Consultation on the Health Canada Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

The Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) outlines the policy and guidance for industry and staff regarding the regulation of new drugs pursuant to the Food and Drugs Act and Food and Drug Regulations.

This current guidance document applies to NDSs and ANDSs for drug substances of synthetic or semi-synthetic origin and their corresponding products, excluding Biotechnological/Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs, which are filed with Health Canada pursuant to Division C.08 of the Food and Drug Regulations. It can also be used as guidance on the requirements for related drug submissions (e.g. SNDSs, SANDSs, Post-NOC Changes).
A draft version of this guidance document was released for consultation in January 2014.  Comments from stakeholders have been considered in the development of this updated draft version.

How to get involved

This consultation is open for comment until December 4, 2016. Please read through the information provided and select the appropriate links below. Please submit your comments via email, fax or by mail to the address below.

Quality (Chemistry and Manufacturing) Guidance: NDSs and ANDSs

This guidance document will supersede the previous draft versions of Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) dated July 18, 2001 and September 19, 2013, as it has been significantly updated in content.

Changes in the content of this draft revision include updates to:

1. Add an addendum for Questions and Answers.
2. Update the guidance document as a result of the 2014 consultation.
3. Include current guidance on existing assessment practices:
   1. Include guidance on pilot batch scale for liquids.
   2. Removal of Professed standards as a separate category from Manufacturing standards.
   3. Include additional flexibility in labelling of storage conditions to align with plain language labelling requirements.
   4. Include terminology and guidance due to the publication of the Master File Guidance.
   5. Harmonize with the notice regarding Interpretation of “Identical Medicinal Ingredient” policy.
   6. Include new guidance on process controls for weight variation
4. Harmonize with the guidance document: Biopharmaceutics Classification System Based Biowaiver (2014).

This guidance document, once finalized and implemented will supersede five existing guidance documents:

1. Quality (Chemistry and Manufacturing) Guidance Document: NDSs and ANDSs (draft, 2001 and 2013);
2. Stability Testing of Existing Drug Substances and Products (2003);
3. Impurities in Existing Drug Substances and Products (draft, 2005).
4. Acceptable Methods (1994)
5. Pharmaceutical Sciences - Questions and Answers (1997)

Consultation Document

ADDENDUM - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers

An addendum has been added to the Quality (Chemistry and Manufacturing) Guidance to capture previously published Questions and Answers regarding the interpretation of guidance. Questions and answers are published from time to time to provide additional clarity and interpretation of guidance. These Questions and Answers as published will be open for comment at the time they are published in the Question and Answer format. During updates to guidance, the interpretation is either incorporated into updated guidance or will be published in this addendum in the Question and Answer format.

Consultation Document

Glossary of Quality Terms

A glossary of key quality terms has been developed to define the terms used in the Draft Guidance Document not currently defined in other relevant Health Canada guidances, or published by other authorities.

Consultation Document

Certified Product Information Document

The Certified Product Information Document (CPID) Template has been updated to ensure consistency with the revised guidance document and a companion guidance document has been provided to simplify completion of this document.

CPID-CE Guidance Document

CPID-CE Template

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

Date of publication of final guidance: To Be Determined

Date of implementation for General Quality Guidance: 3 months after publication of final guidance.

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 2 years after publication of final guidance

Staged implementation:

As of the date of publication of the final guidance, the regulatory project manager will send out a notification advising sponsors of this guidance if a submission does not contain 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 whether stability data on at least 3 primary batches have been submitted.

Two years after the publication of the final guidance, 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: Full implementation 2 years after publication of final guidance

Staged implementation:

As of the date of publication of the final guidance, the regulatory project manager will send out a notification advising sponsors of this guidance if the drug product has been identified as a high-risk of having quality issues or if the pilot scale for a liquid does not meet the criteria outlined in the guidance. The Sponsor Attestation Checklist for ANDSs will be revised at this time to list types of products considered high risk and to confirm whether a commercial scale batch or a pilot scale batch meeting the criteria has been submitted.

Two years after the publication of the final guidance, the regulatory project manager will issue a Screening Deficiency Notice if a submission 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.

Reporting to Canadians

The results of the 2014 consultation are available by email on request.

Health Canada will make the results of this consultation available by email on request.

For more information

To review the individual consultation elements, click on the above links.

For general questions and concerns, please contact:
Email: 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

Interested parties are encouraged to provide comments and suggestions via email, fax or by mail to the above address by December 4, 2016. Subject: Consultation - Quality Guidance