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Service Standards for Drug Submission Evaluations (Pharmaceuticals & Biologic Products) under the Food and Drug Regulations

Disclaimer: Information on this webpage is provided for illustrative purposes only. The Food and Drug Regulations should be relied upon for specific requirements, including if there are discrepancies between this page and the Next link will take you to another Web site Food and Drug Regulations.

The Health Products and Food Branch (HPFB) commits to service delivery standards to reach first decision outlined as time in average calendar days in the below-noted table (New User Fees - Submissions received after April 1, 2011). All Performance Standards are given in the Management of Drug Submissions Guidance document and not in the User Fee Act/Financial Administration Act Regulations (Fees in respect of Drugs and Medical Devices Regulations) or in the Food and Drug Regulations except for Clinical Trial 30 days in F&D Regs (C.05.008). The 7-day target on 7-day clinical trials is an internal performance standard.

Pharmaceuticals (Linked to the User Fee Act) Time in average Calendar Days

Table 1 footnotes

Table 1 footnote 1

New Drug Submission

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Table 1 footnote 2

Supplemental New Drug Submission

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Table 1 footnote 3

Drug Identification Number Applications

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Table 1 footnote 4

Abbreviated New Drug Submission

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Table 1 footnote 5

Supplemental Abbreviated New Drug Submission

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Table 1 footnote 6

Drug Identification Number - Disinfectant Product

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Table 1 footnote 7

Drug Identification Number - Category IV

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New Active Substance: NDSTable 1 footnote 1 300
Clinical/Chemistry & Manufacturing: NDS 300
Clinical/Chemistry & Manufacturing: SNDSTable 1 footnote 2 300
Clinical Only: SNDS 300
Clinical Only: DIN ATable 1 footnote 3 210
Comparative Studies/Chemistry & Manufacturing: ANDSTable 1 footnote 4 180
Comparative Studies/Chemistry & Manufacturing: NDS 180
Comparative Studies/Chemistry & Manufacturing: SANDSTable 1 footnote 5 180
Comparative Studies/Chemistry & Manufacturing: SNDS 180
Comparative Studies/Chemistry & Manufacturing: DIN A 210
Chemistry & Manufacturing: ANDS 180
Chemistry & Manufacturing: SANDS 180
Chemistry & Manufacturing: SNDS 180
Chemistry & Manufacturing: DIN A 210
Published Data: SNDS 300
Published Data: DIN A 210
Switch from Prescription to Over-the-Counter (No New Indication): SNDS 180
Disinfectant: NDS-D
Disinfectant: SNDS-D
300
300
Disinfectant: NDS-D Clinical/Chemistry & Manufacturing 300
Disinfectant: NDS-D Non-Clinical/Clinical Only 300
Disinfectant: NDS-D Published Data 300
Disinfectant: SNDS-D Clinical/Chemistry & Manufacturing 300
Disinfectant: SNDS-D Clinical Only 300
Disinfectant: SNDS-D Published Data 300
Disinfectant: NDS-D Comparative Studies/Chemistry & Manufacturing 300/180
Disinfectant : NDS-D Chemistry & Manufacturing 300/180
Disinfectant : SNDS-D Comparative Studies /Chemistry & Manufacturing 300/180
Disinfectant: SNDS-D Chemistry & Manufacturing 300/180
Disinfectant: DIN D (Non-Clinical/Clinical Only)Table 1 footnote 6 210
Pharmaceuticals Time in average Calendar Days
Disinfectant: DIN D (Labelling Only) 180
Labelling Only: NDS 60
Labelling Only: SNDS 60
Labelling Only: ANDS 60
Labelling Only: SANDS 60
Labelling Only: DIN A 180
Labelling Standard: DIN A 45
Labelling Standard: DIN D 45
Labelling Standard: DIN FTable 1 footnote 7 45
Administrative: ANDS 45
Administrative: NDS 45
Administrative: NDS-D 45
Administrative: SNDS 45
Administrative: SNDS-D 45
Administrative: SANDS 45
Administrative: DIN A 45
Administrative: DIN D 45
Pharmaceuticals (Not linked to the User Fee Act) Time in Calendar Days Performance standard
Notifiable Change Submissions (Quality 90) 90 90% within time shown
Notifiable Change Submissions (Safety 90) 90
Notifiable Change Submissions (Safety 120) 120
Notifiable Change Submissions - Administrative 45
Post-Authorized Division 1 Change (PDC) 45 90%
Clinical Trial Applications and Amendments - Phase I (bioequivalence; healthy human) 7 100%
Clincial Trial Applications and Amendments - Phase I (all other), Phase II, Phase III 30 100%
Biologics (Linked to the User Fee Act) Time in Calendar Days

