risks associated with real-world use.
Together, these two fields work harmoniously to uphold the highest standards of quality, safeguarding public health. Their partnership drives the ongoing enhancement of drug safety and contributes significantly to the well-being of patients by ensuring doctors and patients in Australia and globally have access to the most current safety information about their medicine.
Co-authored:
Robert Martini is Senior Manager, Regulatory Affairs, Australia, where he brings more than 30 years of regulatory experience. supporting global multinational pharma companies and local Australian businesses.
Victoria Rogers, Associate Director, Team Lead, Pharmacovigilance, Australia, with over 10 years of experience as a pharmacist manager. Victoria is passionate about leading a team with a strong focus on promoting patient safety and how to bridge her expertise from pharmacy practice to the pharmaceutical industry.
[1] Pharmacovigilance responsibilities of medicine sponsors, TGA. Pharmacovigilance responsibilities of medicine sponsors | Therapeutic Goods Administration (TGA)
[2] https://www.tga.gov.au/resources/guidance/submitting-risk-management-plans-medicines-and-biologicals
