Author: Mr. Abu Tahir
Volume: 01
First Online: 31 August 2024
Pages: 211-238
DOI:

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides comprehensive guidelines for pharmacovigilance, aimed at ensuring the safety and efficacy of medicinal products across different regions. These guidelines harmonize the practices of drug safety monitoring, reporting, and risk management among member countries, facilitating global collaboration in pharmacovigilance activities. Key guidelines include ICH E2E on pharmacovigilance planning, which outlines the development of Risk Management Plans (RMPs) and proactive safety monitoring; ICH E2B, which standardizes the electronic transmission of individual case safety reports (ICSRs) to ensure consistent and accurate reporting; and ICH E2C, which provides guidance on the periodic safety update reports (PSURs) necessary for continuous assessment of a drug’s risk-benefit profile. The ICH guidelines emphasize a systematic approach to detecting, evaluating, understanding, and preventing adverse effects, fostering global public health protection. By adhering to these guidelines, pharmaceutical companies and regulatory authorities can maintain high standards of drug safety and contribute to the harmonization of pharmacovigilance practices worldwide.