top of page

Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities

Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized Guideline for Elemental Impurities for Dermal and Transdermal Products.


Submissions received by Health Canada after December 31, 2022 should include an elemental impurity risk assessment for dermal and transdermal products in addition to products intended for oral, parenteral and inhalation routes of administration.

Also, submissions received after December 31, 2022 that does not include a risk assessment will need to submit the missing information. Detailed risk assessments and supporting data should be documented and available upon request from the regulator.


The locations of elemental impurity information in Module 3 should be clearly summarized in Module 2.3.P.5: Drug Product Control of the Overall Quality Summary.


The overall summary of the elemental impurity risk assessment should be placed in Module 3.2.P.5.6, Rationale for Specifications. The risk assessment for the container-closure system may contain a reference to a master file.


If toxicological data are submitted to support limits exceeding the permissible daily exposure established in the ICH Q3C guideline or for routes of administration not provided for in the ICH Q3D (R2) guideline, they should be placed in module 4.2.3.7.6, Other toxicological studies: impurities.


Click this LINK to know more about the Health Canada's Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized Guideline for Elemental Impurities for Dermal and Transdermal Products.


Commenti


bottom of page