Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)

The updated Pharmacovigilance Guidance document for Marketing Authorization Holders (MAHs) in India is a crucial step toward enhancing drug safety and ensuring consistent practices across the pharmaceutical industry. Here’s a summary of its key components:

• Pharmacovigilance System: The document outlines how MAHs should establish a robust pharmacovigilance system. This includes defining roles and responsibilities for various authorities involved in monitoring drug safety.
• Pharmacovigilance System Master File (PSMF): MAHs are required to maintain a PSMF, which serves as a comprehensive record detailing:
  • Organizational structure and personnel involved in pharmacovigilance.
  • Sources of safety data, such as clinical trials and post-marketing reports.
  • Processes for collecting, processing, and reporting individual case safety reports (ICSRs).
• Public Comment Period: The document includes a timeline for stakeholders to provide feedback, ensuring that the guidance reflects the input of various parties involved in pharmacovigilance.
• Periodic Safety Update Reports (PSURs): PSURs are critical for ongoing evaluation of a drug’s benefit-risk profile after it has entered the market. These reports must comply with the Drugs and Cosmetics Act, 1940, and the New Drugs & Clinical Trial Rules, 2019, emphasizing the need for continual monitoring of safety and efficacy in real-world settings.
• Importance of Post-Marketing Assessment: The guidance reinforces the necessity of post-marketing studies to track the performance of new drugs, helping to identify any adverse effects or efficacy issues that may not have been apparent during clinical trials.

Overall, this guidance aims to improve drug safety monitoring and promote a culture of vigilance within the pharmaceutical industry in India.

Source: https://cdsco.gov.in/opencms/opencms/en/PSUR_PV_AEFI/

Region: India