Guidance on management of drug submissions and applications: Pre-application and filing
On this page
- Classification of therapeutic products
- Submission and application pathways an policies
- Pre-submission or pre-application meeting
- Filing with Health Canada
Classification of therapeutic products
To file information for a proposed therapeutic product, you should know how your product is classified (for example, as a drug, biologic, medical device or combination product).
Classification refers to the process of interpreting which regulatory framework under the Food and Drugs Act (act) applies to a product. For example, it may be needed to determine whether a therapeutic product is regulated as a device or a drug, and if it’s a drug, to which sub-type it belongs (biologic, pharmaceutical, natural health product).
In most cases, the distinction between drugs and devices is clear and these products can be easily classified according to their definitions found in section 2 of the act. Most classifications are made by the appropriate program area upon submission of required information, or application for market authorization. But as new technologies and products emerge, it can be more difficult to identify the appropriate framework under which these products should be regulated.
When needed, the Therapeutic Products Classification Committee (TPCC) may be consulted. The TPCC primarily provides recommendations on the classification of a product as either a drug (pharmaceutical, biological, or natural health product), medical device, or combination product. When appropriate, other regulatory areas of Health Canada may be asked to participate in the committee’s discussion.
Classifications are based on available evidence at a point-in-time, and may be additionally influenced based on the full review of a submission of required information, or application for market authorization. Relevant acts and regulations are the central frameworks for product classification at Health Canada. Classification and subject matter experts from Health Canada’s regulatory areas help to determine how a product is classified, taking into consideration:
- the definitions found in the act (section 2 on interpretation and application)
- inclusion and exclusion criteria of the implicated regulatory frameworks and
- criteria outlined in various classification guidance documents depending on the interface or product type
For more information, consult:
- Classification of products under the Food and Drugs Act
- Classification of health products at the device-drug interface
- Guidance document: Factors influencing the classification of products at the device-drug interface
For questions about the classification of products at the device-drug interface, email us at drug.device.classification-drogue.instrument@hc-sc.gc.ca.
Combination products
Health Canada regulates a number of product types, including where multiple products may be co-packaged or have a combined use. A subset of combined-use products may be classified as a drug-device combination product (DDCP). DDCPs are health products that combine drugs and medical devices as a single entity.
You may request a classification for a drug-device combination product that has not been previously classified by emailing the Health Product Classification Unit: drug.device.classification-drogue.instrument@hc-sc.gc.ca.
Or, you may file a submission or application to a review centre, bureau or office (review area) based on your own classification and identification of the primary component. You will be notified if you filed the submission or application incorrectly. The review area that received your submission or application will consult with the appropriate expert area for the ancillary component as required, to ensure it is safe, effective and of high quality before licensing the primary component.
Submissions and applications for a drug-device combination product are:
- handled in accordance with the policy for drug and medical device combination products
- subject to the Medical Devices Regulations, the Natural Health Products Regulations or the Food and Drug Regulations based on the principal mechanism of action by which the claimed effect or purpose is achieved
Both principal and ancillary components must meet acceptable standards of safety, efficacy and quality.
Send your submission or application to the relevant review area as follows:
- for a drug-device combination product where a drug is the primary component: to the Office of Submissions and Intellectual Property (OSIP)
- for a drug-device combination product that’s classified as a drug, subject to the Natural Health Products Regulations: to the Natural and Non-prescription Health Products Directorate (NNHPD)
- for a combination product where a medical device is the primary component: to the Medical Devices Directorate
Other regulations that influence the classification of a drug
Once a product has been classified as a drug and not a device at the level of the Food and Drugs Act, further classification is required to determine if the product is a:
- pharmaceutical or biologic drug subject to the Food and Drug Regulations or
- natural health product, a subset of drugs under the act and subject to the Natural Health Products Regulations (NHPR)
This further classification is guided by the following:
- definition for a natural health product in section 1 of the NHPR
- exclusion of prescription drugs in section 2(2) and
- inclusive and exclusive lists of substances set out in Schedules 1 and 2 to the NHPR
Personal care products may share characteristics of both a “cosmetic” and a “drug”, as currently defined under the Food and Drugs Act. They could fall under the Cosmetic Regulations, the Food and Drug Regulations or the Natural Health Products Regulations.
Learn more about the criteria used to determine the appropriate regulatory regime that applies to a given product at the cosmetic-drug interface:
If you have questions about which regulatory framework may apply to a particular health product or about the classification of products at the drug-medical device interface, e-mail us at drug.device.classification-drogue.instrument@hc-sc.gc.ca.
Submission and application pathways and policies
These pathways and policies do not apply to clinical trial applications (CTAs) or amendments to clinical trial applications (CTA-As).
Some submission and application pathways and policies are strictly for specific submission and application types or classes. Sponsors should consult existing guidance and policy documents to become familiar with the requirements of each submission and application type or class.
