Having the right local setup to comply with country pharmacovigilance obligations

As pharmaceutical companies expand their global footprint, they are confronted with the complexities of pharmacovigilance (PV) requirements across various regions. Each market brings unique regulatory challenges, particularly for Marketing Authorization Holders (MAHs), who must comply with diverse national and regional safety reporting standards. Meeting these requirements is crucial for patient safety and maintaining a company’s business reputation. However, the task is not always straightforward, especially for companies dealing with novel therapies and high-risk products such as Advanced Medicinal Therapy Products (ATMPs). 

The Growing Complexity of Global Pharmacovigilance 

The increasing need for effective pharmacovigilance is driven by the global expansion of pharmaceutical products. However, navigating the landscape of local safety regulations can be a daunting task. Each country and region have their own set of rules and procedures for individual case safety reporting (ICSR), making it challenging for MAHs to remain compliant while ensuring the safety of their products. 

In the European Union (EU), for example, products with centralized marketing authorization from the European Medicines Agency (EMA) must still comply with local PV requirements across 30 EU and European Economic Area (EEA) countries. Even more challenging, 17 EU member states mandate that companies maintain a local pharmacovigilance presence even if the product is not marketed in that country. 

The Unique Challenges of Novel and High-Risk Therapies 

For companies working with novel therapies like ATMPs, the complexity increases significantly. These therapies often come with higher safety management costs, more extensive risk minimization measures (RMM), and increased regulatory obligations. The EU, for instance, requires stricter safety reporting for these therapies, which can place additional strain on a company’s pharmacovigilance processes. 

Pharmaceutical companies must also monitor the local medical literature in the native language of each market and submit ICSRs to databases such as EudraVigilance in the EU, or national safety databases in other regions. These tasks are critical but often become secondary due to limited resources or the belief that pharmacovigilance is a non-core activity—putting both patient safety and business reputation at risk. 

The Importance of Local and Global Expertise in Pharmacovigilance 

Managing pharmacovigilance across borders requires both global oversight and local expertise. While the US has uniform safety reporting requirements across all states, companies entering international markets must tailor their processes to meet the local requirements. This adds another layer of complexity, particularly in regions such as Middle East and Africa (MEA), where some countries like Saudi Arabia, South Africa, and Egypt have well-established PV regulations, while others are just beginning to develop their systems. 

To successfully navigate these diverse regulatory landscapes, pharmaceutical companies must rely on both global PV strategies and local knowledge. It is essential to adopt strategies that allow for standardized ICSR processing while still respecting country-specific requirements. This balance ensures compliance with local regulations and improves the quality and consistency of safety reporting. 

How to Overcome the Challenges: A Hub-and-Spoke Model for Pharmacovigilance 

A practical solution to this complex challenge is adopting a hub-and-spoke model for pharmacovigilance. This model allows companies to globally coordinate ICSR processing with standardized procedures, while simultaneously providing local expertise to address the unique requirements of each market. By having regional or native pharmacovigilance experts in each country, companies can ensure they meet local safety obligations, handle follow-up activities, and ensure compliance with regulations. 

As companies enter new markets, conducting a thorough gap analysis of local regulations and risks is vital. It is also important to ensure that local PV staff are properly trained on country-specific obligations and ready for any potential inspections. 

Outsourcing Local Pharmacovigilance Activities: A Cost-Effective Solution 

Maintaining a robust pharmacovigilance system requires significant resources, particularly when operating across multiple countries. To address this challenge, many companies are opting to outsource local pharmacovigilance activities. This approach not only reduces costs but also provides assurance that local obligations are being met effectively. By outsourcing, companies can focus on their core operations while ensuring compliance with the complex and evolving regulatory landscape. 

How BioBoston Consulting Can Support Your Pharmacovigilance Efforts 

At BioBoston Consulting, we specialize in helping pharmaceutical companies navigate the complex and diverse pharmacovigilance requirements across different regions. Our team of experts provides global oversight with deep knowledge of local regulations, ensuring that your safety reporting processes are compliant and efficient. 

Is your company prepared to meet the growing challenges of global pharmacovigilance? Let BioBoston Consulting help you manage safety reporting, streamline compliance processes, and ensure patient safety. Contact us today to learn how we can support your pharmacovigilance needs.