Summary Bridging Reports

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Chapter: Pharmacovigilance: Periodic Safety Update Reports

The different frequency and periodicity requirements of different regulatory authorities in different coun-tries create potential problems for the production of PSURs.


SUMMARY BRIDGING REPORTS

The different frequency and periodicity requirements of different regulatory authorities in different coun-tries create potential problems for the production of PSURs. Under ICH E2C provisions, regulators who do not wish to receive 6-month report are expected to accept two 6-month reports as an annual report or the appropriate series of reports as a 5-year report. CIOMS V therefore proposed the use of the summary bridging report to facilitate the review of a series of reports. This is a concise document integrating the information presented in two or more PSURs that is submitted to a regulatory authority to cover a spec-ified period over which a single report is required. It should not contain new data or repeat the infor-mation already included in the PSURs but should cross-reference those other reports. The format/outline should be identical to the format of the usual PSUR but the content should consist of summary highlights. The summary bridging report ordinarily should not contain line listings; however, a summary tabulation of serious, unlisted ADRs should be included if the regulatory authority requests it.

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