EMA To Consider How To Deliver Drug Risks Information Via Digital Formats
Electronic Distribution Of Education Materials Cannot Substitute Paper Materials
European Medicines Agency plans to finalize changes to its guideline on additional risk minimization measures and then establish a new drafting group on digitalization of education materials.
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Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.
Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.
Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.