Table 2 footnotes

Table 2 footnote 1

New Drug Submission

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New Active Substance: NDSTable 2 footnote 1 300
Clinical/Chemistry & Manufacturing: NDS 300
Clinical/Chemistry & Manufacturing: SNDS 300
Clinical Only: SNDS 210
Chemistry & Manufacturing: ANDS 180
Chemistry & Manufacturing: SANDS 180
Chemistry & Manufacturing: SNDS 180
Chemistry & Manufacturing: DINB 210
Comparative Studies/Chemistry & Manufacturing: ANDS 180
Comparative Studies/Chemistry & Manufacturing: SNDS 180
Labelling Only: SNDS 60
Published Data: SNDS 300
Administrative: NDS 45
Administrative: DINB 45
Biologics (Not linked to the User Fee Act) Time in Calendar Days Performance standard
Notifiable Change Submissions (Quality 90) 90 90% within time shown
Notifiable Change Submissions (Safety 90) 90
Notifiable Change Submissions (Safety 120) 120
Notifiable Change - Administrative 45
Clinical Trial Applications and Amendments 30 100%

Performance Targets

The target for achieving these standards is as follows:

For NDS, SNDS, ANDS, SANDS, and DIN submissions: The target for the average time to reach first decision on a submission within an individual fee line is given in the above table.

For Notifiable Change submissions and Clinical Trial Applications and Amendments: The target for achieving these standards is set at 90% of submissions within the applicable review timelines for Notifiable Change Submissions and at 100% for Clinical Trial Applications and Amendments (also indicated in the above table).

Performance Results

Annual service performance is measured over the course of the fiscal year (April 1 - March 31). Performance results for a given fiscal year are published in the Departmental Performance Report, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

In 2014-2015, HPFB's actual results for these submissions were:

