Post-Market Drug Safety: Global Pharmacovigilance Systems

 



The journey of a medicinal product continues long after approval. Once a drug reaches the real world, its true safety profile begins to emerge. Post-market pharmacovigilance (PV) ensures that every patient experience contributes to understanding the product’s benefits and risks in diverse, uncontrolled environments. This ongoing process is the foundation of public health protection.

Traditionally, Individual Case Safety Reports (ICSRs) have served as the backbone of post-market safety surveillance. These reports, submitted by healthcare professionals, patients, and manufacturers, provide critical insights into adverse events (AEs). However, the landscape is evolving. With the growth of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) technologies, the integration of Real-World Data (RWD) now complements and strengthens conventional reporting systems.

RWD, sourced from electronic health records (EHRs), wearable devices, patient registries, insurance databases, and digital health platforms, offers a broader and more dynamic understanding of medicine use in actual clinical practice. This shift enables regulators and Marketing Authorization Holders (MAHs) to detect safety signals faster and contextualize them with deeper patient insights.

Core Elements of Post-Market Drug Safety

Post-market safety focuses on identifying, assessing, and mitigating risks that may not have been fully evident during clinical trials. The following key components define the pharmacovigilance process after product launch:

Adverse Event Detection and Reporting

Capture initial safety signals from real-life settings

Spontaneous reports from healthcare providers or patients, automated submissions, literature reviews, and regulatory databases

Case Processing (ICSR Handling)

Collect, validate, and assess reported cases

Triage, data verification, MedDRA coding, assessment of seriousness and causality, and follow-up when required

Data Management and Standardization

Ensure quality and consistency across systems

Apply ICH E2B(R3) format, MedDRA and WHO-DD terminology, and implement duplicate detection and data cleaning

Signal Detection

Identify potential new or changing risks

Statistical methods such as PRR, ROR, trend, and cluster analysis using ICSRs and complementary datasets

Signal Validation and Prioritization

Evaluate clinical significance and public health relevance

Assess biological plausibility, frequency, severity, and affected populations

Risk Assessment and Quantification

Characterize risk magnitude

Perform epidemiological studies, subgroup analysis, and incidence estimation using RWD

Risk Management and Mitigation

Implement safety measures

Update product labeling, communicate with healthcare providers, and initiate PASS or REMS programs

Continuous Monitoring

Maintain oversight throughout the product lifecycle

Conduct ongoing signal detection, reassess risk management plans, and apply audit findings to strengthen systems

Read more here: Post-Market Drug Safety: From ICSRs to Real-World Data Integration in Global Pharmacovigilance Systems — DDReg pharma

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