The European Medicines Agency (EMA) plays a crucial role in ensuring the safety and efficacy of medicines throughout their lifecycle. Through pharmacovigilance inspections, the agency assesses the systems pharmaceutical companies have in place to detect, assess, understand, and prevent adverse events associated with their products. While the detailed findings of individual inspections are confidential, EMA publishes anonymized trends and recurring issues in their annual pharmacovigilance reports.

Based on the latest report for 2023 [1], here are some key post-marketing safety issues identified by EMA during inspections:

1. Data Quality and Completeness:
   • Substandard Reporting: Inspections revealed instances where companies were:
     • Under-reporting suspected adverse reactions (ADRs), potentially masking potential safety concerns.
     • Failing to report ADRs within the stipulated timeframe, hindering timely evaluation and potential risk mitigation measures.
     • Submitting inaccurate or incomplete data, making it difficult to assess the true safety profile of the medication.
2. Risk Management Plans (RMPs):
   • Inadequate development: RMPs, crucial documents outlining strategies to identify, assess, and minimize risks associated with a medicine, were found to be:
     • Lacking proper detail and justification for the selected risk mitigation strategies.
     • Failing to incorporate the latest available safety information, potentially overlooking emerging safety concerns.
   • Inadequate development: RMPs, crucial documents outlining strategies to identify, assess, and minimize risks associated with a medicine, were found to be:
   • Ineffective implementation and maintenance: Companies were observed to be:
     • Allocating inadequate resources for implementing and maintaining RMPs, hindering their effectiveness.
     • Not conducting regular reviews and updates to the RMPs, failing to adapt them to evolving risks.
3. Signal Detection and Management:
   • Inefficient processes: The report highlighted deficiencies in how companies:
     • Identify potential safety signals from diverse sources like spontaneous reports (direct reports from patients or healthcare professionals), clinical trials, and scientific literature. These signals might indicate potential safety issues requiring further investigation.
     • Investigate and escalate potential safety signals in a timely manner, potentially delaying crucial risk identification and mitigation actions.
     • Take appropriate actions based on identified signals, such as conducting further studies or revising product information.
4. Pharmacovigilance System Deficiencies:
   • Organizational shortcomings: These included:
     • Unclear organizational structures lacking designated personnel and clearly defined responsibilities for pharmacovigilance activities, leading to potential confusion and inefficiencies.
     • Inadequate training and expertise of personnel involved in pharmacovigilance, raising concerns about their ability to effectively manage and analyze safety data.
   • Quality management system deficiencies: Companies were found to have:
     • Inadequate quality management systems to oversee pharmacovigilance processes, potentially compromising data integrity and reliability.

• Addressing the Issues:
  • The EMA report emphasizes the need for pharmaceutical companies to take proactive measures to address these recurring concerns. This includes:
  • Investing in robust data collection and reporting systems to ensure accurate and timely reporting of ADRs.
  • Strengthening RMP development and implementation by involving relevant experts, incorporating the latest safety information, and allocating adequate resources.
  • Establishing efficient processes for signal detection, evaluation, and follow-up to ensure timely investigation and appropriate actions.
  • Ensuring adequate staff training and resource allocation for pharmacovigilance activities, including ongoing professional development and access to necessary tools and technologies.
  • Implementing robust quality management systems to guarantee the integrity and reliability of pharmacovigilance processes.
  • By taking these steps, pharmaceutical companies can significantly improve their pharmacovigilance practices, contributing to the safety of patients using their medicines.
• Reference:
  • [1] European Medicines Agency. "The European medicines agency pharmacovigilance report 2023." https://www.ema.europa.eu/en/news/human-medicines-highlights-2023