Pharmaceuticals Time in Calendar Days

Table 3 footnotes

Table 3 footnote 1

New Drug Submission

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Table 3 footnote 2

Supplemental New Drug Submission

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Table 3 footnote 3

Drug Identification Number Applications

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Table 3 footnote 4

Abbreviated New Drug Submission

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Table 3 footnote 5

Supplemental Abbreviated New Drug Submission

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Table 3 footnote 6

Drug Identification Number - Disinfectant Product

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Table 3 footnote 7

Drug Identification Number - Category IV

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New Active Substance: NDSTable 3 footnote 1 257
Clinical/Chemistry & Manufacturing: NDS 278
Clinical/Chemistry & Manufacturing: SNDSTable 3 footnote 2 280
Clinical Only: NDS n/a
Clinical Only: SNDS 257
Clinical Only: DIN ATable 3 footnote 3 208
Comparative Studies/Chemistry & Manufacturing: ANDSTable 3 footnote 4 171
Comparative Studies/Chemistry & Manufacturing: NDS 167
Comparative Studies/Chemistry & Manufacturing: SANDSTable 3 footnote 5 168
Comparative Studies/Chemistry & Manufacturing: SNDS 155
Comparative Studies/Chemistry & Manufacturing: DIN A 178
Chemistry & Manufacturing: ANDS 173
Chemistry & Manufacturing: NDS 161
Chemistry & Manufacturing: SANDS 151
Chemistry & Manufacturing: SNDS 161
Chemistry & Manufacturing: DIN A 168
Published Data: SNDS 230
Published Data: DIN A n/a
Switch from Prescription to Over-the-Counter: SNDS 161
Disinfectant: NDS-D 299
Disinfectant: SNDS-D n/a
Disinfectant: DIN D (NonClin/Clin Only)Table 3 footnote 6 196
Disinfectant: DIN D (Labelling Only) n/a
Labelling Only: NDS 52
Labelling Only: SNDS 51
Labelling Only: ANDS 47
Labelling Only: SANDS 33
Labelling Only: DIN A 159
Labelling Standard: DIN A 32
Labelling Standard: DIN D 39
Labelling Standard: DIN FTable 3 footnote 7 24
Administrative: ANDS 34
Administrative: NDS 33
Administrative: SNDS 25
Administrative: SANDS 32
Administrative: DIN A 33
Administrative: DIN D 33
(Indicated in TPD & Biologics Annual Reports) Percentage Within Target
Notifiable Change Submissions (Safety 90) 85%
Notifiable Change Submissions (Safety 120) 91%
Notifiable Change Submissions - Administrative (45 days) - combined pharmaceutical and biologic 100%
7 day Clinical Trial Applications (CTA) and Amendments (CTA-A) - Phase I (bioequivalence; healthy human) 93% for CTA
88% for CTA-A
30 day Clinical Trial Applications and Amendments - Phase I (all other), Phase II, Phase III 100% for CTA
100% for CTA-A
Biologics Time in Calendar Days
New Active Substance: NDS 270
Clinical/Chemistry & Manufacturing: NDS 268
Clinical/Chemistry & Manufacturing: SNDS 289
Clinical/Chemistry & Manufacturing: DIN B 210
Clinical Only: SNDS 268
Chemistry & Manufacturing: ANDS 180
Chemistry & Manufacturing: SANDS 180
Chemistry & Manufacturing: SNDS 160
Chemistry & Manufacturing: DINB 210
Comparative Studies/Chemistry & Manufacturing: ANDS 178
Comparative Studies/Chemistry & Manufacturing: SNDS 188
Labelling Only: SNDS 51
Published Data: SNDS 242
Administrative: NDS 40
Administrative: DINB 40
Biologics Percentage Within Target
Notifiable Change Submissions (Quality 90) 99%
Notifiable Change Submissions (Safety 90) 99%
Notifiable Change Submissions (Safety 120) 100%
Notifiable Change Submissions - Administrative (45 days) 100%
Clinical Trial Applications and Amendments 99% for CTA
100% for CTA-A

Applying for Drug Submission Evaluations

Context

Division 1 and Division 8, Part C of the Next link will take you to another Web site Food and Drug Regulations provides governance on the sale of drugs in Canada and prohibits the sale of drugs unless the manufacturer has filed a submission that is satisfactory to the Minister.

Application Process

The Guidance for the Management of Drug Submissions (MDSG) is meant to assist drug manufacturers (sponsors) with applying for Drug Submission Evaluations and is a fluid document that outlines the way in which the Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) manage information and material submitted by sponsors in accordance with the Next link will take you to another Web site Food and Drugs Act and Next link will take you to another Web site Regulations.

This diagram illustrates Health Canada's roles in drug licensing processes. The standards contained herein pertain specifically to the Submission Review portion of this diagram.

Health Canada's Lifecycle Approach to Health Product Vigilance

Health Canada's Lifecycle Approach to Health Product Vigilance

Cost Recovery

Fees for the Review of Drug Submissions and Applications guidance document provides guidance on the interpretation of the Next link will take you to another Web site Fees in Respect of Drugs and Medical Devices Regulations with a focus on how the fees for the review of a new drug submission (NDS), a supplement to a new drug submission (SNDS), an abbreviated new drug submission (ANDS), a supplement to an abbreviated new drug submission (SANDS) and a drug identification number (DIN) application contained in Part 2, Division 1  in respect of the submission class  and fee set out in Schedule 1 of these regulations will be administered.

