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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