3 June 2018

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.

The ICH Q3D(R1) Revision is focused on an error correction in the calculation of the Cadmium inhalation Permitted Daily Exposure (PDE) level. The Expert Working Group re-evaluated the data supporting the Cadmium inhalation PDE and concluded that a modifying factors approach, similar to that used for calculating the oral and parenteral PDEs, was appropriate for the inhalation PDE.

The ICH Q3D(R1) draft Revision can be downloaded on the Quality page on the ICH website.

You may provide comments on the ICH Q3D(R1) draft Revision document by e-mailing the ICH Secretariat. More details under the Public Consultation page.

Note that stakeholders from ICH Regions are encouraged to submit their comments to their respective Regulatory Authorities.