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New ICH Guideline Marks Turning Point In Supporting Multi-Regional Pediatric Development

 
• By Vibha Sharma

A new high-level draft ICH guideline issued is expected to reduce the likelihood of substantial differences among regions regarding acceptance of data generated in pediatric global drug development.

A new draft guideline issued by the International Council for Harmonisation to further support pediatric drug development is being regarded as an “important turning point for the benefit of children" because of its potential to affect a wide range of issues, such as regulatory convergence, drug development strategies, approach to R&D and designing of pediatric trials.

The draft guideline, on which stakeholder comments are being invited, is an addendum to the existing ICH E11 guidance on "Clinical Investigation of Medicinal Products in the Paediatric Population" that...

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