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


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


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


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


      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website