Author: Mr. Ashutosh Jain
Volume: 01
First Online: 31 August 2024
Pages: 239-259
DOI:

The second part of the ICH guidelines for pharmacovigilance focuses on advanced aspects of drug safety monitoring, including signal detection, risk management, and the integration of real-world evidence. Key guidelines such as ICH E2E on pharmacovigilance planning emphasize proactive risk management through the development of Risk Management Plans (RMPs) for new drugs. ICH E2D and E2F provide frameworks for post-approval safety data management and Development Safety Update Reports (DSURs), ensuring continuous safety evaluation throughout a drug’s lifecycle. These guidelines are crucial for maintaining a drug’s benefit-risk balance and for the harmonization of pharmacovigilance practices globally. By adopting these guidelines, regulatory authorities and pharmaceutical companies can better manage drug safety, protect public health, and respond effectively to emerging safety concerns.