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<p>The spontaneous reporting system for cases of suspected side effects is a&#xa0;central instrument for detecting possible side effects after a pharmaceutical preparation has received marketing authorization. It provides important information (signals) on the occurrence of rare, previously unknown side effects, on increases in the frequency of known side effects that may also be due to quality defects, or on changes in the type or severity of known side effects. In recent decades, this system has made a&#xa0;significant contribution to the identification of drug-related risks that only arise upon widespread use following approval and to the introduction of appropriate measures to minimize risk.</p>

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Arzneimittelsicherheit und Meldepflicht

  • 期刊论文

  • 发表日期：

    2025年9月19日

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  • Christian Behles,
  • Robert Hoffmann,
  • Dennis Lex

摘要

The spontaneous reporting system for cases of suspected side effects is a central instrument for detecting possible side effects after a pharmaceutical preparation has received marketing authorization. It provides important information (signals) on the occurrence of rare, previously unknown side effects, on increases in the frequency of known side effects that may also be due to quality defects, or on changes in the type or severity of known side effects. In recent decades, this system has made a significant contribution to the identification of drug-related risks that only arise upon widespread use following approval and to the introduction of appropriate measures to minimize risk.