Challenges and Future of Pharmacovigilance (PV) Compliance​

In this regard, the HAs have an obligation to ensure guidance and regulations are enacted to govern Market Authorization Holders and ensure they understand implications of noncompliance with pharmacovigilance compliance obligations that could result in potentially serious public health concerns and legal ramifications.

The purpose of expedited AE reporting is to make regulators, investigators, and other appropriate stakeholders to be aware of the latest and important updated information about the serious adverse drug reactions (ADRs). Therefore, such reporting will generally involve events that were previously unobserved or undocumented, and a guideline is required in order to define an event as “unexpected” or “expected” (expected/unexpected from the perspective of previously observed, and not on the basis of what might be anticipated from the pharmacological properties of a medicinal product).⁷

The PSRs are an important PV compliance document that provides an opportunity for MAHs to review the safety profile of their products and ensure that the Summary of Product Characteristics and Patient Information Leaflet are up to date. They also provide HAs with a valuable source of consolidated safety data. Due to these reasons, HAs emphasize on compliance with periodic reporting including submission timeliness, report format, comprehensiveness, completeness, and quality report.¹ In addition, the MAH has to ensure that the comments received from the HA assessor of periodic reports have been adequately addressed in the response document and in the subsequent report. There has to be a mechanism implemented by the MAH to track HA assessment reports and quality reviews to ensure the assessor’s comments have been addressed in the subsequent version.

Among the many challenges in pharmacovigilance today are global regulatory divergences, increasing data complexity and system integration.

Over time there has been an increase in the volume, type, and source of safety data collected during the life cycle of the product. This has resulted in the need for diversified systems to capture and store this information. Furthermore, the current landscape has evolved into a globalized and highly decentralized environment, challenging existing systems, data storage, monitoring, and auditing. Companies must develop more reliable, proactive systems to support PV compliance and easy follow-up mechanisms for managing and tracking data received from various sources of spontaneous reports, clinical trials, other solicited reports, literature publications, patient support programs, market research studies, and HA reports including EMA EudraVigilance database.

Compliance with the latest regulations such as the E2B (R3) and Identification of Medicinal Products are in the various stages of being mandated across different International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions. Business growth into new markets necessitates the PV systems and processes to scale smoothly and sufficiently. Ensuring that existing PV systems and applications constantly evolve to support the business effectively is an important requirement. These evolving regulations affect PV operations at multiple levels and highlight the need for robust pharmacovigilance compliance systems. Many have fundamental implications for the underlying database structure, configurability, reporting capability, and integration with other systems and data sources. Inadequate support for novel and evolving regulations can result in potential regulatory noncompliance and associated penalties. In addition, reporting in the non-ICH regions is even more challenging as the requirements vary more widely than among ICH countries.

Some of the key challenges faced by the PV-IT support include issues associated with the integration of applications and sharing of data between siloed applications as well as availability and scalability of applications. Poor scaling and performance issues lead to system breakdowns resulting in unavailability of mission-critical systems to business users thereby affecting business. Lack of application integration warrants manual intervention, which can result in data inconsistencies and inefficiencies. Moreover, many of the legacy systems are typically not up to date with the latest IT technologies and standards. This can result in potential data security and privacy issues. Managing IT vendor relationships, especially with non-responsive vendors, can be another challenge with stretched timelines for implementation of new features, forcing PV teams to figure manual workarounds or use external consultants for customizations - resulting in expensive and unmanageable systems.

Digitalization, automation, and AI will significantly shape the future of pharmacovigilance compliance in the coming decade.

To understand leadership perspectives on PV compliance, explore inside the minds of PV leaders.

Transforming PV compliance

Tracking implementation status, gathering and interpreting data, and working across boundaries are key pharmaceutical compliance activities that impact multiple functions, from risk management planning to vendor relationships. Many organizations use generic tools to manage PV compliance -related activities. They track the large volume of data using the following three methods:

Within PV and regulatory compliance, pharma companies are constantly dealing with a growing influx of changes – more data from more sources, more products in more locations, and constantly changing reporting requirements. Each change has a cascading impact on other parts of the organization. Businesses need Regulatory Information Management and PV orchestration tools supported by knowledgeable technology partners, who can understand the industry and help companies include and make sense of massive amounts of data while also navigating a complex and ever-evolving regulatory environment. The MAH is actively looking for ways to reduce the growing PV costs and lower the possibility of human errors in PV tasks.⁴ Automation is a vital element that can help businesses to achieve both goals through the use of tools that help in achieving the following points:

Technology will support PV and regulatory compliance processes in ways that were not comprehensible a decade ago, which will be vital to the success of all pharma companies. There are not enough people with sufficient skills and bandwidth to manage all the data that needs to be processed, sorted, and shared. Technology will support the evolution of the structure of the pharma industry workforce and changing roles within the industry.

This aligns with broader trends discussed in our report on Shaping the Future of Pharmacovigilance.

Expect that more than 80% of the top 100 pharma companies will initiate a re-examination of their safety platforms and supporting technologies in the next few years. This is due to the increased volume of AEs and pressure from businesses to lower their costs through automation process. The vast majority of the top 100 to 200 pharma companies will engage in automation projects. The industry is recognizing their aged, inflexible technology cannot meet the growing needs for AI in pharmacovigilance and future of pharmacovigilance readiness.⁴

Ensuring pharmacovigilance compliance is no longer just a regulatory checkbox, but a strategic necessity. And the conventional approaches in monitoring PV compliance have been challenging to manage as they require a lot of manpower. It also leads to huge turnaround time. Automating this space is expected to produce better results around visibility, accessibility, data accuracy, with reduced resource dependability. Automation is likely to reduce effort by more than 80% and decrease cost by at least 50%, making it essential to the future of pharmacovigilance. At the same time, it will improve the accuracy, quality, and consistency of AE data⁶.

For more insights into compliance challenges, read our Q&A with Outsourcing Pharma on PV compliance expectations.