Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.
Statistical analysis of signals picked up in large databases of spontaneous reports can help identify disproportionate reporting. However, it may not indicate a need for further investigation, according to the draft. Further, the frequency at which drugmakers should compile and review statistical reports may vary depending on the drug, its use and known risks, it adds.
For a signal to become validated, all relevant documentation must suggest a new potentially causal relationship or new aspect of a known association that justifies further evaluation, the draft states.
The document discusses requirements for managing signal detection and is one of seven good pharmacovigilance practice modules aimed at preparing drugmakers for new pharmacovigilance legislation (Directive 2010/84/EU) that takes effect July 1.
The EU has published what has been described as the largest transformation covering pharmacovigilance in more than a decade.
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