ICH Guidelines

ICH Guidelines: Purpose, Participants, and Process

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1. Introduction The pharmaceutical industry is one of the most regulated industries worldwide. Medicines and medical products must be safe, effective, and of high quality before reaching the public. To achieve these goals across diverse regions and regulatory frameworks, a unified approach to drug development and approval is essential. Historically, drug manufacturers had to fulfill … Read more

ICH Guidelines for Pharmacovigilance (PV)

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Pharmacovigilance (PV) is the science and set of activities dedicated to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. To ensure harmonization of drug safety monitoring across countries, the International Council for Harmonisation (ICH) has developed a set of guidelines known as the ICH E2 series, which form the … Read more