Guidance on management of drug submissions and applications: Definitions, glossary, notes

On this page

• Definitions
• Glossary
• Notes on terminology and types of administrative holds

Definitions

Biologic drug: A drug listed in Schedule D to the Food and Drugs Act.

Biosimilar biologic drug: The term biosimilar biologic drug (or biosimilar) is used by Health Canada to describe subsequent entry versions of a Canadian-approved innovator biologic with demonstrated similarity to a reference biologic drug. Biosimilars were previously referred to as subsequent entry biologics (SEBs) in Canada.

Control number (may also appear as submission number): The ID number assigned to submissions and applications in the Drug Submission Tracking System.

Dossier: A collection of all regulatory activities throughout the life cycle of a product.

Dossier identifier (dossier ID): A number created by Health Canada to uniquely identify the dossier for a specific drug product.

Drug: According to the Food and Drugs Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:

• diagnosing, treating, mitigating or preventing a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals
• restoring, correcting or modifying organic functions in human beings or animals or
• disinfecting premises where food is manufactured, prepared or kept

For the purposes of this guidance, drug refers to:

• prescription and non-prescription pharmaceuticals
• biologically-derived products such as vaccines, blood-derived products and products produced through biotechnology
• cells and some tissues
• disinfectants
• radiopharmaceuticals

Drug/medical device combination product: A therapeutic product that combines a drug component and a device component (which by themselves would be classified as a drug or a device), such that the distinctive nature of the drug component and device component is combined in a singular product.

Note: While drug/medical device combination products include some co-packaged products, this definition does not apply to co-packaged products classified as kits, which may also include a combination of drugs and medical devices.

Ethical drug: A drug that, in accordance with federal legislation, does not require a prescription, but is generally prescribed by a medical practitioner. Ethical products are unscheduled non-prescription professional-use products (such as magnetic resonance imaging contrast agents, hemodialysis solutions) and a few emergency use products (such as nitroglycerine).

Filing date: The date that the submission or application is deemed administratively complete by Health Canada. For example, the submission or application contains all necessary certification forms, the REP Product Information and REP Regulatory Transaction templates, including a completed fees section, and meets the requirements of section 5 of the Patented Medicines (Notice of Compliance) Regulations, where applicable.

This date may differ from the date of original receipt should the submission or application be considered administratively incomplete at the time of receipt. The filing date established for a submission or application is not affected by subsequent screening or review activities. In the Drug Submission Tracking System – Industry Access, the filing date was previously referred to as the “CR Date”.

Note: A submission or application received after 5:00 pm Eastern Standard Time, during a weekend or on a statutory holiday, is considered to be received on the next business day.

Generic drug: A generic drug is a copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand name drug and contains the identical medicinal ingredients, in the same amounts and in a similar dosage form. Generic medications may have different non-medicinal ingredients than the brand name drug, but the company must show that these do not affect its safety, efficacy or quality. Generic drugs are approved as abbreviated new drug submissions (ANDSs).

Manufacturer or sponsor: For drug products, the manufacturer or sponsor is the name under which the drug submission is filed. Where a drug identification number (DIN) or notice of compliance (NOC) is to be issued, this is the company in whose name the DIN or NOC will be registered (the DIN or NOC holder) and whose name must be included on the product label and product monograph or package insert. For clinical trial applications (CTAs) and amendments to clinical trial applications (CTA-As), a sponsor is defined by Division 5, Part C of the Food and Drug Regulations as the individual, corporate body, institution or organization that conducts a clinical trial. The sponsor is not necessarily the company that makes the drug product.

For medical devices, the manufacturer is the person (includes a partnership, firm or association) who:

• sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person and
• is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf

Medical device: As stated in the Food and Drugs Act, is an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in either:

1. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals
2. restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals
3. diagnosing pregnancy in human beings or animals
4. caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring
5. preventing conception in human beings or animals

Does not include an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by:

• pharmacological, immunological or metabolic means or
• chemical means in or on the body of a human being or animal

Non-prescription drug: A drug that can be bought without a practitioner’s prescription (not included in the Prescription Drug List).

Prescription drug: A drug that is:

• set out in the Prescription Drug List, as amended from time to time, or
• part of a class of drugs that is set out in the Food and Drugs Act

Regulatory activity: A collection of all regulatory transactions throughout the process of a specific activity, such as, for example, a new drug submission (NDS), abbreviated new drug submission (ANDS) or drug identification number application (DINA).

Therapeutic product: A drug or device or any combination of drugs and devices.

