🔹 GVP Module VI – Collection, Management, and Submission of Reports of Suspected Adverse Reactions to Medicinal Products

📘 Objective:

To guide Marketing Authorization Holders (MAHs), national competent authorities (NCAs), and sponsors on how to:

• Collect

• Manage

• Evaluate

• Report suspected adverse reactions (ARs) related to medicinal products

🔹 1. Definitions

• Adverse Reaction (AR): A harmful and unintended response to a medicinal product.

• Serious AR: Causes death, is life-threatening, requires hospitalization, causes disability, etc.

• Spontaneous Report: An unsolicited communication by a healthcare professional or consumer describing an AR.

• Solicited Report: Arises from organized data collection (e.g., clinical trials, post-marketing studies).

🔹 2. Collection of Reports

🔹 Sources:

• Spontaneous reports

• Literature

• Internet or digital media

• Studies (e.g., post-authorization safety studies)

• Regulatory authority requests

📝 Key Requirements:

• All suspected ARs must be collected regardless of seriousness or expectedness.

• MAHs must ensure systems are in place to record and process reports effectively.

🔹 3. Validation of Reports

Criteria for Valid Individual Case Safety Report (ICSR):

1. Identifiable reporter

2. Identifiable patient

3. Suspected medicinal product

4. Suspected adverse reaction

If any of these are missing, the case is not valid for submission but should be stored.

🔹 4. Data Management

• Ensure data accuracy, integrity, and completeness

• Standard coding using MedDRA (Medical Dictionary for Regulatory Activities)

• Use of ICH E2B(R2)/E2B(R3) format for electronic reporting

🔹 5. Reporting Timelines

To EudraVigilance:

• Serious ARs: Within 15 calendar days

• Non-serious ARs: Within 90 calendar days

Responsibilities:

• MAHs: Submit all relevant ICSRs

• NCAs: Monitor and ensure compliance

🔹 6. Quality Management

• Implement SOPs for ICSR handling

• Ensure training of personnel

• Conduct regular audits and quality checks

🔹 7. Special Situations

• Pregnancy/breastfeeding reports

• Pediatric and geriatric populations

• Medication errors

• Lack of efficacy

• Off-label use

• Drug abuse/misuse/overdose

Each must be evaluated and reported with appropriate clinical judgment.

🔹 8. Record Keeping

• Retain source documents and reports for at least 10 years

• Maintain traceability and audit trails

🔹 9. Annexes & References

• Annexes provide detailed guidance on:

  • Structure and fields of ICSR

  • Literature monitoring

  • Examples of report types

 Conclusion:

GVP Module VI emphasizes complete, timely, and high-quality adverse reaction reporting as a critical component of pharmacovigilance. It ensures that risks associated with medicinal products are monitored and managed efficiently, safeguarding public health.

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