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Final ICH Addendum Offers Latest Perspectives On Pediatric Drug Development

 
• By Vibha Sharma

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

Toy dog
ICH’s High-Level Document Addresses Pediatric Trial Issues • Source: Shutterstock

The International Council for Harmonisation has finalized a high-level document to complement and further clarify its E11 guideline on the clinical investigation of medicinal products in the pediatric population.

The new document, E11(R1), has been issued as an addendum to the guideline, which has been in place since July 2000. It reflects the progress in pediatric development...

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