• Clinical Evaluation by Therapeutic Category E12

    Code Document Title Previously coded
    • E12Principles for Clinical Evaluation of New Antihypertensive DrugsE12A

      Finalised Document:
      March 2000

      E12
      Description:

      This therapeutic area document considers the Clinical Evaluation of New Antihypertensive Drugs. It provides a set of "Principles" on which there is general agreement among all three ICH regions covering endpoints and trial designs. Since there are a few differences in the requirements of the three regions that have not been harmonised, this document should be considered an "ICH Principle Document" rather than an "ICH Guideline". It will not be subject to the usual procedures leading to a fully harmonised document.

      Implementation:

      Step 5

      EU:

      Released for information, June 2000, issued as CPMP/ICH/541/00

      MHLW:

      Released for consultation, 29 May 2000, PMSB/ELD Notification No. 738

      FDA:

      Released for consultation, 9 August 2000, published in the Federal Register, Vol. 65, No. 154, p. 48720-21