Glossary

ANDS:

abbreviated new drug submission

C&M:

chemistry and manufacturing (quality)

Clin:

clinical

Comp:

comparative studies (bioavailability, clinical, pharmacodynamics or pharmacokinetic)

CTA:

clinical trial application

CTA-A:

clinical trial application – amendment

DDCP:

drug-device combination product

DIN:

drug identification number

DINA:

application for a DIN

DINB:

application for a DIN - biological product

DINF:

application for a DIN - category IV product

DIND:

application for a DIN - disinfectant product

EUNDS:

extraordinary use new drug submission

EUSNDS:

supplement to an extraordinary use new drug submission

EUANDS:

abbreviated extraordinary use new drug submission

EUSANDS:

supplement to an abbreviated extraordinary use new drug submission

NAS:

new active substance

NC:

notifiable change

NDS:

new drug submission

NDS-D:

new drug submission for a disinfectant product

NOC:

notice of compliance

NOC/c-QN:

notice of compliance with conditions - qualifying notice

NOD:

notice of deficiency

NOL:

no objection letter

NON:

notice of non-compliance

NSN:

not satisfactory notice

PDC:

post-authorization Division 1 change (includes prescription, non-prescription, and disinfectant PDCs)

PDC-B:

post-authorization Division 1 change for biologics

PHED:

public health emergency drug

SANDS:

supplement to an abbreviated new drug submission

SANDS-c:

supplement to an abbreviated new drug submission - confirmatory

SNDS:

supplement to a new drug submission

SNDS-c:

supplement to a new drug submission - confirmatory

SNDS-D:

supplement to a new drug submission for disinfectant products

Notes on terminology and types of administrative holds

Terminology for interpretation of performance standards

Class: Submission class based on information included in submission (except for a new active substance, which applies to a medicinal ingredient not previously approved in a drug for sale in Canada), corresponding to the fee class.

NOC/c: Submissions that have been accepted for advance consideration under the notice of compliance with conditions policy.

Priority: Submissions that have been accepted for priority status according to the priority review of drug submissions.

Process: The 10-day processing period where OSIP verifies that the information submitted to Health Canada as a response to an SDN, an NOD or an NON is administratively complete.

Process for an initial submission or application: The 10-day processing period where the Office of Submissions and Intellectual Property (OSIP) verifies that the information submitted to Health Canada in an initial submission or application is administratively complete.

Review 1: Period from date of acceptance to:

• an NOL or NSN issued for a CTA, CTA-A, NC, PDC (for prescription drugs only) or PDC-B or
• an NOD, NOD-W, NON, NOC/c-QN or NOC for all other submissions

Review 2: Period from date of acceptance of response to the date of an NON to an NOC or an NON-W letter.

Review of response to NOC/c-QN: Period from date of acceptance of response to an NOC/c-QN sent under the notice of compliance with conditions policy

Screening 1: Period from date of receipt to the date of acceptance, rejection, SDN or withdrawal for an unacceptable response to NOD screening.

Screening 2: Period from date of receipt of response to an NON to the date of acceptance or withdrawal for unacceptable response to NON screening.

Learn more about the performance standards.

Types of administrative holds

Not applicable to CTAs or CTA-As.

Data protection refused hold: Manufacturers who seek a notice of compliance (NOC) based on a direct or indirect comparison with an innovative drug will not be permitted to file the submission for 6 years from the date the NOC was issued for the innovative drug. They will be given a preliminary decision by letter informing them of the intent to reject their submission and granting a period in which to provide representations. If, following consideration of the representations, the Office of Submissions and Intellectual Property (OSIP) believes that the submission cannot be filed, a final decision will be issued and the submission will be deleted.

Intellectual property hold: When the scientific review of a submission for a Division 8 product is complete and the submission is found to be in compliance, the sponsor will be notified that the submission has been placed on intellectual property hold. This is done until, as applicable, the:

• requirements of the Patented Medicines (Notice of Compliance) Regulations have been met and
• term of market exclusivity for an innovative drug in accordance with the data protection provisions at section C.08.004.1 of the Food and Drug Regulations has expired

While on intellectual property hold, subsequent SNDSs, SANDSs, NCs and post-market vigilance data will be accepted into review. Once the regulations and provisions have been satisfied, the original NOC and subsequent NOCs or NOLs are sent to the sponsor.

Learn more about issues related to intellectual property:

• Guidance document: Patented Medicines (Notice of Compliance) Regulations
• Guidance document: Data protection under C.08.004.1 of the Food and Drug Regulations

Patent-form V hold: For submissions subject to the provisions of the Patented Medicines (Notice of Compliance) Regulations, Health Canada is required to ensure that all relevant patents have been addressed through the filing of a Form V – Declaration Re: Patent List. OSIP will notify the sponsor when patent requirements are not met and the original information will be placed on Form V Hold. Once all the Form V requirements have been met, the received date will be entered and the submission will be sent to the relevant review bureau or centre.

However, if the Form V requirements have not been met within the period outlined in OSIP’s letter, the sponsor will be notified that the submission is cancelled and the submission status will be changed to “Cancel Process”.

Process hold – initial: OSIP will place the original information on process hold - initial when:

• more information such as a certification form is required
• the electronic data is not in CTD structure or
• a validation report with error is issued

Once the reason for the process hold - initial is addressed, the submission continues through the standard submission processing route.

If the company does not provide the requested information within 10 days, a final letter is sent to them. This letter notifies them that the information initially provided is considered administratively incomplete and the submission will be cancelled. The status of the submission or application will be changed to “Cancel Process”. The company may refile.

Process hold: A submission is placed on process hold when the response to an NOD, NON or SDN is administratively incomplete (for example, has missing or incomplete forms) or a validation report with error is issued.

If the company does not provide the requested information within 10 days, a final letter is sent to them. The letter notifies them that the response will not be accepted.

When the missing information is received by OSIP, the received date will be entered and the response forwarded to the working area that’s reviewing the submission or application.

For CTAs and CTA-As, a submission will be placed on process hold when the submission is administratively incomplete (for example, has missing or incomplete forms or is missing documents). When the missing information is received by OCT in PDD or ORA in BRDD, the received date will be entered and the regulatory review (30-day regulatory default period) will begin.

Regulatory hold: When the scientific review of the submission is complete and there are outstanding regulatory requirements (for example, completion of an on-site evaluation related to the review of a biologic), the submission will be placed on regulatory hold. A submission may also be placed on regulatory hold when there are pending related regulatory amendments.

Switch hold: This hold occurs after the review of a submission for a switch from prescription to non-prescription status has been completed. If the submission met the regulatory requirements and demonstrated that practitioner involvement may not be required, the submission is placed on hold. It remains on hold pending the outcome of the proposal to remove the medicinal ingredient or medicinal ingredients for certain conditions of use from Prescription Drug List.

Issuance of decision documents

The following tables list the submission or application type or category (for example, Division 1 or Division 8 drugs) and the individual responsible for signing the decision document.

Table 1. Notice of deficiency (NOD)

Division number	PDD	NNHPD (NDED)	BRDD
Division 8 drugs	Director General	Director General	Director General
Division 1 drugs: DINA (not applicable to a DINA for a labelling standard or a labelling standard to a category IV monograph) DIND DINB)	Director	Division manager	Director General

Table 2. No objection letter (NOL)

Type	PDD	NNHPD (NDED)	BRDD
CTA or CTA-A	Division manager	N/A	Senior Regulatory Affairs Officer
Notifiable changes (NC) (for human biologic or radiopharmaceutical drug quality changes)	N/A	N/A	Senior Regulatory Affairs Officer
Division 1 drugs: DINA,(not applicable to a DINF and a DINA for a labelling standard) DIND DINB) (approval letters signed by the director general are issue for all DIN-Bs)	Director	Division manager or reviewer	Director General
PDC-pharmaceuticals (prescription, non-prescription, disinfectant)	Director	Division manager or reviewer	N/A
PDC-biologics	N/A	N/A	Senior Regulatory Affairs Officer

Table 3. Not satisfactory notice (NSN)

Type	PDD	NNHPD (NDED)	BRDD
CTA or CTA-A	Director General	N/A	Director General
Notifiable changes (NC) (for human biologic or radiopharmaceutical drug quality changes)	N/A	N/A	Review Centre Director
PDC - pharmaceuticals (prescription, non-prescription, disinfectant)	Director	Division manager or reviewer	N/A
PDC - biologics	N/A	N/A	Review Centre Director

Table 4. Notice of deficiency-withdrawal (NOD-W)

Division number	PDD	NNHPD (NDED)	BRDD
Division 8 drugs	Director General	Director General	Director General
Division 1 drugs: DINA DIND DINB)	Director	Division manager	Director General

Table 5. Notice of non-compliance (NON)

Division number	PDD	NNHPD (NDED)	BRDD
Division 8 drugs	Director General	Director General	Director General
Division 1 drugs: DINA DIND DINB	Director	Division manager	Director General

Table 6. Notice of non-compliance – withdrawal (NON-W)

Division number	PDD	NNHPD (NDED)	BRDD
Division 8 drugs	Director General	Director General	Director General
Division 1 drugs: DINA DIND DINB	Director	Division manager	Director General

Table 7. Notice of compliance (NOC)

Division number	PDD	NNHPD (NDED)	BRDD
Division 8 drugs	Director General Manager (generics) Director (administrative)	Director General	Director General