European Commission: ICH guideline E2F - Note for guidance on development safety update reports

The ICH guideline E2F gives sponsors guidance as to how to draw up the yearly safety report (Article 17(2) of the \'Clinical Trials Directive\' 2001/20/EC). To give additional support, ICH has established \'model DSURs\' which are accessible here. These \'model DSURs\' take account of the differing knowledge about a medicine, depending on whether the sponsor holds the marketing authorisation or not.