SafetyGlossary Term
ICH E2C(R2)
A comprehensive, periodic assessment of the benefit-risk balance of a medicinal product, submitted to regulatory authorities at defined intervals throughout its lifecycle.
The Periodic Safety Update Report provides a systematic, structured evaluation of a product's safety profile at regular intervals, enabling regulatory authorities to monitor the ongoing benefit-risk balance based on accumulated experience. PSURs integrate safety information from all available sources, including clinical trials, post-marketing surveillance, and the published literature, presenting a comprehensive picture of what is known about the product's risks and the measures in place to manage them. This periodic reporting complements expedited reporting of individual cases by providing aggregate analysis and trend evaluation.
The content and format of PSURs follow international standards established in ICH E2C(R2), which harmonizes requirements across major regulatory jurisdictions. A PSUR includes an executive summary, a description of the worldwide marketing status, an estimate of patient exposure, presentation of aggregate safety data from all sources during the reporting period, analysis of new safety signals and known risks, evaluation of the benefit-risk balance, and conclusions with proposed actions. The report must present a critical analysis rather than merely a compilation of data, providing the sponsor's assessment of the implications of accumulated safety information.
Reporting frequencies depend on the product's development stage and time since approval, with more frequent reporting during early phases when experience is limited and less frequent reporting as the safety profile becomes established. For investigational products, Development Safety Update Reports serve a similar function, providing periodic comprehensive safety assessments during clinical development. Marketing authorization holders must maintain pharmacovigilance systems capable of producing high-quality PSURs on schedule, as late or inadequate submissions may result in regulatory action.
Periodic submission
"The marketing authorization holder submitted the annual PSUR covering the preceding year's safety experience, including analysis of over 5,000 adverse event reports received through the post-marketing surveillance system and an updated benefit-risk assessment."
Signal discussion
"The PSUR included detailed analysis of the potential safety signal for increased myocardial infarction risk identified during the reporting period, presenting the sponsor's assessment of the evidence and proposed additional pharmacovigilance activities."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
ICH E2C(R2)
A comprehensive, periodic assessment of the benefit-risk balance of a medicinal product, submitted to regulatory authorities at defined intervals throughout its lifecycle.
The Periodic Safety Update Report provides a systematic, structured evaluation of a product's safety profile at regular intervals, enabling regulatory authorities to monitor the ongoing benefit-risk balance based on accumulated experience. PSURs integrate safety information from all available sources, including clinical trials, post-marketing surveillance, and the published literature, presenting a comprehensive picture of what is known about the product's risks and the measures in place to manage them. This periodic reporting complements expedited reporting of individual cases by providing aggregate analysis and trend evaluation.
The content and format of PSURs follow international standards established in ICH E2C(R2), which harmonizes requirements across major regulatory jurisdictions. A PSUR includes an executive summary, a description of the worldwide marketing status, an estimate of patient exposure, presentation of aggregate safety data from all sources during the reporting period, analysis of new safety signals and known risks, evaluation of the benefit-risk balance, and conclusions with proposed actions. The report must present a critical analysis rather than merely a compilation of data, providing the sponsor's assessment of the implications of accumulated safety information.
Reporting frequencies depend on the product's development stage and time since approval, with more frequent reporting during early phases when experience is limited and less frequent reporting as the safety profile becomes established. For investigational products, Development Safety Update Reports serve a similar function, providing periodic comprehensive safety assessments during clinical development. Marketing authorization holders must maintain pharmacovigilance systems capable of producing high-quality PSURs on schedule, as late or inadequate submissions may result in regulatory action.
Periodic submission
"The marketing authorization holder submitted the annual PSUR covering the preceding year's safety experience, including analysis of over 5,000 adverse event reports received through the post-marketing surveillance system and an updated benefit-risk assessment."
Signal discussion
"The PSUR included detailed analysis of the potential safety signal for increased myocardial infarction risk identified during the reporting period, presenting the sponsor's assessment of the evidence and proposed additional pharmacovigilance activities."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.