Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc.

On October 30, 2017, Health Canada released the final version of the Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions  (“NDS”) and Abbreviated Drug Submissions (“ANDS”).

The Guidance Document creates several new requirements, in particular the requirement for stability studies for three batches of product for existing drugs, as well as commercial scale batches and pilot sized batches for other products. These requirements are reflected in amendments to the Sponsor Attestation Checklist for ANDSs which request stability confirmation for stability data for three primary batches. After October 30, 2019, the regulatory project manager will issue a Screening Deficiency Notice if a submission does not contain at least six months of stability data on at least three primary batches of the drug substance and drug product. The Sponsor Attestation Checklist for ANDSs will be revised at that time to confirm that three batches have been submitted.

The Guidance Document also sets out new requirements for executed batches to be manufactured at commercial scale batch size and pilot scale for liquid products. Subsequently, the Sponsor Attestation Checklist for ANDSs will be revised to list types of products considered high risk and to request confirmation whether a commercial scale batch or a pilot scale batch meeting the criteria has been submitted. After October 30, 2019, the regulatory project manager will issue a Screening Deficiency Notice if an NDS or ANDS does not contain a commercial scale batch of the drug product identified as a high-risk of having quality issues or an appropriate pilot scale batch for liquids. The Sponsor Attestation Checklist for ANDSs will be revised to confirm that a commercial scale batch has been submitted or justification for the size of the executed batches has been provided.

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Reference:

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-document-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.pdf