Priority review
Sponsors who want a priority review of a new drug submission (NDS) or supplement to a new drug submission (SNDS) should request this before filing the submission.
Requests for priority review status should be sent to OSIP to the attention of the director of the appropriate centre, bureau or office.
You may file your NDS or SNDS once we have reviewed your priority review request. If your drug submission was granted priority review, you must clearly state this in your cover letter and file the submission within 60 calendar days.
For more information on priority review requests and submissions, including performance standards, consult:
Notice of compliance with conditions (NOC/c)
Sponsors who want to be given advance consideration to file a submission under the NOC/c policy should request a pre-submission meeting with the appropriate review work area. (Refer to the following section on this page for more information.)
You should file your submission as an NDS, SNDS, abbreviated new drug submission (ANDS) or supplement to an abbreviated new drug submission (SANDS). If your drug submission was deemed eligible for advance consideration, you must clearly state this in your cover letter and file the submission within 60 calendar days.
If we issued an NOC/c, you should file the results from confirmatory trials outlined in the letter of undertaking as an SNDS-c or SANDS-c.
For more information on eligibility, procedural requirements and the performance standards, consult:
Extraordinary use new drug
Submissions eligible under the criteria set out in C.08.002.01 (1) of the Food and Drug Regulations may be filed as:
- an extraordinary use new drug submission (EUNDS)
- a supplement to an extraordinary use new drug submission (EUSNDS)
- an abbreviated extraordinary use new drug submission (EUANDS) or
- a supplement to an abbreviated extraordinary use new drug submission (EUSANDS)
These submissions have the same performance standards as the corresponding NDS, SNDS, ANDS or SANDS.
For submission requirements, consult:
Public health emergency drug
Submissions eligible for modified requirements under the criteria set out in C.08.001.1 of the Food and Drug Regulations may be filed as an NDS or SNDS.
For submission requirements, consult:
Biosimilar biologic drug
Biosimilar biologic drugs, like all new drugs, are subject to Part C, Division 8 of the Food and Drug Regulations for authorization and oversight. Submissions for biosimilar biologic drug products should be filed as an NDS or SNDS and have the same performance standards as the corresponding NDS or SNDS.
For submission requirements, consult:
Administrative processing
Eligible drug submissions and applications will be processed under the administrative pathway. We screen the information submitted in your submission or application to ensure it is complete and of suitable quality for the intended purpose.
For more information, consult:
Pre-submission or pre-application meeting
You may request a pre-submission or pre-application meeting with the appropriate directorate within Health Canada. These meetings may be conducted in person or by videoconference.
A pre-submission or pre-application meeting is held to answer any questions or concerns you may have before you file a:
- drug submission or application
- for example, NDS, SNDS, ANDS, SANDS, DINA
- clinical trial application
- request for a combination product classification
- for example, medical device-drug, drug-drug
- request for a priority review
- request for advanced consideration of a submission under the NOC/c policy
- submission for an EUNDS
- submission for a public health emergency drug
- submission relying on third-party data
- response to a notice of deficiency (NOD) or notice of non-compliance (NON)
A pre-submission or pre-application meeting also gives an opportunity for Health Canada to:
- discuss the data in support of the proposed submission or application
- become familiar with the submission or application before it’s filed
- identify potential problems or issues and manage disputes early in the submission or application process
- learn about the studies being used to establish the drug’s safety and efficacy
- offer feedback on the regulatory requirements
- discuss the potential eligibility of the submission for priority review or NOC/c consideration
- improve the quality of information being submitted
- re-align resources within the directorate to accommodate the arrival of the submission or application
Note: While the data may be discussed at the meeting, its acceptability is only considered during the scientific review of the proposed submission or application.
For clinical trial consultation meetings, make sure that the requested feedback relates to clinical trial information and not market authorization requirements. For example, a meeting request to discuss pivotal clinical trials for market authorization may require a pre-NDS meeting and not a pre-clinical trial application (CTA) meeting.
Consult section 2.2. in:
For pre-submission meetings for priority review requests or requests for advance consideration of a submission under the NOC/c policy, consult:
- Guidance to industry: Priority review of drug submissions
- Guidance document: Notice of compliance with conditions
For pre-submission meetings relying on third-party data, consult:
Meeting requests
For pre-CTA meeting requests, submit your request as follows:
- use the Common Electronic Submissions Gateway (eCTD dossiers)
- email the appropriate directorate (non-eCTD dossiers)
For pre-CTA meeting requirements, consult section 2.2.1 in:
For other pre-submission and application meeting requests, contact the appropriate review work area.
You should send an administrative cover letter and your meeting request to the director of the appropriate review area as early as possible. We recommend that this be done 3 or more months in advance of the proposed meeting date. Send these in an acceptable submission format (refer to the following section on filing with Health Canada).
Learn more about Filing submissions electronically.
