• Clinical Trials E7 - E11

    Code Document Title Previously coded
    • E11Clinical Investigation of Medicinal Products in the Pediatric Population

      Finalised Guideline:
      July 2000

      E11
      Description:

      The harmonised tripartite Guideline was finalisedunder Step 4 in July 2000. This document addresses the conduct of clinical trials of medicines in pediatric populations. This document will facilitate the development of safe and effective use of medicinal product in pediatrics.

      Implementation:

      Step 5

      EU:

      Adopted by CPMP, July 2000, issued as CPMP/ICH/2711/99

      MHLW:

      Adopted 15 December 2000, PMSB/ELD Notification No. 1334

      FDA:

      Published in the Federal Register, 12 April 2000, Vol. 65, No. 71, p. 19777-81