Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) 

October 30, 2017
Our file number: 17-109365-631

A final version of the following Guidance Documents and template are now available:

• Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
• ADDENDUM - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
• Glossary of Quality Terms
• Certified Product Information Document Guidance Document
• CPID-CE Template

Comments and suggestions received from the consultation between August 31, 2016 and October 7, 2016 on the draft version of the guidance were reviewed and considered in the finalization of this document. The results of this consultation are available by email on request to: bps_enquiries_enquetes_bsp@hc-sc.gc.ca

The guidance outlines guidance for industry and staff regarding the submission of information for marketing authorisation of new drugs pursuant to the Food and Drugs Act and Food and Drug Regulations.

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

Date of publication of final guidance: October 30, 2017

Date of implementation for General Quality Guidance: January 30, 2018

Significant new requirements are presented in the guidance document (i.e. stability studies on three batches of product for existing drugs, commercial scale batches and pilot batch sizes for certain products). The product development cycle may take several years, including the generation of the data to support submissions. In order to take this into account a phased in approach over a period of 1-2 years has been set for two sets of requirements. This timeframe is necessary to allow companies sufficient time to plan, procure and/or manufacture and test new batches of the Active Pharmaceutical Ingredient (API) and drug product, as well as implement infrastructure changes, for example, expand capacity of stability chambers, storage.

New Stability Requirements for Existing Drugs: Full implementation October 30, 2019

Staged implementation:

As of October 30, 2017, the Sponsor Attestation Checklist for ANDSs will be revised to request confirmation whether stability data on at least 3 primary batches have been submitted.

After October 30, 2019, the regulatory project manager will issue a Screening Deficiency Notice if a submission does not contain at least 6 months of stability data on at least 3 primary batches of the drug substance and drug product. The Sponsor Attestation Checklist for ANDSs will be revised at this time to confirm that 3 batches have been submitted.

New Requirements for Executed Batches to be Manufactured at Commercial Scale Batch Size and pilot scale for liquid products: October 30, 2019

Staged implementation:

As of the October 30, 2017, 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 at this time to confirm that a commercial scale batch has been submitted or justification for the size of the executed batches has been provided.

Should you have any questions or comments regarding the content of the guidance, please contact the Bureau of Pharmaceutical Sciences by email at bps_enquiries_enquetes_bsp@hc-sc.gc.ca.

Bureau of Pharmaceutical Sciences
Therapeutic Products Directorate
Health Canada
Address Locator 0201D
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-7350
Facsimile: 613-957-3989