Final ICH Addendum Offers Latest Perspectives On Pediatric Drug Development
A new document that complements the International Council for Harmonisation's existing guideline on pediatric clinical trials is expected to reduce the likelihood of significant differences among countries on the acceptance of data generated in pediatric global drug development programs
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The pharmaceutical industry is cautiously optimistic about the ambitious three-year timeline decided by the International Council for Harmonisation for its new guideline on pediatric extrapolation. However, ensuring consensus on this fast-developing concept will be a challenge as more regulators will have a seat at the discussion table as ICH expands.
The European pharmaceutical industry trade group, EFPIA, is concerned about new requirements proposed in a draft European Commission guideline about how sponsors should prepare and test information materials used for obtaining informed consent from minors participating in clinical trials. It has, however, welcomed proposed changes on the use of a “staggered approach” to recruiting minors into trials.
The International Council for Harmonisation took several key decisions at it latest meeting in Canada, such as developing a new dedicated guideline on extrapolation, admitting a group representing the world's leading pharmaceutical inspectorates as an observer, and adopting revised rules and procedures to ensure the ICH remains ‘agile’ as it grows.