As of 1 September 2011, sponsors of clinical trials must comply with the new clinical trial safety reporting requirements set out in the International Conference on Harmonisation (“ICH”) E2F Guideline on Development Safety Update Reports (“Guideline”).
The Guideline was adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) in September 2010 and is explicitly referred to in the European Commission’s recently adopted CT-3 guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use.
The Guideline is aimed at harmonizing annual safety reporting requirements, in particular with regard to the scope, content and schedules for the submission of safety information. Going forward, sponsors of clinical trials will have to prepare a single Development Safety Update Report (“DSUR”) for each investigational medicinal product, with data for all indications, populations and dosage forms, instead of the previous Annual Safety Report.
The intended scope of the DSUR is wider than the Annual Safety Report, and all safety issues discovered during the reporting period must be discussed, including relevant information from post-marketing studies. The DSUR must also include a summary of important identified and potential risks, in the form of a cumulative, issue-by-issue list, which could form the basis for the development of the risk management plan for the product.
In light of the high level of detail of the Guideline, the new information that must be included in the DSUR, and the possible implications thereof for risk management plans, and potentially the labeling of medicinal products, sponsors of clinical trials and other stakeholders should familiarize themselves with the Guideline as soon as possible, if they have not already done so.