• Nonclinical Safety Studies M3

    Code Document Title Previously coded
    • Finalised Guideline:
      June 2009

      Description:

      The recommendations of this revised guidance further harmonise the nonclinical safety studies to support the various stages of clinical development among the regions of European Union (EU), Japan, and the United States. The present guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human clinical trials and marketing authorisation for pharmaceuticals.

      Implementation:

      Step 5

      EU:

      Approved by CHMP June 2009, issued as CPMP/ICH/286/95. Coming into operation in December 2009

      MHLW:

      Adopted on 19 February 2010, PFSB/ELD notification No. 0219-4

      FDA:

      Published in the Federal Register, Vol. 75, No 13, Docket No. FDA/2008/D/0470, p. 3471, 21 January 2010