20 December 2012

The ICH S10 Guideline on Photosafety Evaluation of Pharmaceuticals reached Step 2 of the ICH Process in November 2012 and now enters the consultation period (Step 3).

This new Guideline on photosafety testing will be a valuable adjunct to the guidance provided in the M3(R2) Guideline.

The draft Guideline is now available for download under the Safety Guideline page.

You are invited to provide comments on the draft Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, US and Japan are encouraged to submit their comments to their respective Regulatory Authorities.