The ICH Q3D(R2) Draft Guideline Available Now on the ICH Website

On 25 September 2020 the ICH Q3D(R2) draft guideline on elemental impurities reached step 2 of the ICH process.

The extracts with the amendments to the ICH Q3D(R2) draft Guideline for Elemental Impurities, which show the revisions to Appendix 2 and 3 further to corrections of the Permitted Daily Exposure (PDEs) for Gold, Silver and Nickel as well as a new Appendix 5 on Limits for Elemental Impurities by Cutaneous and Transcutaneous Route, reached Step 2b of the ICH Process in September 2020 and now enters the consultation period.

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