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Periodic Safety Updates

Meaning

Periodic Safety Updates (PSUs), commonly known as Periodic Safety Update Reports (PSURs), are mandatory, highly comprehensive reports meticulously prepared by pharmaceutical sponsors to provide a systematic and critical evaluation of the risk-benefit balance of a medicinal product at defined intervals following its initial marketing authorization. These essential regulatory documents synthesize and analyze all relevant worldwide safety information, including data derived from ongoing clinical trials, spontaneous reports of adverse events, and published scientific literature. The fundamental purpose is to ensure that the continued safety profile of the drug remains acceptable and to facilitate the early detection of any emerging or changing risks. This ongoing, formalized vigilance is a cornerstone of effective post-market drug surveillance and regulatory compliance.