VII.B.3. Principles for the preparation of PSURs

Unless otherwise specified by competent authorities, the marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indications, route of administration, dosage forms and dosing regiments, irrespective of whether authorised under different names and through separate procedures. Where relevant, data relating to a particular indication, dosage form, route of administration or dosing regimen, shall be presented in a separate section of the PSUR and any safety concerns shall be addressed accordingly [IR Art 34(6)]. There might be exceptional scenarios where the preparation of separate PSURs might be appropriate, for instance, in the event of different formulations for entirely different indications. In this case, agreement should be obtained from the relevant competent authorities preferably at the time of authorisation.

Case narratives shall be provided in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern [IR Art 34(4)]. In this context, the term “case narratives” refers to clinical evaluations of individual cases rather than the CIOMS narratives. It should not be necessary to provide the actual CIOMS narrative text included in the individual case safety report (ICSR) but rather a clinical evaluation of important or illustrative cases in the context of the evaluation of the safety concern/signal.

When data received at the marketing authorisation holder from a partner might contribute meaningfully to the safety, benefit and/or benefit-risk analyses and influence the reporting marketing authorisation holder’s product information, these data should be included and discussed in the PSUR.

The format and table of contents of all PSURs shall be as described in the IR Art 35 and each report should include interval as well as cumulative data. As the PSUR should be a single stand–alone document for the reporting interval, based on cumulative data, summary bridging reports and addendum reports, introduced in ICH-E2C(R1) guideline, will not be accepted.

The GVP Modules on Product- or Population-Specific Considerations3 should be consulted as applicable when preparing a PSUR.