Cost recovery refers to the act of charging a fee for a government service to those who receive the service or benefit from it.  In March 2004, the Next link will take you to another Web site User Fees Act became law, which links service standards with fees charged and collected by a program or department.

Notifiable change submissions and clinical trial applications are not cost recovered.

Departmental Contacts

Please contact the Licensing Program to make any general inquiries or comments:

  • Office of Submissions and Information Policy
    Therapeutic Products Directorate
    Health Canada
    Finance Building
    101 Tunney's Pasture Driveway
    Address Locator 0201A1
    Ottawa, Ontario  K1A 0K9
    Telephone: (613) 941-7281
    Teletypewriter: 1-800-465-7735 (Service Canada)
    Fax: (613) 946-5610, (613) 941-0825
    E-mail: OSIP-BPPI@hc-sc.gc.ca


  • On Cost Recovery:
    E-mail: OSIP-CostRecov-BPPI-RecouvCout@hc-sc.gc.ca
    Telephone: 613-941-7283
    Fax: 613-941-0285

Additional Information

Service Feedback

Dispute prevention and early resolution are key to minimizing the impacts of disputes both internally and externally, and to improving relations between Directorates and their stakeholders. TPD and BGTD will make every effort to identify, manage, and resolve disputes at the level at which they take place.

Dispute prevention and early resolution will primarily take place through improved communication among Directorate staff, and between the Directorates and submission sponsors. Mechanisms to improve communication will include the following:

  • Improved communication throughout the submission process via the Regulatory Project Managers (RPMs, TPD) and Regulatory Project Officers (RPOs, BGTD), so that the sponsor and the Directorate are fully aware of issues and ongoing activities related to the drug and/or the submission.
  • More frequent and effective use of pre-submission meetings; best practices will be followed to ensure meetings are well-organized, efficient, productive, and properly documented. This will allow for greater clarity and discussion of issues earlier in the drug submission process, therefore preventing disputes from arising at later stages.
  • More frequent use of post-Notice meetings and teleconferences to provide clarification on the decision and discuss how the sponsor can best respond. These will help to prevent disputes from arising, and allow for informed discussion of those that cannot be prevented.

Disputes that arise within the drug submission process will be initiated at the level at which they take place, and will be addressed as they occur. The RPMs in TPD and the RPOs in BGTD will serve as the primary points of contact between the review bureaux/centres and the submission sponsor, and will be responsible for managing disputes that arise within the submission process. Sponsors who disagree with the way in which their submission is being processed should contact the RPM or RPO assigned to their submission to discuss the issue under dispute. The RPM or RPO will then raise the issue with the review bureau/centre, and will make every attempt to resolve the dispute in a timely manner.

The RPM or RPO is also responsible for ensuring that the dispute and its resolution are appropriately communicated to the review team and to the sponsor. Details of the dispute and its resolution will be documented and filed, including who was involved in the review of the dispute, discussions that took place, decisions that were made, and associated dates. All correspondence will be placed on the file, as will the record of decisions from any meetings or discussions that take place either within the Directorate or with the sponsor (including telephone conversations).

For further information on dispute resolution, see Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions.

Should performance standards for a particular drug evaluation fee line not be met over the course of a fiscal year, user fees associated with that fee line will be reduced for the following fiscal year. Section 5.1 of the User Fees Act (2004) mandates that, in the event that performance in a given fiscal year does not meet the associated standard by at least ten percent, the user fee for the following fiscal year will be reduced by a percentage equivalent to the unachieved performance, to a maximum of fifty percent. The reduced user fee will go into effect upon the tabling in Parliament of the Departmental Performance Report (DPR) for the fiscal year in which performance was not met, and will continue until the tabling of the DPR for the following fiscal year.

For More Information

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Next link will take you to another Web site Canada Gazette and Next link will take you to another Web site Consulting with Canadians websites.