Submit your meeting request in a separate document (not in the cover letter) and include the following information:
- purpose of meeting
- for example, pre-NDS, pre-phase 3, pre-response to an NOD or NON
- details about the product to be discussed
- for example, active ingredient, dosage form and therapeutic classification, including whether the drug is first in class
- enough information about the product to help Health Canada assess whether the meeting is needed
- questions to be addressed during the meeting
- submission or application information (such as control number, product name) and a copy of the NOD or NON if the meeting concerns a response to an NOD or NON
- 3 meeting date suggestions, with afternoons or mornings indicated
- suggestions for review expertise that may be needed for meeting
- for example, clinical, chemistry or biopharmaceutics reviewers, biostatisticians
- if the drug submission will rely on third-party data
If necessary, you will be contacted by a regulatory project manager (RPM) or senior regulatory affairs officer (SRAO) in 1 of the following directorates to discuss the meeting request:
- Pharmaceutical Drugs Directorate (PDD)
- Natural and Non-prescription Health Products Directorate (NNHPD)
- Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
If we determine that a meeting is needed, we will confirm possible meeting dates, the overall content of the pre-submission or application package and number of participants. We may decline the meeting request if the information listed in this section has not been provided.
If we believe that a meeting is not needed, we will respond with our reasons in a reasonable time period.
Meeting packages
You will be asked to submit a pre-submission or pre-application meeting package in an acceptable file format at least 1 month before the meeting.
Refer to the following section for information on formats.
For information on the pre-clinical trial applications consultation information package, consult section 2.2.2 in:
If you are making a presentation, you should submit your slide deck 1 week before the meeting.
Pre-submission or pre-application meeting packages should be as concise as possible and contain the following information, where applicable:
- cover letter
- proposed meeting agenda
- brief slide presentation
- brief summary of the drug product
- identification of the indications for which approval is sought
- proposed strengths and dosages
- summary of the clinical development plan for the drug, including clinical trials that have been completed in Canada (if any) and trials that are ongoing (if any)
- summary of the development of the product, including any changes in production process, dosage form and testing methods and a description of the manufacturing process
- summary of the safety and efficacy data relating to the drug (for example, draft of the product monograph)
- overview of the market history of the product, including its foreign regulatory status
- list of specific issues or questions (grouped by discipline) that are to be discussed
- projected submission or application filing date
Note: We may request meeting packages in hard copy.
Post-meeting requirements
After the pre-submission or pre-application meeting, meeting minutes should be drafted and sent to us no later than 2 weeks after the meeting. Submit the final meeting minutes in an acceptable file format.
Refer to the following section for information on formats.
For information on the pre-clinical trial applications consultation meeting records, consult section 2.2.3 in:
When filing your submission or application, you should reference the following information in the cover letter:
- control number of the pre-submission or pre-application meeting
- confirmation that the submission or application reflects what was committed to at the meeting
- minutes of the meeting
- other pre-submission or pre-application correspondence with Health Canada
It is in your best interest to file a submission or application within a reasonable time period following the pre-submission or pre-application meeting.
Filing with Health Canada
Your submission or application must contain enough information to satisfy the regulatory requirements set out in Part C of the Food and Drug Regulations. All submitted information and subsequent information (solicited and unsolicited) should be included with the cover letter. Be sure to indicate the reason for filing the information and the date filed in the letter.
Acceptable formats for filing
We accept submissions and applications in the electronic common technical document (eCTD) electronic-only format and the non-eCTD electronic-only format via Common Electronic Submission Gateway (CESG) using the Regulatory Enrolment Process (REP).
For acceptable formats, refer to the appropriate section in Filing submissions electronically:
- Preparation of regulatory activities in eCTD format
- Preparation of regulatory activities in non-eCTD format
Filing formats and where to file for CTAs and CTA-As
The clinical trial application (CTA) or amendment to a clinical trial application (CTA-A) may be submitted in eCTD or non-eCTD format.
Refer to the appropriate section for the requirements in Filing submissions electronically.
Submit your CTA or CTA-A by email or by courier (on electronic media) to the appropriate directorate:
- Pharmaceutical Drugs Directorate: oct.smd-dgp.bec@hc-sc.gc.ca
- Biologic and Radiopharmaceutical Drugs Directorate: brdd.cta-dec.dmbr@hc-sc.gc.ca
If you file by email, note the following email restrictions:
- The maximum email size accepted by the corporate mail server is 20 megabytes (MB).
- As individual files larger than 10 MB have been rejected by our mail server, we recommend that you split files larger than 10 MB into 2 or more files.
- The regulatory transaction must be provided as a zipped file, in accordance with the requirements for non-eCTD electronic-only formats.
- The submissions should not be password-protected.
- The subject line of the email should state: “CTA(-A) [product name], [protocol number]”.
- Emails received after 3 pm EST will be considered received the following day.
For more information, consult sections 2.3.2 and 2.4.4 in: