Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)

February 10, 2017
Our file number: 17-101644-531

The Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada is revising the process related to the requirements for evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing adequate assurance of an establishment’s commitment to quality.

Pursuant to Sections C.08.002(2)(e ), C.08.002.01(2)(b), C.08.002.1(2)(a) and C.08.003(2)(e) of the Food and Drug Regulations a new drug submission (NDS), an extraordinary use new drug submission (EUNDS), an abbreviated new drug submission (ANDS), an abbreviated extraordinary use new drug submission (AEUNDS), or a supplement to any of these submissions, shall contain “details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug ”. The “controls ” include those which ensure GMP, and which are required in order to be in compliance with Division 1A (Establishment Licences) and Division 2 to 4 (Good Manufacturing Practices ) of the Regulations.

In order to ensure that submission review resources are dedicated to the assessment of drug submissions for products that can be sold in Canada, and as evidence of an establishment’s commitment to quality, TPD has historically required that buildings  performing licensable activities to be GMP compliant. As of the date of this Notice, and as detailed below, TPD will also accept submissions where a complete application to amend the DEL pursuant to C.01A.006 of the FDR for new buildings and activities not currently listed on the drug submission sponsor’s DEL has been filed with the Minister at least 90 days prior to the time of filing a drug submission.

This requirement will be applicable to all NDS, EUNDS, ANDS, AEUNDS, Supplements, and DIN applications, thereto, submitted to the TPD for review. Eligible submissions are those where (1) all required buildings and activities are listed on the current DEL, (2) a site has a GMP compliance rating in Canada for the required activities and dosage form(s), and/or (3) a complete DEL application has been filed with the Minister for any new buildings and activities. Where a DEL application was needed, the sponsor may file the drug submission 90 days after the Acknowledgment of Application Acceptance for the DEL application is issued by the Minister. Drug submissions which do not meet the requirements listed above will be issued a screening rejection letter.

In addition, where any site listed in a drug submission is considered by Health Canada to be non-compliant for GMP, a screening rejection letter will be issued.

The table below provides a summary of activities that require documentation of a valid DEL and/or DEL application.

Implementation Period

This revised process will come into effect for drug submissions filed after the date of this notice.

Contact Information:

Health Products and Food Branch
Therapeutic Products Directorate
Bureau of Pharmaceutical Sciences
Health Canada

Regulatory Operations and Regions Branch
Health Product Compliance Directorate
Health Product Inspection and Licensing Bureau
Health Canada

Summary of Good Manufacturing Practices ( GMP) Requirements for Drug Submission Purposes
Activity Evidence of Good Manufacturing Practices (GMP)
Included in the drug submission (yes/no)?
Drug Substance
Research and Development Testing no
Manufacture (fabrication) no
Milling or Micronization no
SterilizationFootnote * (including the sterilization of packaging components) yes
Lyophilization for non-sterile drug substances no
Lyophilization for sterile drug substancesFootnote * yes
Testing (drug substance release) for the drug product manufacturer yes
Drug Product
Research and Development Testing no
Manufacture (fabrication) - drug product intermediate yes
Manufacture (fabrication) - final drug product yes
Sterilization (including the sterilization of packaging components) yes
Lyophilization yes
Packaging yes
Labelling yes
Testing (drug substance release, drug product release, and drug product ongoing stability) yes
Storage and Distribution (Canadian sites only) on a case by case basis
Footnote *

Sterilization of a drug substance is considered to be a component of the drug product manufacturing where the final sterile drug product is not subject to filtration or terminal sterilization.

Return to footnote * referrer

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