English to Romanian Medical Medical: Pharmaceuticals

However, sometimes an effect on efficacy and/or safety can be expected or cannot be ruled out in spite of a state
of the art physico-chemical and biological tests. In such cases, additional non-clinical and clinical
studies will be necessary. The type and extent of such studies are variable and will dependent on
numerous factors related to the drug substance and the drug product, to findings in the comparability
exercise as well as to its clinical use.
This is a sequential process, beginning with quality studies (limited or comprehensive) and supported,
as necessary, by non-clinical and/or clinical bridging studies.
This guideline will address the requirements for non-clinical and/or clinical bridging studies to
demonstrate that the modification has no impact on safety and efficacy profile.

The summary bridging report is a concise document integrating the information presented in two or more PSURs to cover a specified period over which a single report is requested (e.g. 2 consecutive 6-monthly reports for a yearly PSUR, 6 consecutive 6-monthly PSURs, or a combination of 6-monthly and yearly PSURs to make up a 3 year report).
The summary bridging report should include summary highlights bridging two or more PSURs and an overview of data from the attached PSURs to which it refers. The format should be identical to that of the usual PSUR.
The summary bridging report should not include new data or line listings. Moreover, PSUR data should not be repeated, but cross-referred to individual PSURs. However the clinical overview should contain a discussion about safety data as it would be included in such summary bridging report.

The
MAH did however submit a bridging report making reference to the user test results.