Article | September 4, 2024

Understanding The PSUR And PBRER

Source: ProPharma
GettyImages-849207658 Drug toxicity concept

Periodic Safety Update Reports (PSURs) are crucial for monitoring the ongoing safety and efficacy of medicinal products after they have been approved and are available on the market. While initial clinical trials provide valuable information about a drug's effectiveness and safety, these trials typically involve a limited number of participants and may not include certain higher-risk subgroups. Consequently, the full extent of a drug's safety profile often remains uncertain until it is used by a larger, more diverse population.

PSURs bridge this gap by continuously analyzing real-world data to identify rare adverse reactions, evaluate safety in special populations, and assess long-term effects. These reports ensure that any emerging safety concerns are promptly addressed and that the benefit-risk balance of the drug is continually reassessed. This blog will explore the importance of PSURs, their evolution into Periodic Benefit-Risk Evaluation Reports (PBRERs), and their critical role in safeguarding public health.

To understand their significance, let’s delve into the background of PSURs and their role in maintaining the safety and efficacy of medicinal products throughout their lifecycle.

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