• S10 Photosafety Evaluation

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2013

      Description :

      The tripartite harmonised ICH Guideline reached Step 4 of the ICH process on 13 November 2013.

      This Guideline provides international standards for photosafety assessment and harmonises such assessments supporting human clinical trials and marketing authorizations for pharmaceuticals. It includes factors for initiation of and triggers for additional photosafety assessment and should be read in conjunction with ICH M3(R2), Section 14 on Photosafety Testing.

      Implementation :

      Step 5

      EC :

      Adopted by CHMP December 2013, issued as EMA/CHMP/ICH/752211/2012

      MHLW/PMDA :

      Adopted May 2014, PFSB/ELD Notification No. 0521-1

      FDA :

      Published in the Federal Register, 26 March 2015, Vol. 80, No. 17, Docket No. FDA/2013/D/0068, p. 4282-3

      Health Canada :

      Implemented 22 January 2016, File #: 15-114073-949

      Swissmedic :

      Please refer to the press release on Swissmedic’s website for information on implementation