The EMA has invited comments on the new ICH-E2C guideline on periodic safety reporting. The periodic safety report on marketed medicinal products maintains the old reporting timeframe, with the IBD (international Birth Date) to be taken as a starting point. The main difference probably lies in the growing demand for Companies to evaluate more deeply the benefit/risk profile of their drugs since the date of marketing authorisation. With recognition that the assessment of the risk of a medicine is most meaningful when considered in light of its benefits, the proposed revised guideline on PBRER provides greater emphasis on benefit, particularly when risk estimates change significantly. In such cases there will need to be an overall explicit evaluation of benefit-risk. Consequently the name of the proposed report is the ‘periodic benefit-risk evaluation report’.
Summary Bridging Reports and Addendum Reports, introduced in ICH guideline E2C(R1), should no longer be submitted. Regardless of the duration of the interval covered, each report should include interval data for the period covered, as well as cumulative data. PBRER will need synchronisation with the DSUR whenever a drug undergoes further clinical studies after obtaining marketing authorisation.
The PBRER would also provide greater emphasis on the cumulative knowledge regarding a medicine, while retaining a focus on new information. Stakeholders are requested to provide comments using the following form:
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004016.doc