The MHRA's Good Pharmacovigilance Practices (GPvP) Inspection Programme is a critical regulatory mechanism designed to ensure that Marketing Authorisation Holders (MAHs) meet pharmacovigilance requirements and maintain the safety of medicinal products in the UK. This inspection programme is organized into four distinct arms—each focusing on different aspects of risk management, safety reporting, and compliance monitoring.

In this blog, we explore the latest guidelines, key focus areas, and insights from the 2024 GPvP symposium, which shed light on the evolving challenges and priorities in ensuring pharmacovigilance compliance.

The Four GPvP Inspection Arms

The GPvP inspection programme is structured around four inspection arms, each addressing specific facets of pharmacovigilance to provide a comprehensive view of MAH compliance.

1. Routine Pharmacovigilance Activities

Objective: To assess whether the MAH can identify, characterize, and report new or evolving risks associated with their medicinal products.

Key focus areas include:

• Management of Individual Case Safety Reports (ICSRs) from spontaneous and solicited sources
• Periodic safety updates and signal management
• Compliance with regulatory requirements (e.g., QPPV supervision, audits)

In the latest inspections, the MHRA identified critical deficiencies in signal management and the maintenance of Reference Safety Information (RSI). These findings highlighted delays in updating safety data and issues with safety signal prioritization, which could potentially affect patient safety. MAHs need to ensure real-time data monitoring and proper oversight of pharmacovigilance operations to avoid these pitfalls.

2. Routine Risk Management and Safety Communication

Objective: To assess whether safety updates have been effectively communicated to healthcare professionals and patients.

Key focus areas include:

• Maintenance and timely updates of reference safety information
• Implementation of approved safety changes in product information
• Safety communication strategies, including direct healthcare professional communications (DHPC) and educational materials

The MHRA highlighted significant delays in aligning UK-licensed product safety information with updates from the EMA. This resulted in critical findings, particularly where failures to update RSI led to communication gaps, potentially impacting patient outcomes. Ensuring that safety information is timely and accurate is crucial for maintaining trust in the product’s safety profile.

3. Additional Risk Minimisation Activities (aRMMs)

Objective: To assess whether aRMMs are being implemented in accordance with the agreed risk management plan (RMP).

Key focus areas include:

• Tailored risk management systems for high-risk products
• Implementation of controlled access and pregnancy prevention programmes

Inspections revealed challenges in managing additional risk minimization measures (aRMMs), with many MAHs failing to fully implement these activities. The MHRA emphasized that aRMMs must be tailored to specific products and population risks. In some cases, controlled access programs were inadequately monitored, leading to significant critical findings.

4. Non-Interventional Post-Authorisation Safety Studies (NI-PASS)

Objective: To assess whether NI-PASS are conducted in line with approved study protocols and whether safety data is appropriately reported.

Key focus areas include:

• Study-specific inspections of UK investigator sites
• Adherence to protocols for real-world data collection and safety reporting

NI-PASS studies are becoming an increasing focus in inspections, with many triggered inspections in 2024 reviewing compliance with post-market safety monitoring protocols. In some cases, there were concerns regarding delayed reporting of long-term safety data, which could affect the broader risk-benefit evaluation of the medicinal product.

Key Insights from Recent MHRA Inspections

The 2024 GPvP symposium provided valuable insights into the MHRA's current inspection strategies and trends:

• Reduced Number of Inspections: The total number of inspections dropped from 32 in 2021/2022 to 17 in 2022/2023, although the average inspection duration remained consistent at 9 days. This reflects a more targeted approach to inspections, focusing on high-risk areas.

• Remote Compliance Assessments (RCA): A new Remote Compliance Assessment (RCA) pilot was introduced, streamlining the re-inspection process for MAHs with limited or specific findings. The RCA allows inspectors to conduct document-based reviews without the need for full on-site re-inspections, saving both time and resources.

• Common Critical Findings: Signal management, risk communication, and aRMMs continue to drive critical findings, emphasizing the need for MAHs to enhance real-time safety data oversight and streamline communication processes.

• AI and Technology in Pharmacovigilance: The symposium also addressed the potential of artificial intelligence (AI) in pharmacovigilance, with 27% of surveyed organizations already using AI for tasks like adverse event collection. However, AI's role in safety reporting is still evolving, and no AI systems have yet undergone MHRA inspection.

The MHRA's GPvP inspection programme remains a cornerstone of pharmacovigilance compliance in the UK, focusing on high-risk areas such as signal management, RSI updates, and additional risk minimization measures. With new initiatives like Remote Compliance Assessments (RCA) and growing attention on NI-PASS, MAHs must stay ahead of evolving regulatory expectations.

By proactively addressing the insights from recent inspections, particularly in managing real-time safety data and streamlining communication pathways, MAHs can not only avoid critical findings but also ensure the safety and efficacy of their products in the post-market environment.

To stay compliant, it is essential for MAHs to maintain a robust Quality Management System (QMS) and Pharmacovigilance (PV) database and be prepared for both routine and triggered inspections.

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Sources:

1. MHRA Inspectorate
2. Good Pharmacovigilance Practice (GPvP) Guidelines - GOV.UK