Translation of "Periodic Safety Update Report " (English → French) :

Periodic Safety Update Report | PSUR [Abbr.]

single agent PSUR | single periodic safety update report | single PSUR | single-substance periodic safety update report | single-substance PSUR

Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

safety update reports for marketed drugs

The provisions applicable to the submission of periodic safety update reports laid down in the second subparagraph of Article 107c(2) of that Directive shall apply to holders of marketing authorisations which were granted before 2 July 2012 and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation until such time as another frequency or other dates of submission of the reports are laid down in the marketing authorisation or are determined in accordance with Article 107c of that Directive.

We provide a periodic summary to be provided to the regulator in the form of the periodic safety update reports.

After a pharmaceutical is authorized for sale in Canada, Health Canada monitors its safety by evaluating reported adverse drug reactions, reviewing periodic safety update reports and analyzing information gathered from various sources, such as medical and scientific literature, other regulatory agencies internationally and manufacturers.

The regulatory submissions from industry, such as risk management plans or periodic safety update reports, use internationally harmonized formats that both facilitate our discussions with international regulators and reduce the burden for industry.