Recommendations from Health Canada for the Implementation of ICH Q3D

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The Canadian Authorisation and Monitoring Authority has recently published a notice on its website entitled "Q3D Notice: Health Canada recommendations for implementation of the ICH Harmonised Guideline for Elemental Impurities (Q3D) for new and marketed products". In this notice, Health Canada describes which data are expected in applications for registrations, for new marketing authorisations of medicinal products or OTC products and in variation applications for already marketed products.

Applications submitted after December 31, 2016 will have to include a risk assessment for elemental impurities. This assessment should meet the principles laid down in ICH Q3D i.e. should be oriented towards the training modules developed by the ICH.

In the notice, the Canadian Agency precisely describes the location in the dossier where the data regarding elemental impurities have to be placed:

• The overall risk assessment summary Module 3 under 3.2.P.5.6 Justification of Specifications
• Toxicology data to justify PDE values above the values indicated in ICH Q3D or regarding dosage forms not covered by ICH Q3D in Module 4 under 4.2.3.7.6 Other Toxicity Studies: Impurities.

Module 2 should include a summary of the sections from Module 3 where the information on elemental impurities can be found, namely in 2.3.P.5: Control of Drug Product.

Applications for a new supplemental because of quality-related changes in the manufacture or in the composition of the product (e.g. replacement of an API, starting material, intermediate or an excipient) submitted after December 31, 2016 must include a risk assessment. As of the 1st of January 2018, this assessment should be at inspectors' disposal and all controls set in it should be implemented. The product specification should contain a statement confirming the compliance with ICH Q3D.

If in the assessment the manufacturer comes to the conclusion that batches already on the market could have values of elemental impurities which could possibly endanger public health, then the authority is to be informed immediately. Measures such as product recalls and an action plan to avoid shortages of supply have to be taken, when appropriate.

Regarding OTC products, risk assessments only have to be submitted when the application includes a "Chemistry and Manufacturing" part which is reviewed by the regulatory authority (Therapeutic Products Directorate). Applications without such the risk assessment does not have to be submitted but should be held on file.

Natural health products are exempt from the requirements set in the ICH Q3D Guideline.

Please also see the "Q3D Notice: Health Canada recommendations for implementation of the ICH Harmonised Guideline for Elemental Impurities (Q3D) for new and marketed products" for more detailed information.